Elderly WomenACTIVENCT03892278
Effects of Water-based Aerobic and Combined Training in Elderly Woman
A study testing Water-based aerobic training and Water-based aerobic and combined training in people with Elderly Women, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
Purpose: Investigate neuromuscular, cardiorespiratory, functional capacity, quality of life and cognitive adaptations of eight weeks of water-based aerobic and combined training in elderly women previously trained for eight weeks of water-based aerobic training. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elderly Women
- What is being tested?
- Water-based aerobic training and Water-based aerobic and combined training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Jan 2019to 15 Dec 2020
- 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 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer elderly women, aged between 60-75 years old who were not participating on any regular training program in the last four months
Who cannot join
- Cardiovascular disease (except hypertension controlled by medication);
- Physical impairments for exercise diagnosed through anamnesis;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Pelotas
Pelotas, Rio Grande do Sul, 96055-630
About this study
Official title: Effects of 16 Weeks of Different Water-based Training Programs on Neuromuscular, Cardiorespiratory, Functional Capacity, Quality of Life and Cognitive Function Variables in Elderly Woman: a Randomized Clinical Trial
Purpose: Investigate neuromuscular, cardiorespiratory, functional capacity, quality of life and cognitive adaptations of eight weeks of water-based aerobic and combined training in elderly women previously trained for eight weeks of water-based aerobic training.
Materials and methods: Fifty-four elderly women volunteer will be randomly divided into two groups with ratio of 2:1 (week 0): water-based aerobic training (WBA) and control group (CG). After eight weeks of intervention the WBA group will be randomly divided into two groups with ratio of 1:1 (week 9): WBA and water-based combined training (WBC). The intervention will last 16 weeks with two weekly sessions for water-based training groups and one weekly session for CG. The WBA program will consist only of aerobic exercises while the WBC program will consist of aerobic and resistance exercises in the same session. The WBA training will be performed in the percentages of heart rate corresponding to the anaerobic threshold and the resistance training sets will be performed at maximal effort. Assessments of muscular endurance of knee extensors and elbow flexors, peak oxygen consumption and ventilatory thresholds, occurrence of low back pain and disability from the same, functional capacity (30-second chair stand, 8-foot up-and-go and chair sit-and-reach) and of functional test 8-foot up-and-go with counting task will be performed before (week 0) and after interventions (week 17). Moreover, assessments of maximal dynamic strength in knee extensors and elbow flexors, maximal neuromuscular activity and maximal voluntary isometric contraction of knee extensor muscles, muscle thickness and echo intensity of knee extensor muscles, heart rate, blood pressure, functional capacity (6-minute walk), quality of life and cognitive function will be performed before (week 0), between (week 9) and after interventions (week 17). The data will be analyzed using Generalized Estimating Equations (GEE) and Bonferroni post-hoc test (α=0,05).
Read the detailed description
Aging process has its own characteristics, among which the direct association with reductions in muscle mass, muscle strength and cardiorespiratory fitness are highlighted. These reductions cause impairment in functional capacity, affecting the efficiency of elderly individuals to perform daily living tasks. However regular exercise practice can be efficient to mitigate factors associated with aging.
A modality that has been well suited for individuals over 60 years is the water-based exercises training, precisely due to the beneficial conditions of the aquatic environment, such as the lower impact on the lower limbs joints in comparison to the impact observed during exercises performed on land
The aim of the study is to investigate neuromuscular, cardiorespiratory, functional capacity, quality of life and cognitive adaptations of eight weeks of water-based aerobic and combined training in elderly women previously trained for eight weeks of water-based aerobic training.
Volunteer old women age range: 60-75 years old, will participate to this study, and will randomly divided into three groups: water-based aerobic training group (WBA), water-based aerobic and combined training group (WBAC) and control group (CG).
Fifty-four elderly women volunteer will be randomly divided into two groups with ratio of 2:1 (week 0): WBA and CG. After eight weeks of intervention the WBA group will be randomly divided into two groups with ratio of 1:1 (week 9): WBA and water-based combined training (WBC).
The intervention will last 16 weeks with two weekly sessions for water-based training groups and one weekly session for CG. The WBA program will consist only of aerobic exercises while the WBC program will consist of aerobic and resistance exercises in the same session.
Participants who will be randomized for WBA group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle. In the first mesocycle (weeks 1-2), participants will carry out three 3-minute series of each exercise whose intensity corresponds 80-85% of heart rate corresponding to the anaerobic threshold (HRat). In the second mesocycle (weeks 3-4), participants will perform three 3-minute series of each exercise corresponding to 85-90% of HRat. In the third mesocycle, participants will perform three 3-minute series of each exercise at intensity corresponding to 90-95% of HRat from weeks 5-7. In the fourth mesocycle, participants will perform three 3-minute series of each exercise at intensity corresponding to 95-100% of HRat from weeks 8-10. In the fifth mesocycle (weeks 11-13) comprises three 3-minute series of each exercise whose intensity corresponds to the 100-105% of HRat for 2 minutes and <85% of HRat for 1 minute. The last mesocycle (weeks 14-16) comprises three 3-minute series of each exercise whose intensity corresponds to the 105-110% of HRat for 2 minutes and <85% of HRat for 1 minute.
Resistance training will be divide into two blocks of exercises, and each block will be compose of one exercise for the upper and one for the lower limbs. Block 1 will consist of shoulder flexion and extension (bilateral) and hip flexion and extension (unilateral) exercises. Block 2 will consist of elbow flexion and extension (bilateral) and knee flexion and extension, starting from 90° of hip flexion (unilateral), exercises. In the first mesocycle (weeks 9-10) participants will perform 2 sets of 30 s for each block with the following sequence: 30 s of exercise for the lower limb (right leg), 5 s for switching, 30 s of exercise for the lower limb (left leg), 5 s for switching and 30 s of exercise for the upper limbs. The blocks sequences and intervals will be as follows: block 1 (4 min 20s), interval between blocks (1 min) and block 2 (4 min 20 s). In the second mesocycle (weeks 11-13) participants will perform 3 sets of 20 s for each block.The blocks sequences and intervals will be as follows: 3 times block 1 (6 min 10 s), interval between blocks (1 min) and block 2 (6 min 10 s). In the third mesocycle (weeks 14-16) the participants will perform 4 sets of 15 s for each block. The blocks sequences and intervals will be as follows: 4 times block 1 (8 min 10 s), interval between blocks (1 min) and 4 times block 2 (8 min 10 s).
Assessments of muscular endurance of knee extensors and elbow flexors, peak oxygen consumption and ventilatory thresholds, occurrence of low back pain and disability from the same, functional capacity (30-second chair stand, 8-foot up-and-go and chair sit-and-reach) and of functional test 8-foot up-and-go with counting task will be performed before (week 0) and after interventions (week 17). Moreover, assessments of maximal dynamic strength in knee extensors and elbow flexors, maximal neuromuscular activity and maximal voluntary isometric contraction of knee extensor muscles, muscle thickness and echo intensity of knee extensor muscles, heart rate, blood pressure, functional capacity (6-minute walk), quality of life and cognitive function will be performed before (week 0), between (week 9) and after interventions (week 17).
The data will be analyzed using Generalized Estimating Equations (GEE) and Bonferroni post-hoc test (α=0,05).
- Conditions
- Elderly Women
- Being tested
- Water-based aerobic training, Water-based aerobic and combined training, Control group
- Keywords
- combined training, aerobic training, aquatic exercises, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-based aerobic trainingBehavioural
Participants who will be randomized for the intervention in the aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle and participants will carry out three 3-minute series of each exercise. In the first mesocycle (weeks 1-2) the intensity will correspond to 80-85% of heart rate corresponding to the anaerobic threshold (HRat). In the second mesocycle (weeks 3-4) the intensity will correspond to 85-90% of HRat. In the third mesocycle, the intensity will correspond to 90-95% of HRat from weeks 5-7. In the fourth mesocycle, the intensity will correspond to 95-100% of HRat from weeks 8-10. In the fifth mesocycle (weeks 11-13) the intensity will correspond to the 100-105% of HRat for 2 minutes and <85% of HRat for 1 minute. The last mesocycle (weeks 14-16) the intensity will correspond to the 105-110% of HRat for 2 minutes and <85% of HRat for 1 minute.
Water-based aerobic and combined trainingBehavioural
Participants who will be randomized for the intervention in the aerobic and combined training group will perform 8 weeks of aerobic training and more 8 weeks of aerobic and resistance training in same session. In aerobic training the participants will perform three 3-min series of each exercise. The intensity will correspond to 80-85% of heart rate of anaerobic threshold (HRat) (weeks 1-2), 85-90% of HRat (weeks 3-4), 90-95% of HRat (weeks 5-7), 95-100% of HRat (weeks 8-10), 100-105% for 2 min and <85% of HRat for 1 min (weeks 11-13) and 105-110% for 2 min and <85% of HRat for 1 min (weeks 14-16). Resistance training will be divide into two blocks of exercises perform each repetition at maximal effort, speed and amplitude. Participants will perform 2 sets of 30 s for each block in the first mesocycle (weeks 9-10), 3 sets of 20 s in the second mesocycle (weeks 11-13) and 4 sets of 15 s in the third mesocycle (weeks 14-16).
Control groupBehavioural
The control group will perform a weekly session composed of 30 minutes of therapeutic and playfull exercises in the aquatic environment, involving games, relaxation, massage and conversation.The participants will receive instructions to perform the movements as slowly as possible to avoid physical effort.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training | Experimental | Participants who will be randomized for the intervention in the aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle and participants will carry out three 3-minute series of each exercise. In the first mesocycle (weeks 1-2) the intensity will correspond to 80-85% of heart rate corresponding to the anaerobic threshold (HRat). In the second mesocycle (weeks 3-4) the intensity will correspond to 85-90% of HRat. In the third mesocycle, the intensity will correspond to 90-95% of HRat from weeks 5-7. In the fourth mesocycle, the intensity will correspond to 95-100% of HRat from weeks 8-10. In the fifth mesocycle (weeks 11-13) the intensity will correspond to the 100-105% of HRat for 2 minutes and <85% of HRat for 1 minute. The last mesocycle (weeks 14-16) the intensity will correspond to the 105-110% of HRat for 2 minutes and <85% of HRat for 1 minute. Receives: Behavioral: Water-based aerobic training |
| Aerobic and combined training | Experimental | Participants who will be randomized for the intervention in the aerobic and combined training group will perform 8 weeks of aerobic training and more 8 weeks of aerobic and resistance training in same session. In aerobic training the participants will perform three 3-min series of each exercise. The intensity will correspond to 80-85% of heart rate of anaerobic threshold (HRat) (weeks 1-2), 85-90% of HRat (weeks 3-4), 90-95% of HRat (weeks 5-7), 95-100% of HRat (weeks 8-10), 100-105% for 2 min and <85% of HRat for 1 min (weeks 11-13) and 105-110% for 2 min and <85% of HRat for 1 min (weeks 14-16). Resistance training will be divide into two blocks of exercises perform each repetition at maximal effort, speed and amplitude. Participants will perform 2 sets of 30 s for each block in the first mesocycle (weeks 9-10), 3 sets of 20 s in the second mesocycle (weeks 11-13) and 4 sets of 15 s in the third mesocycle (weeks 14-16). Receives: Behavioral: Water-based aerobic and combined training |
| Control group | Active comparator | The control group will perform a weekly session composed of 30 minutes of therapeutic and playfull exercises in the aquatic environment, involving games, relaxation, massage and conversation.The participants will receive instructions to perform the movements as slowly as possible to avoid physical effort. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal dynamic strength change after eight and sixteen weeks (Kg)
Maximal dynamic strenght will be evaluate sing the one-repetition maximum test (1RM) on the bilateral knee extensors and free-weight barbell bilateral elbow flexors. The 1RM value will be consider as the maximal load that could be exerted at the concentric phase for a given exercise. Subjects will be familiar with al procedures in a session one week prior to the test day. Performance time for each contraction (concentric and eccentric) will be controlled by an electronic metronome.
Measured: Baseline, 8 week and 16 week
Maximal voluntary isometric contraction of knee extensors change after eight and sixteen weeks
The curve of maximum isometric muscle strength of knee extension will be collected at the same time as the eletromiography signal by dynamometer (MIOTEC, Porto Alegre, Brasil) connected to the electromyography. The subjects will receive instruction to exert maximal strength possible as fast as was possible when extending both knees. The subjects will have three attempts at obtaining the maximal voluntary contraction (MVC) of the knee extensors, each lasting 5 s.
Measured: Baseline, 8 week and 16 week
Maximum muscular activity of vastus lateralis and rectus femoris change after eight and sixteen weeks
The maximal neuromuscular activity of agonist knee extensors muscles will be evaluate using surface electromyography (RMS values) on the vastus lateralis (VL) and rectus femoris (RF). Electrodes were positioned on the muscular belly in a bipolar configuration in parallel with the orientation of the muscle fibers, according to SENIAM project (www.seniam.org). To ensure the same electrode position in subsequent tests, the right thigh of each subject will be map out for the position of the electrode moles and small angiomas by marking on transparent paper.
Measured: Baseline, 8 week and 16 week
Muscle thickness and echo intensity of knee extensors change after eight and sixteen weeks
Echo intensity and muscle thickness measures will be performed using ultrasound equipment (TOSHIBA-Tosbee/SSA-240A, Japan), with evaluation image in B-mode. Cross-sectional images will be obtained in the muscles of rights lower limbs: vastus lateralis, vastus medialis, vastus intermedius and rectus femoris. The images will be made in the vastus lateralis, vastus intermedius and rectus femoris (midway between the edge of the lateral condyle of the femur and the tip of the greater trochanter) and in the vastus medialis (20% between the edge of the lateral condyle of the femur and the tip of the greater trochanter). To ensure the same probe position in subsequent tests, the right thigh of each subject will be map out for the position of the transductor and small angiomas by marking on transparent paper.
Measured: Baseline, 8 week and 16 week
Secondary outcomes (16)
Dynamic muscular resistance change after sixteen weeks
Dynamic muscular resistance will be evaluate during the bilateral knee extensors and free-weight barbell bilateral elbow flexors exercises using a load corresponding to 60% of the 1RM.
Measured: Baseline and 16 week
Cardiorespiratory Fitness evaluation change after sixteen weeks
Protocol on the treadmill to determine the peak oxygen uptake change (VO2peak).
Measured: Baseline and 16 week
Cardiorespiratory Fitness evaluation change after sixteen weeks
Protocol on the treadmill to determine the first ventilatory threshold.
Measured: Baseline and 16 week
Cardiorespiratory Fitness evaluation change after sixteen weeks
Protocol on the treadmill to determine the second ventilatory threshold.
Measured: Baseline and 16 week
Heart rate change after sixteen weeks
Heart rate resting.
Measured: Baseline and 16 week
Blood pressure change after sixteen weeks
Resting blood pressure
Measured: Baseline and 16 week
Functional capacity change after sixteen weeks
Tests: 30-Second Chair Stand.
Measured: Baseline and 16 week
Functional capacity change after sixteen weeks
Test: 8-Foot Up-and-Go.
Measured: Baseline and 16 week
Functional capacity change after sixteen weeks
Test: Chair sit-and-reach.
Measured: Baseline and 16 week
Functional capacity change after sixteen weeks
Test: 6-Minute Walk
Measured: Baseline and 16 week
Functional capacity change after sixteen weeks
Test: 8-Foot Up-and-Go during the dual-task condition
Measured: Baseline and 16 week
Quality of Life change after sixteen weeks (Score)
World Health Organization Quality of Life - WHOQOL-bref. Scores range from 0 to 100 (0 being the lowest score possible). Higher values represent a better outcome.
Measured: Baseline and 16 week
Quality of Life change after sixteen weeks (Score)
World Health Organization Quality of Life - WHOQOL-old. Scores can range from 24 to 120. Higher values represent better quality of life.
Measured: Baseline and 16 week
Cognitive function change after sixteen weeks (Score)
Mini mental state examination The questionnaire consists of two parts, one that covers orientation, memory and attention (21 points). The second discusses specific skills such as naming and understanding (9 points). The scores range from 0 to 30. Higher values represent a better outcome.
Measured: Baseline and 16 week
Occurrence of low back pain change after sixteen weeks (%)
Semi-structured questionnaire Percentage of occurrence of low back pain (higher values represent higher occurrence of low back pain).
Measured: Baseline and 16 week
Intensity of low back pain change after sixteen weeks (Scale)
Semi-structured questionnaire. Numerical pain scale 0 (no pain) to 10 (worst pain possible).
Measured: Baseline and 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start21 Jan 2019
- Primary completion20 Dec 2019
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elderly WomenStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Santana Pinto, Federal University of Pelotas
- Investigators
- Stephanie Pinto, Phd, Principal investigator, UFPel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892278
- Sponsor's protocol ID
- ACTIVE
- Acronym
- ACTIVE
- Status last verified
- Jan 2020
- First submitted
- 5 Mar 2019
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hafele MS, Alberton CL, Hafele V, Schaun GZ, Nunes GN, Calonego C, Castro TF, Andrade LS, Pinto SS. Water-Based Training Programs Improve Functional Capacity, Cognitive and Hemodynamic Outcomes? The ACTIVE Randomized Clinical Trial. Res Q Exerc Sport. 2023 Mar;94(1):24-34. doi: 10.1080/02701367.2021.1935433. Epub 2022 Mar 16.
PubMed 35294330Hafele MS, Alberton CL, Schaun GZ, Hafele V, Nunes GN, Andrade LS, Pinto SS. Quality of life responses after combined and aerobic water-based training programs in older women: a randomized clinical trial (ACTIVE Study). Aging Clin Exp Res. 2022 May;34(5):1123-1131. doi: 10.1007/s40520-021-02040-5. Epub 2022 Jan 13.
PubMed 35023049
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 16 Weeks of Different Water-based Training Programs on Neuromuscular, Cardiorespiratory, Functional Capacity, Quality of Life and Cognitive Function Variables in Elderly Woman: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03892278
- Acronym / sponsor ID
- ACTIVE / ACTIVE
- Conditions
- Elderly Women
- Keywords
- combined training, aerobic training, aquatic exercises, aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 27 Mar 2019 (actual)
- 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.
Purpose: Investigate neuromuscular, cardiorespiratory, functional capacity, quality of life and cognitive adaptations of eight weeks of water-based aerobic and combined training in elderly women previously trained for eight weeks of water-based aerobic training.
Materials and methods: Fifty-four elderly women volunteer will be randomly divided into two groups with ratio of 2:1 (week 0): water-based aerobic training (WBA) and control group (CG). After eight weeks of intervention the WBA group will be randomly divided into two groups with ratio of 1:1 (week 9): WBA and water-based combined training (WBC). The intervention will last 16 weeks with two weekly sessions for water-based training groups and one weekly session for CG. The WBA program will consist only of aerobic exercises while the WBC program will consist of aerobic and resistance exercises in the same session. The WBA training will be performed in the percentages of heart rate corresponding to the anaerobic threshold and the resistance training sets will be performed at maximal effort. Assessments of muscular endurance of knee extensors and elbow flexors, peak oxygen consumption and ventilatory thresholds, occurrence of low back pain and disability from the same, functional capacity (30-second chair stand, 8-foot up-and-go and chair sit-and-reach) and of functional test 8-foot up-and-go with counting task will be performed before (week 0) and after interventions (week 17). Moreover, assessments of maximal dynamic strength in knee extensors and elbow flexors, maximal neuromuscular activity and maximal voluntary isometric contraction of knee extensor muscles, muscle thickness and echo intensity of knee extensor muscles, heart rate, blood pressure, functional capacity (6-minute walk), quality of life and cognitive function will be performed before (week 0), between (week 9) and after interventions (week 17). The data will be analyzed using Generalized Estimating Equations (GEE) and Bonferroni post-hoc test (α=0,05).
Detailed description
Aging process has its own characteristics, among which the direct association with reductions in muscle mass, muscle strength and cardiorespiratory fitness are highlighted. These reductions cause impairment in functional capacity, affecting the efficiency of elderly individuals to perform daily living tasks. However regular exercise practice can be efficient to mitigate factors associated with aging.
A modality that has been well suited for individuals over 60 years is the water-based exercises training, precisely due to the beneficial conditions of the aquatic environment, such as the lower impact on the lower limbs joints in comparison to the impact observed during exercises performed on land
The aim of the study is to investigate neuromuscular, cardiorespiratory, functional capacity, quality of life and cognitive adaptations of eight weeks of water-based aerobic and combined training in elderly women previously trained for eight weeks of water-based aerobic training.
Volunteer old women age range: 60-75 years old, will participate to this study, and will randomly divided into three groups: water-based aerobic training group (WBA), water-based aerobic and combined training group (WBAC) and control group (CG).
Fifty-four elderly women volunteer will be randomly divided into two groups with ratio of 2:1 (week 0): WBA and CG. After eight weeks of intervention the WBA group will be randomly divided into two groups with ratio of 1:1 (week 9): WBA and water-based combined training (WBC).
The intervention will last 16 weeks with two weekly sessions for water-based training groups and one weekly session for CG. The WBA program will consist only of aerobic exercises while the WBC program will consist of aerobic and resistance exercises in the same session.
Participants who will be randomized for WBA group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle. In the first mesocycle (weeks 1-2), participants will carry out three 3-minute series of each exercise whose intensity corresponds 80-85% of heart rate corresponding to the anaerobic threshold (HRat). In the second mesocycle (weeks 3-4), participants will perform three 3-minute series of each exercise corresponding to 85-90% of HRat. In the third mesocycle, participants will perform three 3-minute series of each exercise at intensity corresponding to 90-95% of HRat from weeks 5-7. In the fourth mesocycle, participants will perform three 3-minute series of each exercise at intensity corresponding to 95-100% of HRat from weeks 8-10. In the fifth mesocycle (weeks 11-13) comprises three 3-minute series of each exercise whose intensity corresponds to the 100-105% of HRat for 2 minutes and <85% of HRat for 1 minute. The last mesocycle (weeks 14-16) comprises three 3-minute series of each exercise whose intensity corresponds to the 105-110% of HRat for 2 minutes and <85% of HRat for 1 minute.
Resistance training will be divide into two blocks of exercises, and each block will be compose of one exercise for the upper and one for the lower limbs. Block 1 will consist of shoulder flexion and extension (bilateral) and hip flexion and extension (unilateral) exercises. Block 2 will consist of elbow flexion and extension (bilateral) and knee flexion and extension, starting from 90° of hip flexion (unilateral), exercises. In the first mesocycle (weeks 9-10) participants will perform 2 sets of 30 s for each block with the following sequence: 30 s of exercise for the lower limb (right leg), 5 s for switching, 30 s of exercise for the lower limb (left leg), 5 s for switching and 30 s of exercise for the upper limbs. The blocks sequences and intervals will be as follows: block 1 (4 min 20s), interval between blocks (1 min) and block 2 (4 min 20 s). In the second mesocycle (weeks 11-13) participants will perform 3 sets of 20 s for each block.The blocks sequences and intervals will be as follows: 3 times block 1 (6 min 10 s), interval between blocks (1 min) and block 2 (6 min 10 s). In the third mesocycle (weeks 14-16) the participants will perform 4 sets of 15 s for each block. The blocks sequences and intervals will be as follows: 4 times block 1 (8 min 10 s), interval between blocks (1 min) and 4 times block 2 (8 min 10 s).
Assessments of muscular endurance of knee extensors and elbow flexors, peak oxygen consumption and ventilatory thresholds, occurrence of low back pain and disability from the same, functional capacity (30-second chair stand, 8-foot up-and-go and chair sit-and-reach) and of functional test 8-foot up-and-go with counting task will be performed before (week 0) and after interventions (week 17). Moreover, assessments of maximal dynamic strength in knee extensors and elbow flexors, maximal neuromuscular activity and maximal voluntary isometric contraction of knee extensor muscles, muscle thickness and echo intensity of knee extensor muscles, heart rate, blood pressure, functional capacity (6-minute walk), quality of life and cognitive function will be performed before (week 0), between (week 9) and after interventions (week 17).
The data will be analyzed using Generalized Estimating Equations (GEE) and Bonferroni post-hoc test (α=0,05).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic training | Experimental | Behavioral: Water-based aerobic trainingParticipants who will be randomized for the intervention in the aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle and participants will carry out three 3-minute series of each exercise. In the first mesocycle (weeks 1-2) the intensity will correspond to 80-85% of heart rate corresponding to the anaerobic threshold (HRat). In the second mesocycle (weeks 3-4) the intensity will correspond to 85-90% of HRat. In the third mesocycle, the intensity will correspond to 90-95% of HRat from weeks 5-7. In the fourth mesocycle, the intensity will correspond to 95-100% of HRat from weeks 8-10. In the fifth mesocycle (weeks 11-13) the intensity will correspond to the 100-105% of HRat for 2 minutes and <85% of HRat for 1 minute. The last mesocycle (weeks 14-16) the intensity will correspond to the 105-110% of HRat for 2 minutes and <85% of HRat for 1 minute. |
| Aerobic and combined training | Experimental | Behavioral: Water-based aerobic and combined trainingParticipants who will be randomized for the intervention in the aerobic and combined training group will perform 8 weeks of aerobic training and more 8 weeks of aerobic and resistance training in same session. In aerobic training the participants will perform three 3-min series of each exercise. The intensity will correspond to 80-85% of heart rate of anaerobic threshold (HRat) (weeks 1-2), 85-90% of HRat (weeks 3-4), 90-95% of HRat (weeks 5-7), 95-100% of HRat (weeks 8-10), 100-105% for 2 min and <85% of HRat for 1 min (weeks 11-13) and 105-110% for 2 min and <85% of HRat for 1 min (weeks 14-16). Resistance training will be divide into two blocks of exercises perform each repetition at maximal effort, speed and amplitude. Participants will perform 2 sets of 30 s for each block in the first mesocycle (weeks 9-10), 3 sets of 20 s in the second mesocycle (weeks 11-13) and 4 sets of 15 s in the third mesocycle (weeks 14-16). |
| Control group | Active comparator | Behavioral: Control groupThe control group will perform a weekly session composed of 30 minutes of therapeutic and playfull exercises in the aquatic environment, involving games, relaxation, massage and conversation.The participants will receive instructions to perform the movements as slowly as possible to avoid physical effort. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteer elderly women, aged between 60-75 years old who were not participating on any regular training program in the last four months
Key exclusion criteria (2 listed)
- Cardiovascular disease (except hypertension controlled by medication);
- Physical impairments for exercise diagnosed through anamnesis;
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 |
|---|---|---|
| Water-based aerobic trainingParticipants who will be randomized for the intervention in the aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle and participants will carry out three 3-minute series of each exercise. In the first mesocycle (weeks 1-2) the intensity will correspond to 80-85% of heart rate corresponding to the anaerobic threshold (HRat). In the second mesocycle (weeks 3-4) the intensity will correspond to 85-90% of HRat. In the third mesocycle, the intensity will correspond to 90-95% of HRat from weeks 5-7. In the fourth mesocycle, the intensity will correspond to 95-100% of HRat from weeks 8-10. In the fifth mesocycle (weeks 11-13) the intensity will correspond to the 100-105% of HRat for 2 minutes and <85% of HRat for 1 minute. The last mesocycle (weeks 14-16) the intensity will correspond to the 105-110% of HRat for 2 minutes and <85% of HRat for 1 minute. | Behavioural | Aerobic training |
| Water-based aerobic and combined trainingParticipants who will be randomized for the intervention in the aerobic and combined training group will perform 8 weeks of aerobic training and more 8 weeks of aerobic and resistance training in same session. In aerobic training the participants will perform three 3-min series of each exercise. The intensity will correspond to 80-85% of heart rate of anaerobic threshold (HRat) (weeks 1-2), 85-90% of HRat (weeks 3-4), 90-95% of HRat (weeks 5-7), 95-100% of HRat (weeks 8-10), 100-105% for 2 min and <85% of HRat for 1 min (weeks 11-13) and 105-110% for 2 min and <85% of HRat for 1 min (weeks 14-16). Resistance training will be divide into two blocks of exercises perform each repetition at maximal effort, speed and amplitude. Participants will perform 2 sets of 30 s for each block in the first mesocycle (weeks 9-10), 3 sets of 20 s in the second mesocycle (weeks 11-13) and 4 sets of 15 s in the third mesocycle (weeks 14-16). | Behavioural | Aerobic and combined training |
| Control groupThe control group will perform a weekly session composed of 30 minutes of therapeutic and playfull exercises in the aquatic environment, involving games, relaxation, massage and conversation.The participants will receive instructions to perform the movements as slowly as possible to avoid physical effort. | Behavioural | Control group |
Primary outcome
Maximal dynamic strength change after eight and sixteen weeks (Kg)
Time frame: Baseline, 8 week and 16 week
Maximal dynamic strenght will be evaluate sing the one-repetition maximum test (1RM) on the bilateral knee extensors and free-weight barbell bilateral elbow flexors. The 1RM value will be consider as the maximal load that could be exerted at the concentric phase for a given exercise. Subjects will be familiar with al procedures in a session one week prior to the test day. Performance time for each contraction (concentric and eccentric) will be controlled by an electronic metronome.
Maximal voluntary isometric contraction of knee extensors change after eight and sixteen weeks
Time frame: Baseline, 8 week and 16 week
The curve of maximum isometric muscle strength of knee extension will be collected at the same time as the eletromiography signal by dynamometer (MIOTEC, Porto Alegre, Brasil) connected to the electromyography. The subjects will receive instruction to exert maximal strength possible as fast as was possible when extending both knees. The subjects will have three attempts at obtaining the maximal voluntary contraction (MVC) of the knee extensors, each lasting 5 s.
Maximum muscular activity of vastus lateralis and rectus femoris change after eight and sixteen weeks
Time frame: Baseline, 8 week and 16 week
The maximal neuromuscular activity of agonist knee extensors muscles will be evaluate using surface electromyography (RMS values) on the vastus lateralis (VL) and rectus femoris (RF). Electrodes were positioned on the muscular belly in a bipolar configuration in parallel with the orientation of the muscle fibers, according to SENIAM project (www.seniam.org). To ensure the same electrode position in subsequent tests, the right thigh of each subject will be map out for the position of the electrode moles and small angiomas by marking on transparent paper.
Muscle thickness and echo intensity of knee extensors change after eight and sixteen weeks
Time frame: Baseline, 8 week and 16 week
Echo intensity and muscle thickness measures will be performed using ultrasound equipment (TOSHIBA-Tosbee/SSA-240A, Japan), with evaluation image in B-mode. Cross-sectional images will be obtained in the muscles of rights lower limbs: vastus lateralis, vastus medialis, vastus intermedius and rectus femoris. The images will be made in the vastus lateralis, vastus intermedius and rectus femoris (midway between the edge of the lateral condyle of the femur and the tip of the greater trochanter) and in the vastus medialis (20% between the edge of the lateral condyle of the femur and the tip of the greater trochanter). To ensure the same probe position in subsequent tests, the right thigh of each subject will be map out for the position of the transductor and small angiomas by marking on transparent paper.
16 secondary outcomes
Dynamic muscular resistance change after sixteen weeks
Time frame: Baseline and 16 week
Cardiorespiratory Fitness evaluation change after sixteen weeks
Time frame: Baseline and 16 week
Cardiorespiratory Fitness evaluation change after sixteen weeks
Time frame: Baseline and 16 week
Cardiorespiratory Fitness evaluation change after sixteen weeks
Time frame: Baseline and 16 week
Heart rate change after sixteen weeks
Time frame: Baseline and 16 week
Blood pressure change after sixteen weeks
Time frame: Baseline and 16 week
Functional capacity change after sixteen weeks
Time frame: Baseline and 16 week
Functional capacity change after sixteen weeks
Time frame: Baseline and 16 week
Functional capacity change after sixteen weeks
Time frame: Baseline and 16 week
Functional capacity change after sixteen weeks
Time frame: Baseline and 16 week
Functional capacity change after sixteen weeks
Time frame: Baseline and 16 week
Quality of Life change after sixteen weeks (Score)
Time frame: Baseline and 16 week
Quality of Life change after sixteen weeks (Score)
Time frame: Baseline and 16 week
Cognitive function change after sixteen weeks (Score)
Time frame: Baseline and 16 week
Occurrence of low back pain change after sixteen weeks (%)
Time frame: Baseline and 16 week
Intensity of low back pain change after sixteen weeks (Scale)
Time frame: Baseline and 16 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Derived from this study: PubMed 35294330Hafele MS, Alberton CL, Hafele V, Schaun GZ, Nunes GN, Calonego C, Castro TF, Andrade LS, Pinto SS. Water-Based Training Programs Improve Functional Capacity, Cognitive and Hemodynamic Outcomes? The ACTIVE Randomized Clinical Trial. Res Q Exerc Sport. 2023 Mar;94(1):24-34. doi: 10.1080/02701367.2021.1935433. Epub 2022 Mar 16.
- Derived from this study: PubMed 35023049Hafele MS, Alberton CL, Schaun GZ, Hafele V, Nunes GN, Andrade LS, Pinto SS. Quality of life responses after combined and aerobic water-based training programs in older women: a randomized clinical trial (ACTIVE Study). Aging Clin Exp Res. 2022 May;34(5):1123-1131. doi: 10.1007/s40520-021-02040-5. Epub 2022 Jan 13.
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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.
Stephanie Pinto, Phd principal investigator
UFPel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-based aerobic training and Water-based aerobic and combined training in people with Elderly Women, run by Federal University of Pelotas at 1 site in Brazil.
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 2 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 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal dynamic strength change after eight and sixteen weeks (Kg) (time frame: Baseline, 8 week and 16 week). 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 NCT03892278, which also lists 2 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 21 Jan 2020.