Frail ElderlyMIFNCT02918682
A Multi-component Intervention in Frail Community-dwelling Older People
A study testing Exercise - FIRST PHASE, Exercise - SECOND PHASE and Exercise - FOURTH PHASE in people with Frail Elderly and Exercise Therapy, run by University of Sao Paulo.
Trial summary
This study evaluates if a multi-component intervention, respecting the characteristics of frail older person and increasing intensity and challenge of exercises according to frail older person capacity/evolution will induce better functional results than a multi-component intervention specific to lower body. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly, Exercise Therapy, Physical Therapy Techniques
- What is being tested?
- Exercise - FIRST PHASE, Exercise - SECOND PHASE and Exercise - FOURTH PHASE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- volunteers above the age of 65 who are community residents and classified as frail according to the criteria established by Fried et al. will be selected for inclusion in the study
Who cannot join
- previous lower extremities orthopedic surgery, a history of fractures within the past year, an inability to walk unaided, carriers of neurological diseases, diagnosed acute inflammatory disease that could interfere in the assessments and the program, tumor growth in the last five years and cognitive impairment based on the mini-mental state examination [4]. Moreover, will be excluded volunteers who are absent more than three consecutive training and / or more than 25% of the sessions, and / or present the course of the physical program changes or decompensation and / or disease injury.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of a Multi-component Intervention on the Functional Capacity, Upper and Lower-body Muscle Strength, Balance and Gait in Frail Community-dwelling Older People: a Randomized Clinical Trial
This study evaluates if a multi-component intervention, respecting the characteristics of frail older person and increasing intensity and challenge of exercises according to frail older person capacity/evolution will induce better functional results than a multi-component intervention specific to lower body. the volunteers will be randomized into experimental group and control group.
Read the detailed description
The interventions are separated by day (1 to 24) and by weeks (1 to 12). Each session was built to last between 50 and 60 minutes, beginning with a warming up. In the table are described the exercise as well as the support necessary to perform the exercise safely and necessary equipment (accessories). In cases where a minimum load is required the same are also described in the multimodal intervention protocol (load).
In relation to strength training in the multimodal intervention protocol is described how the progression of intensity will be held. Additional to the load progression suggested, the 1 maximal repetition test will be applied every 4 weeks for adjustment of the loads according to strength gain from each volunteer.
The suggested protocol is based on balance exercises and strength but, in a careful manner, were included functional and mobilization exercises to ensure greater diversity.
Multimodal intervention protocol:
- a week Day 1. Balance Training 1.1 P: Seated on the chair; E: Position Adjustments, (Anterior-posterior, medial-lateral); S: Yes (parallel bar) 1.2 P: Seated on the chair; E: Hip mobilization, Anterior- posterior; S: Yes(parallel bar) Strength Training 1.1 P: Dorsal Decubitus; E: Hip Flexion 1.2 P:Lateral Decubitus; E: Hip Abduction 1.3 P:Seated on the chair; E: Knee Extension 1.4 P:Seated on the chair; E: Dorsiflexion/ Plantar Flexion 1.5 P:Seated on the chair; E: Trunk stabilization; A: Stick
- sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 2. Balance Training 2.1 P: Seated on the chair; E: Position Adjustments (Anterior-posterior, medial-lateral);S: Yes(parallel bar) 2.2 P: Seated on the chair; E: Hip mobilization Anterior- posterior; S: Yes(parallel bar)
Strength Training 2.1 P: Ventral Decubitus; E: Hip Extension (hollowing) 2.2 P:Lateral Decubitus; E: Hip Aduction 2.3 P: Standing; E: Semi-squat; A: peanut ball 2.4 P: Standing; E: Knee Flexion; S: Yes (parallel bar or back rest)
2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
2a week
Day 3. Balance Training 3.1 P:Seated on the chair; E: Trunk mobilization Latero-lateral; S: Yes (parallel bar) 3.2 P:Seated on the chair; E: Trunk mobilization Anterior-posterior; S: Yes(parallel bar) 3.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: Yes(parallel bar) Strength Training 3.1 P: Dorsal Decubitus; E: Hip Flexion 3.2 P:Lateral Decubitus; E: Hip Abduction 3.3 P:Seated on the chair; E: Knee Extension 3.4 P:Seated on the chair; E: Dorsiflexion/ Plantar Flexion 3.5 P:Seated on the chair; E: Trunk stabilization; A: Stick 2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 4. Balance Training 4.1 P:Seated on the chair; E: Trunk mobilization Latero-lateral; S: Yes (parallel bar) 4.2 P:Seated on the chair; E: Trunk mobilization Anterior-posterior; S: No 4.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: Yes(parallel bar) Strength Training 4.1 P:Ventral Decubitus; E: Hip Extension (hollowing) 4.2 P:Lateral Decubitus; E: Hip Aduction 4.3 P: Standing; E: Semi-squat; A: peanut ball 4.4 P: Standing; E: Knee Flexion; S: Yes (parallel bar or back rest )
2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
3a week
Day 5. Balance Training 5.1 P: Standing; E: Side step walking; S: Yes (parallel bar) 5.2 P: Standing; E: Sitting to standing; S: Yes (parallel bar or) back rest 5.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: No 5.4 P: Table pose (Time: 60s )
Strength Training 5.1 P: Dorsal Decubitus; E: Hip Flexion 5.2 P:Lateral Decubitus; E: Hip Abduction 5.3 P:Seated in the chair; E: Knee Extension 5.4 P:Seated on the chair; E: Dorsiflexion/ Plantar Flexion
2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 6. Balance Training 6.1 P: Standing; E:Side step walking; S: Yes (parallel bar) 6.2 P: Standing; E: Sitting to standing; S: Yes (parallel bar or back rest) 6.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: No 6.4 P: Table pose(Time: 60s )
Strength Training 6.1 P:Ventral Decubitus; E: Hip Extension (hollowing + one leg up) 6.2 P:Lateral Decubitus; E: Hip Aduction 6.3 P: Standing; E: Semi-squat; A: peanut ball 6.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)
2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
4a week
Day 7. Balance Training 7.1 P: Standing; E: Walk to Front and Back; S: Yes (parallel bar) 7.2 P: Standing; E: Side step walking; S: No 7.3 P: Seated on the chair; E: Sit to standing; S: Standing: No; Sitting: Yes (parallel bar or back rest) 7.4 P: Table pose(Time: 60s ) 7.5 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: No
Strength Training 7.1 P: Dorsal Decubitus; E: Hip Flexion 7.2 P:Lateral Decubitus; E: Hip Abduction 7.3 P:Seated in the chair; E: Knee Extension 7.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest )
2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 8. Balance Training 8.1 P: Standing; E: Walk to Front and Back; S: Yes (parallel bar) 8.2 P: Standing; E: Side step walking; S: No 8.3 P: Seated on the chair; E: Sit to standing; S: Standing: No; Sitting: Yes(parallel bar or back rest) 8.4 P: Table pose(Time: 60s ) 8.5 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: No
Strength Training 8.1 P:Ventral Decubitus; E: Hip Extension (hollowing + one leg up) 8.2 P:Lateral Decubitus; E: Hip Aduction 8.3 P: Standing; E: Semi-squat; L: 0.5 Kg 8.4 P: Standing; E: Knee Flexion; S: No
2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
5a week
Day 9. Balance Training 9.1 P: Seated on the chair; E: Sitting to standing; S: No 9.2 P: Standing; E: One leg stance; S: Yes(parallel bar) 9.3 P: Standing; E: Walk to Front and Back; S: No 9.4 P: Standing; E: Tandem position; S: No + ocular fixation
Strength Training 9.1 P: Dorsal Decubitus; E:Hip Flexion 9.2 P:Lateral Decubitus; E: Hip Abduction 9.3 P:Seated on the chair; E: Knee Extension 9.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes (parallel bar or back rest)
3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 10. Balance Training 10.1 P: Seated on the chair; E: Sitting to standing; S: No 10.2 P: Standing; E: One leg stance; S: Yes (parallel bar) 10.3 P: Standing; E: Walk to Front and Back; S: No 10.4 P: Standing; E: Tandem position; S: No + ocular fixation
Strength Training 10.1 P: Ventral Decubitus; E: Hip Extension (Table position) 10.2 P:Lateral Decubitus; E: Hip Aduction 10.3 P:Standing; E: Semi-squat; S:No; L:1 Kg 10.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)
3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
6a week
Day 11. Balance Training 11.1 P: Standing; E:Crossed Gait (Braiding); S:Yes (parallel bar) 11.2 P: Standing; E: Turn 90º or 180º; S:Yes(parallel bar) 11.3 P: Standing; Reactive Balance (Ankle, Hip, Step); S:Yes(parallel bar) 11.4 P:Standing; E:Romberg- feet together; S: No+ eyes closed 11.5 P: Standing; E: One leg stance; S: No
Strength Training 11.1 P: Dorsal Decubitus; E:Hip Flexion 11.2 P:Lateral Decubitus; E: Hip Abduction 11.3 P:Seated on the chair; E: Knee Extension 11.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)
3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 12. Balance Training 12.1 P: Standing; E:Crossed Gait (Braiding); S:Yes (parallel bar) 12.2 P: Standing; E: Turn 90º or 180º; S:Yes(parallel bar) 12.3 P: Standing; Reactive Balance (Ankle, Hip, Step); S:Yes(parallel bar) 12.4 P:Standing; E:Romberg- feet together; S: No+ eyes closed 12.5 P: Standing; E: One leg stance; S: No
Strength Training 12.1 P: Ventral Decubitus; E: Hip Extension (Table position) 12.2 P:Lateral Decubitus; E: Hip Aduction 12.3 P:Standing; E: Semi-squat; S:No; L:1 Kg 12.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest) 3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
7a week
Day 13. Balance Training 13.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S: Yes, (parallel bar) 13.2 P: Standing; E: Turn 180º ou 360º; S:Yes(parallel bar) 13.3 P: Standing; E:Walk (6 meters) increasing step length; S: No 13.4 P: Standing; E:Tandem Posture; S: No 13.5 P: Standing; E: One leg stance; S: No + eyes closed
Strength Training 13.1 P: Dorsal Decubitus; E: Hip Flexion 13.2 P:Lateral Decubitus; E: Hip Abduction 13.3 P:Seated on the chair; E: Knee Extension 13.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)
3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 14. Balance Training 14.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S:Yes(parallel bar) 14.2 P: Standing; E: Turn 180º ou 360º; S:Ye(parallel bar)s 14.3 P: Standing; E:Walk (6 meters) increasing step length; S: No 14.4 P: Standing; E:Tandem Posture; S: No 14.5 P: Standing; E: One leg stance; S: No + eyes closed
Strength Training 14.1 P: Ventral Decubitus; E: Hip Extension (Table position) 14.2 P:Lateral Decubitus; E: Hip Aduction 14.3 P:Standing; E: Semi-squat; S:No; L:1 Kg 14.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)
3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
8a week
Day 15. Balance Training 15.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S:No 15.2 P: Standing; E: Tandem Gait; S: Yes(parallel bar) 15.3 P: Standing; E: Step up and down; S: No 15.4 P: Seated on the chair; E:TUG habitual walk speed; S: No 15.5 P:Standing; E:Romberg- feet together; S: No+ ball reach
Strength Training 15.1 P: Dorsal Decubitus; E: Hip Flexion 15.2 P:Lateral Decubitus; E: Hip Abduction 15.3 P:Seated on the chair; E: Knee Extension 15.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)
3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 16. Balance Training 16.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S:No 16.2 P: Standing; E: Tandem Gait; S: Yes(parallel bar) 16.3 P: Standing; E: Step up and down; S: No 16.4 P: Seated on the chair; E:TUG habitual walk speed; S: No 16.5 P:Standing; E:Romberg- feet together; S: No+ ball reach
Strength Training 16.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise one arm) 16.2 P:Lateral Decubitus; E: Hip Aduction 16.3 P:Standing; E: Squat; S:No 16.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest) 3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
9a week
Day 17. Balance Training 17.1 P:Standing; E:Romberg- feet together; S: No+ ball reach 17.2 P: Standing; E: Step up and down; S: No 17.3 P: Seated on the chair; E:TUG habitual walk speed; S: No + Dual task (cognitive) 17.4 P: Standing; E:Walk (6 meters) increasing speed; S: No
Strength Training 17.1 P: Dorsal Decubitus; E:Hip Flexion 17.2 P:Lateral Decubitus; E: Hip Abduction 17.3 P:Seated on the chair; E: knee extension 17.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes (parallel bar or back rest) 3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 18. Balance Training 18.1 P:Standing; E:Romberg- feet together; S: No+ ball reach 18.2 P: Standing; E: Step up and down; S: No 18.3 P: Seated on the chair; E:TUG habitual walk speed; S: No + Dual task (cognitive) 18.4 P: Standing; E:Walk (6 meters) increasing step length; S: No
Strength Training 18.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg) 18.2 P:Lateral Decubitus; E: Hip Aduction 18.3 P:Standing; E: Split Squat; S:No; L:0.5 Kg 18.4 P: Standing; E: Knee Flexion; S: Yes (parallel bar or back rest)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
10a week
Day 19. Balance Training
19.1 P:Standing; E:Romberg- feet together; S: No+ Reach tasks 19.2 P: Standing E:Side step walking; S: No+ ball reach 19.3 P:Standing; E:Romberg- feet together; S: No+ unstable surface+ eyes opened and closed 19.4 P: Standing; E:Walk (6 meters) increasing step length; S: No Strength Training 19.1 P: Dorsal Decubitus; E:Hip Flexion 19.2 P:Lateral Decubitus; E: Hip Abduction 19.3 P:Seated on the chair; E: Knee Extension 19.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes (parallel bar or back res)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 20. Balance Training 20.1 P:Standing; E:Romberg- feet together; S: No+ Reach tasks 20.2 P: Standing; E:Side step walking; S: No+ ball reach 20.3 P: Standing; E: One leg stance; S: No + unstable surface 20.4 P: Standing; E:Walk (6 meters) with scapular dissociation and cervical rotation; S: No
Strength Training 20.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg) 20.2 P:Lateral Decubitus; E: Hip Aduction 20.3 P:Standing; E: Split Squat; S:No; L:0.5 Kg 20.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
11a week
Day 21. Balance Training
Circuit Training:
- Stepping over barriers (Rolls, Steps)
- Gait Training (increasing step length, changing speed, with scapular dissociation and cervical rotation)
- Gait with motor tasks (Ball reach )
- Balance Boards
Strength Training 21.1 P: Dorsal Decubitus; E:Hip Flexion 21.2 P:Lateral Decubitus; E: Hip Abduction 21.3 P:Seated on the chair; E: Knee Extension; S:Yes(parallel bar or back rest) 21.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 22. Balance Training
Circuit Training:
- Stepping over barriers (Rolls, Steps)
- Gait Training (increasing step length, changing speed, with scapular dissociation and cervical rotation)
- Gait with motor tasks (Ball reach)
- Balance Boards
Strength Training
22.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg); L: 0.5 Kg 22.2 P:Lateral Decubitus 22.3 P:Standing; E: Split Squat; S:No; E: Hip Aduction; L:1.0 Kg 22.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
12a week
Day 23. Balance Training
Circuit Training:
1.1 Stepping over barriers (Rolls, Steps) 2.Gait Training (increasing step length, changing speed, with scapular dissociation and cervical rotation) 3.Gait with cognitive tasks 4.Balance Boards
Strength Training
23.1 P: Dorsal Decubitus; E:Hip Flexion 23.2 P:Lateral Decubitus; E: Hip Abduction 23.3 P:Seated on the chair; E: Knee Extension 23.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes (parallel bar or back rest)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 24. Balance Training
Circuit Training:
1.1 Stepping over barriers (Rolls, Steps) 2.Gait Training (increasing step length, changing speed, with scapular dissociation and cervical rotation) 3.Gait with cognitive tasks 4.Balance Boards
Strength Training 24.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg); L: 0.5 Kg 24.2 P:Lateral Decubitus; E: Hip Aduction 24.3 P:Standing; E: Split Squat; S:No; L:0.5 Kg 24.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
- Conditions
- Frail Elderly, Exercise Therapy, Physical Therapy Techniques
- Being tested
- Exercise - FIRST PHASE, Exercise - SECOND PHASE, Exercise - FOURTH PHASE, Exercise - THIRD PHASE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise - FIRST PHASEOther
the participants do not need to perform the first phase or can advance to the second phase if they have obtained the following results in the balance and functional tests: 1. Gait speed of 0.8 m/s and walking 30 meters without stopping; 2. Ability to perform the stand up and sit down test from the chair five times properly within less than 15 seconds; 3. Maintaining the FFEO stance for 30 seconds and the Tandem EO stance for more than 5 seconds; 4. Having sitting stability limits with eyes open; 5. In upright position, able to bend the trunk forward, standing parallel to a wall, between 16.5 - 32 cm but stable. For the muscle strength: being able to perform hip flexion with 50% of 1 repetition maximum (RM) for 8 repetitions; hip extension with 50% of 1RM for 8 repetitions; hip abduction without load but at least for 8 repetitions; knee extension with 50% of 1RM for 8 repetitions; knee flexion with 50 % of 1RM for 8 repetitions;
Exercise - SECOND PHASEOther
the participants do not need to perform the second phase or can advance to the third phase if they have obtained the following results in the balance and functional tests: 1. Gait speed of 0.8-1 m/s and ability to walk 60 meters; 2. Ability to perform the stand up and sit down test from the chair five times properly within less than 15 seconds; 3. Maintaining the FFEO and FFEC stance for more than 5 seconds and the Tandem EO stance for 10-20 seconds; 4. Having sitting stability limits with eyes closed; 5. Being able to bend the trunk forward, standing parallel to a wall, between 20-32 cm ad being stable. For muscle strength: being able to perform hip flexion with 60% of 1 RM for 8 repetitions; hip extension with 60% of 1RM for 8 repetitions; hip abduction without load but between 8-12 repetitions; knee extension with 60% of 1RM for 8 repetitions; knee flexion with 60% of 1RM for 8 repetitions;
Exercise - FOURTH PHASEOther
at the end of the exercise protocol, the participants who have reached the fourth phase must be able to achieve: 1. Gait speed of 0.8-1 m/s and able to walk 90 meters; 2. Stand up and sit down five times from the chair properly within less than 15 seconds; 3. TUG performance less than 14 seconds; 4. Maintenance of 30 seconds in FFEO and FFEC stance, maintenance of 30 seconds in Tandem EO and Tandem EC stance, maintenance of the single-leg stance for more than 21 seconds; 5. Normal sitting stability limits with eyes closed; 6. Bending the trunk forward, standing parallel to a wall, more than 32 cm and being stable. For muscle strength: able to perform hip flexion with 70% of 1 RM for 6-10 repetitions; hip extension with 70% of 1RM for 6-10 repetitions; hip abduction with 40-60% of 1RM for 8-12 repetitions; knee extension with 70% of 1RM for 6-10 repetitions; knee flexion with 70% of 1RM for 6-10 repetitions.
Exercise - THIRD PHASEOther
participants do not need to perform the third phase or can advance to the fourth phase if they have obtained: 1 Gait speed of 0.8-1 m/s and walk 90 meters; 2 perform the stand up and sit down five times from the chair properly within less than 15 seconds; 3 Performing the TUG test within less than 14 seconds; 4 Maintaining the FFEO and FFEC stance for 30 seconds, maintaining the Tandem EO and Tandem EC stance for 30 seconds and maintaining the single-leg stance for more than 20 seconds; 5 Having sitting stability limits with eyes closed; 6 In the upright position, to bend the trunk forward, standing parallel to a wall, more than 32 cm and being stable. For the muscle strength test, perform hip flexion with 60 % of 1 RM for 8-12 repetitions; hip extension with 60 % of 1RM for 8-12 repetitions; hip abduction without load or 5% of 1RM for hip abductor and between 8-12 repetitions; knee extension with 60 % of 1RM for 8-12 repetitions; knee flexion with 60 % of 1RM for 8-12 repetitions;
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | The multimodal intervention protocol is described separated by day (1 to 24) and by weeks (1 to 12). Each session was built to last between 50 and 60 minutes. Receives: Other: Exercise - FIRST PHASE; Other: Exercise - SECOND PHASE; Other: Exercise - FOURTH PHASE; Other: Exercise - THIRD PHASE |
| Control Group | No intervention | Participants from the control group will not perform any kind of physical exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
strength muscle evaluation
The Elbow flexors and extensors, trunk flexors and extensors, hip abductor and adductor, knee flexors and extensors and ankle dorsiflexors and plantarflexors muscle strength of the dominant limb will be evaluated by an isokinetic dynamometer
Measured: baseline
Balance
Balance in semi-static stance was measured using the force platform. Data on 6 stances were collected for each subject: standing on a fixed platform with eyes open and closed; standing on an unstable platform with eyes open and closed; and in single-leg stance with eyes open on the right leg and on the left leg.
Measured: baseline
gait
The gait parameters will be analyzed using the GAITRite Platinum 26' Portable Walkway System to evaluated spatial and temporal gait variables.
Measured: baseline
functional performance
Timed Up and Go (TUG) test will be used.
Measured: baseline
Secondary outcomes (4)
strength muscle evaluation
The Elbow flexors and extensors, trunk flexors and extensors, hip abductor and adductor, knee flexors and extensors and ankle dorsiflexors and plantarflexors muscle strength of the dominant limb will be evaluated by an isokinetic dynamometer
Measured: change from baseline in 3 months
Balance
Balance in semi-static stance was measured using the force platform. Data on 6 stances were collected for each subject: standing on a fixed platform with eyes open and closed; standing on an unstable platform with eyes open and closed; and in single-leg stance with eyes open on the right leg and on the left leg.
Measured: change from baseline in 3 months
gait
The gait parameters will be analyzed using the GAITRite Platinum 26' Portable Walkway System to evaluated spatial and temporal gait variables.
Measured: change from baseline in 3 months
functional performance
Timed Up and Go (TUG) test will be used.
Measured: change from baseline in 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startDec 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the participants do not need to perform the first phase or can advance to the second phase if they have obtained the following results in the balance and functional tests: 1. Gait speed of 0.8 m/s and walking 30 meters without stopping; 2. Ability to perform the stand up and sit down test from the chair five times properly within less than 15 seconds; 3. Maintaining the FFEO stance for 30 seconds and the Tandem EO stance for more than 5 seconds; 4. Having sitting stability limits with eyes open; 5. In upright position, able to bend the trunk forward, standing parallel to a wall, between 16.5 - 32 cm but stable. For the muscle strength: being able to perform hip flexion with 50% of 1 repetition maximum (RM) for 8 repetitions; hip extension with 50% of 1RM for 8 repetitions; hip abduction without load but at least for 8 repetitions; knee extension with 50% of 1RM for 8 repetitions; knee flexion with 50 % of 1RM for 8 repetitions;
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Daniela Cristina Carvalho de Abreu, University of Sao Paulo
- Investigators
- Daniela CC de Abreu, Professor, Study chair, School of Medicine of RibeirãoPreto, University of São Paulo, FMRP-USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918682
- Sponsor's protocol ID
- 932.043
- Acronym
- MIF
- Status last verified
- Apr 2019
- First submitted
- 26 Sep 2016
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the end of the protocol and the data evaluation, the results will be send to each participant.
Publications
de Labra C, Guimaraes-Pinheiro C, Maseda A, Lorenzo T, Millan-Calenti JC. Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials. BMC Geriatr. 2015 Dec 2;15:154. doi: 10.1186/s12877-015-0155-4.
PubMed 26626157Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.
PubMed 15031310Lustosa LP, Coelho FM, Silva JP, Pereira DS, Parentoni AN, Dias JM, Dias RC, Pereira LS. The effects of a muscle resistance program on the functional capacity, knee extensor muscle strength and plasma levels of IL-6 and TNF-alpha in pre-frail elderly women: a randomized crossover clinical trial--a study protocol. Trials. 2010 Jul 28;11:82. doi: 10.1186/1745-6215-11-82.
PubMed 20667082Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Ashfield TA, Syddall HE, Martin HJ, Dennison EM, Cooper C, Aihie Sayer A. Grip strength and cardiovascular drug use in older people: findings from the Hertfordshire Cohort Study. Age Ageing. 2010 Mar;39(2):185-91. doi: 10.1093/ageing/afp203. Epub 2009 Dec 17.
PubMed 20019032Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
PubMed 23395245McPhee JS, French DP, Jackson D, Nazroo J, Pendleton N, Degens H. Physical activity in older age: perspectives for healthy ageing and frailty. Biogerontology. 2016 Jun;17(3):567-80. doi: 10.1007/s10522-016-9641-0. Epub 2016 Mar 2.
PubMed 26936444Gobbens RJ, Luijkx KG, Wijnen-Sponselee MT, Schols JM. Toward a conceptual definition of frail community dwelling older people. Nurs Outlook. 2010 Mar-Apr;58(2):76-86. doi: 10.1016/j.outlook.2009.09.005.
PubMed 20362776Gine-Garriga M, Guerra M, Pages E, Manini TM, Jimenez R, Unnithan VB. The effect of functional circuit training on physical frailty in frail older adults: a randomized controlled trial. J Aging Phys Act. 2010 Oct;18(4):401-24. doi: 10.1123/japa.18.4.401.
PubMed 20956842Gine-Garriga M, Guerra M, Unnithan VB. The effect of functional circuit training on self-reported fear of falling and health status in a group of physically frail older individuals: a randomized controlled trial. Aging Clin Exp Res. 2013 Jun;25(3):329-36. doi: 10.1007/s40520-013-0048-3. Epub 2013 May 17.
PubMed 23740589Aguirre LE, Villareal DT. Physical Exercise as Therapy for Frailty. Nestle Nutr Inst Workshop Ser. 2015;83:83-92. doi: 10.1159/000382065. Epub 2015 Nov 2.
PubMed 26524568Ng TP, Feng L, Nyunt MS, Feng L, Niti M, Tan BY, Chan G, Khoo SA, Chan SM, Yap P, Yap KB. Nutritional, Physical, Cognitive, and Combination Interventions and Frailty Reversal Among Older Adults: A Randomized Controlled Trial. Am J Med. 2015 Nov;128(11):1225-1236.e1. doi: 10.1016/j.amjmed.2015.06.017. Epub 2015 Jul 6.
PubMed 26159634American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.
PubMed 19516148Fairhall N, Sherrington C, Lord SR, Kurrle SE, Langron C, Lockwood K, Monaghan N, Aggar C, Cameron ID. Effect of a multifactorial, interdisciplinary intervention on risk factors for falls and fall rate in frail older people: a randomised controlled trial. Age Ageing. 2014 Sep;43(5):616-22. doi: 10.1093/ageing/aft204. Epub 2013 Dec 30.
PubMed 24381025Lustosa LP, Silva JP, Coelho FM, Pereira DS, Parentoni AN, Pereira LS. Impact of resistance exercise program on functional capacity and muscular strength of knee extensor in pre-frail community-dwelling older women: a randomized crossover trial. Rev Bras Fisioter. 2011 Aug-Sep;15(4):318-24. English, Portuguese.
PubMed 21971726
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Multi-component Intervention on the Functional Capacity, Upper and Lower-body Muscle Strength, Balance and Gait in Frail Community-dwelling Older People: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02918682
- Acronym / sponsor ID
- MIF / 932.043
- Conditions
- Frail Elderly, Exercise Therapy, Physical Therapy Techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates if a multi-component intervention, respecting the characteristics of frail older person and increasing intensity and challenge of exercises according to frail older person capacity/evolution will induce better functional results than a multi-component intervention specific to lower body. the volunteers will be randomized into experimental group and control group.
Detailed description
The interventions are separated by day (1 to 24) and by weeks (1 to 12). Each session was built to last between 50 and 60 minutes, beginning with a warming up. In the table are described the exercise as well as the support necessary to perform the exercise safely and necessary equipment (accessories). In cases where a minimum load is required the same are also described in the multimodal intervention protocol (load).
In relation to strength training in the multimodal intervention protocol is described how the progression of intensity will be held. Additional to the load progression suggested, the 1 maximal repetition test will be applied every 4 weeks for adjustment of the loads according to strength gain from each volunteer.
The suggested protocol is based on balance exercises and strength but, in a careful manner, were included functional and mobilization exercises to ensure greater diversity.
Multimodal intervention protocol:
- a week Day 1. Balance Training 1.1 P: Seated on the chair; E: Position Adjustments, (Anterior-posterior, medial-lateral); S: Yes (parallel bar) 1.2 P: Seated on the chair; E: Hip mobilization, Anterior- posterior; S: Yes(parallel bar) Strength Training 1.1 P: Dorsal Decubitus; E: Hip Flexion 1.2 P:Lateral Decubitus; E: Hip Abduction 1.3 P:Seated on the chair; E: Knee Extension 1.4 P:Seated on the chair; E: Dorsiflexion/ Plantar Flexion 1.5 P:Seated on the chair; E: Trunk stabilization; A: Stick
- sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 2. Balance Training 2.1 P: Seated on the chair; E: Position Adjustments (Anterior-posterior, medial-lateral);S: Yes(parallel bar) 2.2 P: Seated on the chair; E: Hip mobilization Anterior- posterior; S: Yes(parallel bar)
Strength Training 2.1 P: Ventral Decubitus; E: Hip Extension (hollowing) 2.2 P:Lateral Decubitus; E: Hip Aduction 2.3 P: Standing; E: Semi-squat; A: peanut ball 2.4 P: Standing; E: Knee Flexion; S: Yes (parallel bar or back rest)
2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
2a week
Day 3. Balance Training 3.1 P:Seated on the chair; E: Trunk mobilization Latero-lateral; S: Yes (parallel bar) 3.2 P:Seated on the chair; E: Trunk mobilization Anterior-posterior; S: Yes(parallel bar) 3.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: Yes(parallel bar) Strength Training 3.1 P: Dorsal Decubitus; E: Hip Flexion 3.2 P:Lateral Decubitus; E: Hip Abduction 3.3 P:Seated on the chair; E: Knee Extension 3.4 P:Seated on the chair; E: Dorsiflexion/ Plantar Flexion 3.5 P:Seated on the chair; E: Trunk stabilization; A: Stick 2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 4. Balance Training 4.1 P:Seated on the chair; E: Trunk mobilization Latero-lateral; S: Yes (parallel bar) 4.2 P:Seated on the chair; E: Trunk mobilization Anterior-posterior; S: No 4.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: Yes(parallel bar) Strength Training 4.1 P:Ventral Decubitus; E: Hip Extension (hollowing) 4.2 P:Lateral Decubitus; E: Hip Aduction 4.3 P: Standing; E: Semi-squat; A: peanut ball 4.4 P: Standing; E: Knee Flexion; S: Yes (parallel bar or back rest )
2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
3a week
Day 5. Balance Training 5.1 P: Standing; E: Side step walking; S: Yes (parallel bar) 5.2 P: Standing; E: Sitting to standing; S: Yes (parallel bar or) back rest 5.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: No 5.4 P: Table pose (Time: 60s )
Strength Training 5.1 P: Dorsal Decubitus; E: Hip Flexion 5.2 P:Lateral Decubitus; E: Hip Abduction 5.3 P:Seated in the chair; E: Knee Extension 5.4 P:Seated on the chair; E: Dorsiflexion/ Plantar Flexion
2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 6. Balance Training 6.1 P: Standing; E:Side step walking; S: Yes (parallel bar) 6.2 P: Standing; E: Sitting to standing; S: Yes (parallel bar or back rest) 6.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: No 6.4 P: Table pose(Time: 60s )
Strength Training 6.1 P:Ventral Decubitus; E: Hip Extension (hollowing + one leg up) 6.2 P:Lateral Decubitus; E: Hip Aduction 6.3 P: Standing; E: Semi-squat; A: peanut ball 6.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)
2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
4a week
Day 7. Balance Training 7.1 P: Standing; E: Walk to Front and Back; S: Yes (parallel bar) 7.2 P: Standing; E: Side step walking; S: No 7.3 P: Seated on the chair; E: Sit to standing; S: Standing: No; Sitting: Yes (parallel bar or back rest) 7.4 P: Table pose(Time: 60s ) 7.5 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: No
Strength Training 7.1 P: Dorsal Decubitus; E: Hip Flexion 7.2 P:Lateral Decubitus; E: Hip Abduction 7.3 P:Seated in the chair; E: Knee Extension 7.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest )
2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 8. Balance Training 8.1 P: Standing; E: Walk to Front and Back; S: Yes (parallel bar) 8.2 P: Standing; E: Side step walking; S: No 8.3 P: Seated on the chair; E: Sit to standing; S: Standing: No; Sitting: Yes(parallel bar or back rest) 8.4 P: Table pose(Time: 60s ) 8.5 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: No
Strength Training 8.1 P:Ventral Decubitus; E: Hip Extension (hollowing + one leg up) 8.2 P:Lateral Decubitus; E: Hip Aduction 8.3 P: Standing; E: Semi-squat; L: 0.5 Kg 8.4 P: Standing; E: Knee Flexion; S: No
2 sets, 12 repetitions, 50% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
5a week
Day 9. Balance Training 9.1 P: Seated on the chair; E: Sitting to standing; S: No 9.2 P: Standing; E: One leg stance; S: Yes(parallel bar) 9.3 P: Standing; E: Walk to Front and Back; S: No 9.4 P: Standing; E: Tandem position; S: No + ocular fixation
Strength Training 9.1 P: Dorsal Decubitus; E:Hip Flexion 9.2 P:Lateral Decubitus; E: Hip Abduction 9.3 P:Seated on the chair; E: Knee Extension 9.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes (parallel bar or back rest)
3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 10. Balance Training 10.1 P: Seated on the chair; E: Sitting to standing; S: No 10.2 P: Standing; E: One leg stance; S: Yes (parallel bar) 10.3 P: Standing; E: Walk to Front and Back; S: No 10.4 P: Standing; E: Tandem position; S: No + ocular fixation
Strength Training 10.1 P: Ventral Decubitus; E: Hip Extension (Table position) 10.2 P:Lateral Decubitus; E: Hip Aduction 10.3 P:Standing; E: Semi-squat; S:No; L:1 Kg 10.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)
3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
6a week
Day 11. Balance Training 11.1 P: Standing; E:Crossed Gait (Braiding); S:Yes (parallel bar) 11.2 P: Standing; E: Turn 90º or 180º; S:Yes(parallel bar) 11.3 P: Standing; Reactive Balance (Ankle, Hip, Step); S:Yes(parallel bar) 11.4 P:Standing; E:Romberg- feet together; S: No+ eyes closed 11.5 P: Standing; E: One leg stance; S: No
Strength Training 11.1 P: Dorsal Decubitus; E:Hip Flexion 11.2 P:Lateral Decubitus; E: Hip Abduction 11.3 P:Seated on the chair; E: Knee Extension 11.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)
3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 12. Balance Training 12.1 P: Standing; E:Crossed Gait (Braiding); S:Yes (parallel bar) 12.2 P: Standing; E: Turn 90º or 180º; S:Yes(parallel bar) 12.3 P: Standing; Reactive Balance (Ankle, Hip, Step); S:Yes(parallel bar) 12.4 P:Standing; E:Romberg- feet together; S: No+ eyes closed 12.5 P: Standing; E: One leg stance; S: No
Strength Training 12.1 P: Ventral Decubitus; E: Hip Extension (Table position) 12.2 P:Lateral Decubitus; E: Hip Aduction 12.3 P:Standing; E: Semi-squat; S:No; L:1 Kg 12.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest) 3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
7a week
Day 13. Balance Training 13.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S: Yes, (parallel bar) 13.2 P: Standing; E: Turn 180º ou 360º; S:Yes(parallel bar) 13.3 P: Standing; E:Walk (6 meters) increasing step length; S: No 13.4 P: Standing; E:Tandem Posture; S: No 13.5 P: Standing; E: One leg stance; S: No + eyes closed
Strength Training 13.1 P: Dorsal Decubitus; E: Hip Flexion 13.2 P:Lateral Decubitus; E: Hip Abduction 13.3 P:Seated on the chair; E: Knee Extension 13.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)
3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 14. Balance Training 14.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S:Yes(parallel bar) 14.2 P: Standing; E: Turn 180º ou 360º; S:Ye(parallel bar)s 14.3 P: Standing; E:Walk (6 meters) increasing step length; S: No 14.4 P: Standing; E:Tandem Posture; S: No 14.5 P: Standing; E: One leg stance; S: No + eyes closed
Strength Training 14.1 P: Ventral Decubitus; E: Hip Extension (Table position) 14.2 P:Lateral Decubitus; E: Hip Aduction 14.3 P:Standing; E: Semi-squat; S:No; L:1 Kg 14.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)
3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
8a week
Day 15. Balance Training 15.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S:No 15.2 P: Standing; E: Tandem Gait; S: Yes(parallel bar) 15.3 P: Standing; E: Step up and down; S: No 15.4 P: Seated on the chair; E:TUG habitual walk speed; S: No 15.5 P:Standing; E:Romberg- feet together; S: No+ ball reach
Strength Training 15.1 P: Dorsal Decubitus; E: Hip Flexion 15.2 P:Lateral Decubitus; E: Hip Abduction 15.3 P:Seated on the chair; E: Knee Extension 15.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)
3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 16. Balance Training 16.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S:No 16.2 P: Standing; E: Tandem Gait; S: Yes(parallel bar) 16.3 P: Standing; E: Step up and down; S: No 16.4 P: Seated on the chair; E:TUG habitual walk speed; S: No 16.5 P:Standing; E:Romberg- feet together; S: No+ ball reach
Strength Training 16.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise one arm) 16.2 P:Lateral Decubitus; E: Hip Aduction 16.3 P:Standing; E: Squat; S:No 16.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest) 3 sets, 10 repetitions, 55-65% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
9a week
Day 17. Balance Training 17.1 P:Standing; E:Romberg- feet together; S: No+ ball reach 17.2 P: Standing; E: Step up and down; S: No 17.3 P: Seated on the chair; E:TUG habitual walk speed; S: No + Dual task (cognitive) 17.4 P: Standing; E:Walk (6 meters) increasing speed; S: No
Strength Training 17.1 P: Dorsal Decubitus; E:Hip Flexion 17.2 P:Lateral Decubitus; E: Hip Abduction 17.3 P:Seated on the chair; E: knee extension 17.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes (parallel bar or back rest) 3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 18. Balance Training 18.1 P:Standing; E:Romberg- feet together; S: No+ ball reach 18.2 P: Standing; E: Step up and down; S: No 18.3 P: Seated on the chair; E:TUG habitual walk speed; S: No + Dual task (cognitive) 18.4 P: Standing; E:Walk (6 meters) increasing step length; S: No
Strength Training 18.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg) 18.2 P:Lateral Decubitus; E: Hip Aduction 18.3 P:Standing; E: Split Squat; S:No; L:0.5 Kg 18.4 P: Standing; E: Knee Flexion; S: Yes (parallel bar or back rest)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
10a week
Day 19. Balance Training
19.1 P:Standing; E:Romberg- feet together; S: No+ Reach tasks 19.2 P: Standing E:Side step walking; S: No+ ball reach 19.3 P:Standing; E:Romberg- feet together; S: No+ unstable surface+ eyes opened and closed 19.4 P: Standing; E:Walk (6 meters) increasing step length; S: No Strength Training 19.1 P: Dorsal Decubitus; E:Hip Flexion 19.2 P:Lateral Decubitus; E: Hip Abduction 19.3 P:Seated on the chair; E: Knee Extension 19.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes (parallel bar or back res)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 20. Balance Training 20.1 P:Standing; E:Romberg- feet together; S: No+ Reach tasks 20.2 P: Standing; E:Side step walking; S: No+ ball reach 20.3 P: Standing; E: One leg stance; S: No + unstable surface 20.4 P: Standing; E:Walk (6 meters) with scapular dissociation and cervical rotation; S: No
Strength Training 20.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg) 20.2 P:Lateral Decubitus; E: Hip Aduction 20.3 P:Standing; E: Split Squat; S:No; L:0.5 Kg 20.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
11a week
Day 21. Balance Training
Circuit Training:
- Stepping over barriers (Rolls, Steps)
- Gait Training (increasing step length, changing speed, with scapular dissociation and cervical rotation)
- Gait with motor tasks (Ball reach )
- Balance Boards
Strength Training 21.1 P: Dorsal Decubitus; E:Hip Flexion 21.2 P:Lateral Decubitus; E: Hip Abduction 21.3 P:Seated on the chair; E: Knee Extension; S:Yes(parallel bar or back rest) 21.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 22. Balance Training
Circuit Training:
- Stepping over barriers (Rolls, Steps)
- Gait Training (increasing step length, changing speed, with scapular dissociation and cervical rotation)
- Gait with motor tasks (Ball reach)
- Balance Boards
Strength Training
22.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg); L: 0.5 Kg 22.2 P:Lateral Decubitus 22.3 P:Standing; E: Split Squat; S:No; E: Hip Aduction; L:1.0 Kg 22.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
12a week
Day 23. Balance Training
Circuit Training:
1.1 Stepping over barriers (Rolls, Steps) 2.Gait Training (increasing step length, changing speed, with scapular dissociation and cervical rotation) 3.Gait with cognitive tasks 4.Balance Boards
Strength Training
23.1 P: Dorsal Decubitus; E:Hip Flexion 23.2 P:Lateral Decubitus; E: Hip Abduction 23.3 P:Seated on the chair; E: Knee Extension 23.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes (parallel bar or back rest)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Day 24. Balance Training
Circuit Training:
1.1 Stepping over barriers (Rolls, Steps) 2.Gait Training (increasing step length, changing speed, with scapular dissociation and cervical rotation) 3.Gait with cognitive tasks 4.Balance Boards
Strength Training 24.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg); L: 0.5 Kg 24.2 P:Lateral Decubitus; E: Hip Aduction 24.3 P:Standing; E: Split Squat; S:No; L:0.5 Kg 24.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)
3 sets, 8 repetitions, 65-75% RM
P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- the participants do not need to perform the first phase or can advance to the second phase if they have obtained the following results in the balance and functional tests: 1. Gait speed of 0.8 m/s and walking 30 meters without stopping; 2. Ability to perform the stand up and sit down test from the chair five times properly within less than 15 seconds; 3. Maintaining the FFEO stance for 30 seconds and the Tandem EO stance for more than 5 seconds; 4. Having sitting stability limits with eyes open; 5. In upright position, able to bend the trunk forward, standing parallel to a wall, between 16.5 - 32 cm but stable. For the muscle strength: being able to perform hip flexion with 50% of 1 repetition maximum (RM) for 8 repetitions; hip extension with 50% of 1RM for 8 repetitions; hip abduction without load but at least for 8 repetitions; knee extension with 50% of 1RM for 8 repetitions; knee flexion with 50 % of 1RM for 8 repetitions;
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Exercise - FIRST PHASE, Other: Exercise - SECOND PHASE, Other: Exercise - FOURTH PHASE, Other: Exercise - THIRD PHASEThe multimodal intervention protocol is described separated by day (1 to 24) and by weeks (1 to 12). Each session was built to last between 50 and 60 minutes. |
| Control Group | No intervention | –Participants from the control group will not perform any kind of physical exercise. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- volunteers above the age of 65 who are community residents and classified as frail according to the criteria established by Fried et al. will be selected for inclusion in the study
Key exclusion criteria (1 listed)
- previous lower extremities orthopedic surgery, a history of fractures within the past year, an inability to walk unaided, carriers of neurological diseases, diagnosed acute inflammatory disease that could interfere in the assessments and the program, tumor growth in the last five years and cognitive impairment based on the mini-mental state examination [4]. Moreover, will be excluded volunteers who are absent more than three consecutive training and / or more than 25% of the sessions, and / or present the course of the physical program changes or decompensation and / or disease injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise - FIRST PHASEthe participants do not need to perform the first phase or can advance to the second phase if they have obtained the following results in the balance and functional tests: 1. Gait speed of 0.8 m/s and walking 30 meters without stopping; 2. Ability to perform the stand up and sit down test from the chair five times properly within less than 15 seconds; 3. Maintaining the FFEO stance for 30 seconds and the Tandem EO stance for more than 5 seconds; 4. Having sitting stability limits with eyes open; 5. In upright position, able to bend the trunk forward, standing parallel to a wall, between 16.5 - 32 cm but stable. For the muscle strength: being able to perform hip flexion with 50% of 1 repetition maximum (RM) for 8 repetitions; hip extension with 50% of 1RM for 8 repetitions; hip abduction without load but at least for 8 repetitions; knee extension with 50% of 1RM for 8 repetitions; knee flexion with 50 % of 1RM for 8 repetitions; | Other | Exercise Group |
| Exercise - SECOND PHASEthe participants do not need to perform the second phase or can advance to the third phase if they have obtained the following results in the balance and functional tests: 1. Gait speed of 0.8-1 m/s and ability to walk 60 meters; 2. Ability to perform the stand up and sit down test from the chair five times properly within less than 15 seconds; 3. Maintaining the FFEO and FFEC stance for more than 5 seconds and the Tandem EO stance for 10-20 seconds; 4. Having sitting stability limits with eyes closed; 5. Being able to bend the trunk forward, standing parallel to a wall, between 20-32 cm ad being stable. For muscle strength: being able to perform hip flexion with 60% of 1 RM for 8 repetitions; hip extension with 60% of 1RM for 8 repetitions; hip abduction without load but between 8-12 repetitions; knee extension with 60% of 1RM for 8 repetitions; knee flexion with 60% of 1RM for 8 repetitions; | Other | Exercise Group |
| Exercise - FOURTH PHASEat the end of the exercise protocol, the participants who have reached the fourth phase must be able to achieve: 1. Gait speed of 0.8-1 m/s and able to walk 90 meters; 2. Stand up and sit down five times from the chair properly within less than 15 seconds; 3. TUG performance less than 14 seconds; 4. Maintenance of 30 seconds in FFEO and FFEC stance, maintenance of 30 seconds in Tandem EO and Tandem EC stance, maintenance of the single-leg stance for more than 21 seconds; 5. Normal sitting stability limits with eyes closed; 6. Bending the trunk forward, standing parallel to a wall, more than 32 cm and being stable. For muscle strength: able to perform hip flexion with 70% of 1 RM for 6-10 repetitions; hip extension with 70% of 1RM for 6-10 repetitions; hip abduction with 40-60% of 1RM for 8-12 repetitions; knee extension with 70% of 1RM for 6-10 repetitions; knee flexion with 70% of 1RM for 6-10 repetitions. | Other | Exercise Group |
| Exercise - THIRD PHASEparticipants do not need to perform the third phase or can advance to the fourth phase if they have obtained: 1 Gait speed of 0.8-1 m/s and walk 90 meters; 2 perform the stand up and sit down five times from the chair properly within less than 15 seconds; 3 Performing the TUG test within less than 14 seconds; 4 Maintaining the FFEO and FFEC stance for 30 seconds, maintaining the Tandem EO and Tandem EC stance for 30 seconds and maintaining the single-leg stance for more than 20 seconds; 5 Having sitting stability limits with eyes closed; 6 In the upright position, to bend the trunk forward, standing parallel to a wall, more than 32 cm and being stable. For the muscle strength test, perform hip flexion with 60 % of 1 RM for 8-12 repetitions; hip extension with 60 % of 1RM for 8-12 repetitions; hip abduction without load or 5% of 1RM for hip abductor and between 8-12 repetitions; knee extension with 60 % of 1RM for 8-12 repetitions; knee flexion with 60 % of 1RM for 8-12 repetitions; | Other | Exercise Group |
Primary outcome
strength muscle evaluation
Time frame: baseline
The Elbow flexors and extensors, trunk flexors and extensors, hip abductor and adductor, knee flexors and extensors and ankle dorsiflexors and plantarflexors muscle strength of the dominant limb will be evaluated by an isokinetic dynamometer
Balance
Time frame: baseline
Balance in semi-static stance was measured using the force platform. Data on 6 stances were collected for each subject: standing on a fixed platform with eyes open and closed; standing on an unstable platform with eyes open and closed; and in single-leg stance with eyes open on the right leg and on the left leg.
gait
Time frame: baseline
The gait parameters will be analyzed using the GAITRite Platinum 26' Portable Walkway System to evaluated spatial and temporal gait variables.
functional performance
Time frame: baseline
Timed Up and Go (TUG) test will be used.
4 secondary outcomes
strength muscle evaluation
Time frame: change from baseline in 3 months
Balance
Time frame: change from baseline in 3 months
gait
Time frame: change from baseline in 3 months
functional performance
Time frame: change from baseline in 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Background: PubMed 26626157de Labra C, Guimaraes-Pinheiro C, Maseda A, Lorenzo T, Millan-Calenti JC. Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials. BMC Geriatr. 2015 Dec 2;15:154. doi: 10.1186/s12877-015-0155-4.
- Background: PubMed 15031310Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.
- Background: PubMed 20667082Lustosa LP, Coelho FM, Silva JP, Pereira DS, Parentoni AN, Dias JM, Dias RC, Pereira LS. The effects of a muscle resistance program on the functional capacity, knee extensor muscle strength and plasma levels of IL-6 and TNF-alpha in pre-frail elderly women: a randomized crossover clinical trial--a study protocol. Trials. 2010 Jul 28;11:82. doi: 10.1186/1745-6215-11-82.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 20019032Ashfield TA, Syddall HE, Martin HJ, Dennison EM, Cooper C, Aihie Sayer A. Grip strength and cardiovascular drug use in older people: findings from the Hertfordshire Cohort Study. Age Ageing. 2010 Mar;39(2):185-91. doi: 10.1093/ageing/afp203. Epub 2009 Dec 17.
- Background: PubMed 23395245Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Background: PubMed 26936444McPhee JS, French DP, Jackson D, Nazroo J, Pendleton N, Degens H. Physical activity in older age: perspectives for healthy ageing and frailty. Biogerontology. 2016 Jun;17(3):567-80. doi: 10.1007/s10522-016-9641-0. Epub 2016 Mar 2.
- Background: PubMed 20362776Gobbens RJ, Luijkx KG, Wijnen-Sponselee MT, Schols JM. Toward a conceptual definition of frail community dwelling older people. Nurs Outlook. 2010 Mar-Apr;58(2):76-86. doi: 10.1016/j.outlook.2009.09.005.
- Background: PubMed 20956842Gine-Garriga M, Guerra M, Pages E, Manini TM, Jimenez R, Unnithan VB. The effect of functional circuit training on physical frailty in frail older adults: a randomized controlled trial. J Aging Phys Act. 2010 Oct;18(4):401-24. doi: 10.1123/japa.18.4.401.
- Background: PubMed 23740589Gine-Garriga M, Guerra M, Unnithan VB. The effect of functional circuit training on self-reported fear of falling and health status in a group of physically frail older individuals: a randomized controlled trial. Aging Clin Exp Res. 2013 Jun;25(3):329-36. doi: 10.1007/s40520-013-0048-3. Epub 2013 May 17.
- Background: PubMed 26524568Aguirre LE, Villareal DT. Physical Exercise as Therapy for Frailty. Nestle Nutr Inst Workshop Ser. 2015;83:83-92. doi: 10.1159/000382065. Epub 2015 Nov 2.
- Background: PubMed 26159634Ng TP, Feng L, Nyunt MS, Feng L, Niti M, Tan BY, Chan G, Khoo SA, Chan SM, Yap P, Yap KB. Nutritional, Physical, Cognitive, and Combination Interventions and Frailty Reversal Among Older Adults: A Randomized Controlled Trial. Am J Med. 2015 Nov;128(11):1225-1236.e1. doi: 10.1016/j.amjmed.2015.06.017. Epub 2015 Jul 6.
- World Health Organization. Active ageing: a policy framework.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the end of the protocol and the data evaluation, the results will be send to each participant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela CC de Abreu, Professor study chair
School of Medicine of RibeirãoPreto, University of São Paulo, FMRP-USP
Questions about this trial
What is this clinical trial studying?
A study testing Exercise - FIRST PHASE, Exercise - SECOND PHASE and Exercise - FOURTH PHASE in people with Frail Elderly and Exercise Therapy, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalia C Rodrigues, PhD (+55 16 33154413, nataliacrod@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
strength muscle evaluation (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02918682, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.