AgingMCvsWNCT03996083
Multicomponent Exercise vs Walking Intervention in Nursing Home Residents
A study testing Multicomponent exercise intervention and Walking intervention in people with Aging, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial summary
Physical exercise is an important tool to tackle the deleterious effect of aging. However, which is the best exercise intervention is still unknown. Moreover, many exercise interventions are complicated to implement, particularly in nursing homes. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Multicomponent exercise intervention and Walking intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2018to 1 May 2019
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Score ≥ 50 on the Barthel Index (Wade and Collin, 1988)
- ≥ 20 on the MEC-35 test (an adapted version of the Mini Mental State Examination, MMSE, validated in Spanish) (Lobo et al., 1999)
- capable to stand up and walk with or without assistive devices for at least 10 m.
- References:
- Wade D.T., Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988; 10(2):64-7. doi: 10.3109/09638288809164105.
- Lobo A, Saz P, Marcos G, Díaz J.L, de la Camara C, Ventura T, Morales Asín F, Fernando Pascual L, Montañes J.A, Aznar S. Revalidación y normali-zación del Mini-Examen Cognoscitivo (primera versión en castellano del Mini-Mental Status Exa- mination) en la población general geriátrica. Med Clin (Barc). 1999; 112; 767-774
Who cannot join
- Participants who were clinically unstable or who had any condition in which the medical staff considered it was not in the subject´s best interests to participate were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Compare a Multicomponent Exercise Program and a Walking Program in Long-term Nursing Home Residents
Physical exercise is an important tool to tackle the deleterious effect of aging. However, which is the best exercise intervention is still unknown. Moreover, many exercise interventions are complicated to implement, particularly in nursing homes. In contrast, walking is a simple, natural, and familiar mode of exercise that is well tolerated by older adults. Thus, the objective was to assess and compare the effects of an individualized multicomponent exercise program and an individualized and progressive walking intervention on LTNH residents´ physical and cognitive performance, habitual physical activity, psycho-affective status and quality of life.
Read the detailed description
The objective was to assess and compare the effects of an individualized multicomponent exercise program and an individualized and progressive walking intervention on LTNH residents´ physical and cognitive performance, habitual physical activity, psycho-affective status and quality of life.
Design: single-blind randomized controlled trial. 81 men and women were randomly assigned to a multicomponent (MG) or a walking (WG) group after baseline measurements. Participants in the MG underwent a twice a week individualised and progressive multicomponent exercise program composed of strength and balance exercises. The walking group was also individualised and walked progressively to up to 20 minutes per day for the 3-month intervention.
The primary outcome was the score on the Short Physical Performance Battery (lower limb strength (time needed to perform five chair stands), static balance (standing with feet together, semi-tandem and tandem positions) and usual gait speed (4m), assessed at baseline and after the intervention. Secondary outcomes included other relevant physical performance tests (Senior Fitness Test, the Berg Balance Scale, handgrip strength, usual gait speed (4m) the instrumented Timed Up and Go test), habitual physical activity (using accelerometers during 7 days), cognitive performance (Montreal Cognitive Assessment test and the Rey Auditory Verbal Learning Test), psycho-affective status (Anxiety and Depression Goldberg Scale, and loneliness using the Jong Gierveld loneliness scale) and quality of life (the Quality of Life Alzheimer´s disease scale). Also frailty and the number of falls and deaths will be registered.
Descriptive statistics were computed and baseline (between group differences) and time effects (within group differences) were checked using Student´s-t test (quantitative variables) or Chi square test (qualitative variables). Intervention effects between groups were assessed by 2-way analysis of variance for repeated measures (group by time interactions). Partial η2 and Cohen´s d was calculated. All the analysis performed under the intention-to-treat principle and significance was set at p < 0.05.
- Conditions
- Aging
- Being tested
- Multicomponent exercise intervention, Walking intervention
- Keywords
- aging, nursing homes, accidental falls, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exercise interventionOther
Strength exercises were focused on lower limb strengthening. Individual bilateral intensities were calculated to estimate one repetition maximum (1-RM) for the leg and arm. This test was performed on the 2nd and 7th weeks of the intervention. A gradual and progressive intensity starting at 40% 1-RM and up 70% 1-RM was used. No external loads were applied to the rest of the exercises due to their complex execution technique and subsequent risk of adverse events. In these cases, training progression was achieved through volume (number of repetitions) and execution velocity increments.
Balance exercises included standing with their feet together, semi-tandem, tandem and one-legged stand positions and moving on to dynamic exercises (circuits, stepping and so on). Difficulty was increased by reducing arm and base support and by varying the type and complexity of exercises. An individualized progression was applied to each participant based on their progress throughout the intervention.
Walking interventionOther
To comply with the walking goals, walking distance was calculated based on each participant´s performance on the 6-minute walking test and using a rule of thumb. Therefore, every participant had an itinerary to follow to comply with the minimum walking time each week. Distance rather than time was used with participants for practical reasons and the inability of most of them to measure time. Moreover, time and distance were individually adapted according to each participant´s performance on the previous week.
To ensure that participants complied with the walking goals, each of them (if they were cognitively able) was given a record sheet in which they had to write down their everyday walking routines. In addition, the caregivers were also informed about the walking routines and ensured that those participants who needed close supervision had someone to walk with and filled the sheet of those that were unable to do so.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent exercise intervention | Experimental | The multicomponent exercise program consisted of strength and balance exercises performed on two non-consecutive days per week and lasting approximately an hour per session. Strength exercises were mainly focused on lower limb strengthening. A gradual and progressive intensity starting at 40% 1-RM and up 70% 1-RM was used. As for balance exercises, the first weeks consisted of mainly less complex static balance exercises and progressed to more complex and dynamic balance exercises. These exercises included standing with their feet together, semi-tandem, tandem and one-legged stand positions and moving on to dynamic exercises (circuits, stepping and so on). Difficulty was increased by reducing arm and base support and by varying the type and complexity of exercises. An individualized progression was applied to each participant based on their progress throughout the intervention. Receives: Other: Multicomponent exercise intervention |
| Walking intervention | Experimental | Participants assigned to the walking group walked with the research staff two days per week; additionally, they walked partially supervised by LTNH staff, family members or caregivers the rest of the week. Daily walking goals were set follows: walking between 5 to 10 minutes on the first month, up to 15 minutes on the second, and finally 20 minutes per day on the third month. The final goal was to get as close as possible to the recommendations of engaging in 150 minutes of aerobic exercise per week from the World Health Organization (WHO). Participants were asked to walk as fast as they could and rest was allowed whenever needed. Walking goals were achieved in one or multiple sessions, depending on each participant´s capacities. Those participants that met the walking goals without any rest were encouraged to walk at a faster pace. Receives: Other: Walking intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery
The Short Physical Performance Battery test (SPPB). It assesses Lower extremity function: static balance, gait speed and getting in and out of a chair. The participant undertakes different tests: Side-by-side, semi-tandem and tandem stands (10 seconds); 4 meters walk test at comfortable speed and 5 quickly sit to stand from a chair without upper extremity assistance. The outcome is a score 0-12 points. A higher score means better performance
Reference:
Guralnik et al, 1994. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994; 49(2):M85-94. doi: 10.1093/geronj/49.2.M85.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Secondary outcomes (22)
Senior Fitness Test: strength of the upper extremities
Number of arm curls performed in 30 seconds
Reference:
Rikli \& Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Senior Fitness Test: strength of the lower extremities
Number of Chair-stands performed in 30 seconds
Reference:
Rikli \& Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Senior Fitness Test: flexibility
Performed test: chair sit and reach. The participant is sitting and tries to touch the toes. The distance between the fingers and the toes is measured (cm)
Reference:
Rikli \& Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Senior Fitness Test: dynamic balance
8 Foot Up and Go test: The participant from a sitting positions, gets up and walks a 4 foot distance, turns and comes back. Time is measured in seconds.
Reference:
Rikli \& Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Senior Fitness Test: aerobic capacity
Performed test: 6-minutes walking test. The participant walks during 6 minutes as fast as possible without running. The distance is measured in meters
Reference:
Rikli \& Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Measured: Measurements will be made at baseline and after the intervention (3 months)
The Berg Balance Scale
Estimates postural stability using different positions. Construct: Static balance. Scale range (total score): 0-56 (the higher, the better).
Reference:
Berg et al, 1992. Measuring balance in the elderly: validation of an instrument. Can J Publ Health. 1992; 83:S7-11
Measured: Measurements will be made at baseline and after the intervention (3 months)
Usual gait speed (4m)
The participants walks at his/her usual and comfortable pace for 4 m, time is measured in seconds.
Reference:
Bohannon et al, 1996. Walking speed: reference values and correlates for older adults. J Orthop Sports Phys Ther. 1996; 24(2):86-90. doi: 10.2519/jospt.1996.24.2.86.
Measured: Measurements will be made at baseline and after the intervention (3 months)
The instrumented Timed Up and Go test
The instrumented Timed Up and Go test, using a BTS Biomedical G-WALK triaxial accelerometer and gyroscope, to measure dynamic balance. The participant gets up from a chair, walks 3 meters at a normal pace, turns and walks back to sit down again.
Reference:
Mathias et al, 1986. Balance in elderly patients: the "get-up and go" test. Arch Phys Med Rehabil. 1986; 67(6):387-9.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Objectively measured habitual physical activity
Active and sedentary periods during everyday life recorded with an accelerometer (Actigraph GT3X model (Actigraph LLC, Pensacola, FL, USA)) that is worn on the hip with a belt for a 7 day period. The device is set to quantify the number of steps taken per day. In line with that, active-period intensities will be classified following the criteria developed by Freedson et al., 1998 as low, medium or high intensity and measured in minutes.
Reference:
Freedson et al, 1988. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998; 30(5):777-81. doi: 10.1097/00005768-199805000-00021.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Montreal Cognitive Assessment test
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, constructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.
Reference:
Coen et al, 2016.Strengths and Limitations of the MoCA for Assessing Cognitive Functioning Findings From a Large Representative Sample of Irish Older Adults. Journal of Geriatric Psychiatry and Neurology. 2016; 29(1):18-24. doi: 10.1177/0891988715598236.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Rey Auditory Verbal Learning Test
It measures learning capacity. Evaluates short- and long-term verbal learning assessing the ability to learn a list of 15 common words.
Reference:
Lezak MD, Howieson DB, Loring DW. Neuropsychological Assessment. 4th ed. New York: Oxford University Press; 2004
Measured: Measurements will be made at baseline and after the intervention (3 months)
Anxiety and Depression Goldberg Scale
It is used to assess the affective state. This questionnaire includes nine depression and nine anxiety items from the past month.
Construct: Anxiety and depression.
Scale range (Subescale score):
0-9 Anxiety (the higher, the worse). 0-9 Depression (the higher, the worse).
Reference:
Goldberg et al, 1988. Detecting anxiety and depression in general medical settings. Br Med J. 1988; 297(6653):897-9. doi:10.1136/bmj.297.6653.897.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Quality of Life Alzheimer´s disease scale
It measures the perceived quality of life, particularly, self-rated quality of life for people with cognitive impairments.
Construct: Health related quality of life. Scale range (total score): 13-52 (the higher, the better).
Reference:
Logsdon et al., 2002. Assessing quality of life in older adults with cognitive impairment. Psychosomatic Medicine. 2002;64:510-519.
Measured: Measurements will be made at baseline and after the intervention (3 months)
de Jong Gierveld loneliness scale
This questionnaire includes characteristics of the social network, background variables, personality characteristics, and evaluative aspects.
Construct: Loneliness perception. Scale range (total score): 0-11 (the higher, the worse).
Reference:
De Jong Gierveld, J. (1987). Developing and testing a model of loneliness. Journal of Personality and Social Psychology, 53(1), 119-128.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Handgrip strength
For that the participant squeezes the dynamometer with maximum isometric effort for about 5 seconds. It measures strength in kg.
Reference:
Fess, 1992. Clinical assessment recommendations. 2. Casanova JS, editor. Chicago: American Society of Hand Therapists; 1992. Grip strength; pp. 41-45.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Anthropometric measurements: Height
To measure heigt the participant stands up and distance form the top of the head to the floor is measured in cm.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Anthropometric measurements: weight
Weight in Kg is measured usind a scale
Measured: Measurements will be made at baseline and after the intervention (3 months)
Anthropometric measurements: perimeters
Hip and waist perimeters are measured (in cm) using a tape measure.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Frailty Tilburg
Tilburg Frailty index estimates frailty. Construct: Multidimensional frailty. Scale range (total score): 0-15 (the higher, the worse).
References:
Gobbens et al., 2010. The Tilburg Frailty Indicator: psychometric properties. J Am Med Dir Assoc. 11(5):344-55. doi:10.1016/j.jamda.2009.11.003.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Frailty Fried
Fried's Frailty index estimates frailty.
Construct: Frailty phenotype. Scale range (total score): 0-5 (the higher, the worse).
References:
Fried et al., 2001. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 56(3):M146-56. doi: 10.1093/gerona/56.3.M146.
Measured: Measurements will be made at baseline and after the intervention (3 months)
Falls
Number of falls will be recorded from the medical records. Record from the last year and during the intervention will be recorded
Measured: Measurements will be made at baseline and after the intervention (3 months)
Deaths
Number of deaths will be recorded during the intervention
Measured: From baseline, during the intervention (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start1 Feb 2018
- Primary completion1 Apr 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susana Gil, University of the Basque Country (UPV/EHU)
- Investigators
- Susana M Gil, MD, PhD, Principal investigator, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996083
- Sponsor's protocol ID
- 2019
- Acronym
- MCvsW
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare a Multicomponent Exercise Program and a Walking Program in Long-term Nursing Home Residents
- ClinicalTrials.gov ID
- NCT03996083
- Acronym / sponsor ID
- MCvsW / 2019
- Conditions
- Aging
- Keywords
- aging, nursing homes, accidental falls, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 24 Jun 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.
Physical exercise is an important tool to tackle the deleterious effect of aging. However, which is the best exercise intervention is still unknown. Moreover, many exercise interventions are complicated to implement, particularly in nursing homes. In contrast, walking is a simple, natural, and familiar mode of exercise that is well tolerated by older adults. Thus, the objective was to assess and compare the effects of an individualized multicomponent exercise program and an individualized and progressive walking intervention on LTNH residents´ physical and cognitive performance, habitual physical activity, psycho-affective status and quality of life.
Detailed description
The objective was to assess and compare the effects of an individualized multicomponent exercise program and an individualized and progressive walking intervention on LTNH residents´ physical and cognitive performance, habitual physical activity, psycho-affective status and quality of life.
Design: single-blind randomized controlled trial. 81 men and women were randomly assigned to a multicomponent (MG) or a walking (WG) group after baseline measurements. Participants in the MG underwent a twice a week individualised and progressive multicomponent exercise program composed of strength and balance exercises. The walking group was also individualised and walked progressively to up to 20 minutes per day for the 3-month intervention.
The primary outcome was the score on the Short Physical Performance Battery (lower limb strength (time needed to perform five chair stands), static balance (standing with feet together, semi-tandem and tandem positions) and usual gait speed (4m), assessed at baseline and after the intervention. Secondary outcomes included other relevant physical performance tests (Senior Fitness Test, the Berg Balance Scale, handgrip strength, usual gait speed (4m) the instrumented Timed Up and Go test), habitual physical activity (using accelerometers during 7 days), cognitive performance (Montreal Cognitive Assessment test and the Rey Auditory Verbal Learning Test), psycho-affective status (Anxiety and Depression Goldberg Scale, and loneliness using the Jong Gierveld loneliness scale) and quality of life (the Quality of Life Alzheimer´s disease scale). Also frailty and the number of falls and deaths will be registered.
Descriptive statistics were computed and baseline (between group differences) and time effects (within group differences) were checked using Student´s-t test (quantitative variables) or Chi square test (qualitative variables). Intervention effects between groups were assessed by 2-way analysis of variance for repeated measures (group by time interactions). Partial η2 and Cohen´s d was calculated. All the analysis performed under the intention-to-treat principle and significance was set at p < 0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent exercise intervention | Experimental | Other: Multicomponent exercise interventionThe multicomponent exercise program consisted of strength and balance exercises performed on two non-consecutive days per week and lasting approximately an hour per session. Strength exercises were mainly focused on lower limb strengthening. A gradual and progressive intensity starting at 40% 1-RM and up 70% 1-RM was used. As for balance exercises, the first weeks consisted of mainly less complex static balance exercises and progressed to more complex and dynamic balance exercises. These exercises included standing with their feet together, semi-tandem, tandem and one-legged stand positions and moving on to dynamic exercises (circuits, stepping and so on). Difficulty was increased by reducing arm and base support and by varying the type and complexity of exercises. An individualized progression was applied to each participant based on their progress throughout the intervention. |
| Walking intervention | Experimental | Other: Walking interventionParticipants assigned to the walking group walked with the research staff two days per week; additionally, they walked partially supervised by LTNH staff, family members or caregivers the rest of the week. Daily walking goals were set follows: walking between 5 to 10 minutes on the first month, up to 15 minutes on the second, and finally 20 minutes per day on the third month. The final goal was to get as close as possible to the recommendations of engaging in 150 minutes of aerobic exercise per week from the World Health Organization (WHO). Participants were asked to walk as fast as they could and rest was allowed whenever needed. Walking goals were achieved in one or multiple sessions, depending on each participant´s capacities. Those participants that met the walking goals without any rest were encouraged to walk at a faster pace. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Score ≥ 50 on the Barthel Index (Wade and Collin, 1988)
- ≥ 20 on the MEC-35 test (an adapted version of the Mini Mental State Examination, MMSE, validated in Spanish) (Lobo et al., 1999)
- capable to stand up and walk with or without assistive devices for at least 10 m.
- Wade D.T., Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988; 10(2):64-7. doi: 10.3109/09638288809164105.
- Lobo A, Saz P, Marcos G, Díaz J.L, de la Camara C, Ventura T, Morales Asín F, Fernando Pascual L, Montañes J.A, Aznar S. Revalidación y normali-zación del Mini-Examen Cognoscitivo (primera versión en castellano del Mini-Mental Status Exa- mination) en la población general geriátrica. Med Clin (Barc). 1999; 112; 767-774
Key exclusion criteria (1 listed)
- Participants who were clinically unstable or who had any condition in which the medical staff considered it was not in the subject´s best interests to participate were not included in the study.
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 |
|---|---|---|
| Multicomponent exercise interventionStrength exercises were focused on lower limb strengthening. Individual bilateral intensities were calculated to estimate one repetition maximum (1-RM) for the leg and arm. This test was performed on the 2nd and 7th weeks of the intervention. A gradual and progressive intensity starting at 40% 1-RM and up 70% 1-RM was used. No external loads were applied to the rest of the exercises due to their complex execution technique and subsequent risk of adverse events. In these cases, training progression was achieved through volume (number of repetitions) and execution velocity increments. Balance exercises included standing with their feet together, semi-tandem, tandem and one-legged stand positions and moving on to dynamic exercises (circuits, stepping and so on). Difficulty was increased by reducing arm and base support and by varying the type and complexity of exercises. An individualized progression was applied to each participant based on their progress throughout the intervention. | Other | Multicomponent exercise intervention |
| Walking interventionTo comply with the walking goals, walking distance was calculated based on each participant´s performance on the 6-minute walking test and using a rule of thumb. Therefore, every participant had an itinerary to follow to comply with the minimum walking time each week. Distance rather than time was used with participants for practical reasons and the inability of most of them to measure time. Moreover, time and distance were individually adapted according to each participant´s performance on the previous week. To ensure that participants complied with the walking goals, each of them (if they were cognitively able) was given a record sheet in which they had to write down their everyday walking routines. In addition, the caregivers were also informed about the walking routines and ensured that those participants who needed close supervision had someone to walk with and filled the sheet of those that were unable to do so. | Other | Walking intervention |
Primary outcome
Short Physical Performance Battery
Time frame: Measurements will be made at baseline and after the intervention (3 months)
The Short Physical Performance Battery test (SPPB). It assesses Lower extremity function: static balance, gait speed and getting in and out of a chair. The participant undertakes different tests: Side-by-side, semi-tandem and tandem stands (10 seconds); 4 meters walk test at comfortable speed and 5 quickly sit to stand from a chair without upper extremity assistance. The outcome is a score 0-12 points. A higher score means better performance Reference: Guralnik et al, 1994. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994; 49(2):M85-94. doi: 10.1093/geronj/49.2.M85.
22 secondary outcomes
Senior Fitness Test: strength of the upper extremities
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Senior Fitness Test: strength of the lower extremities
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Senior Fitness Test: flexibility
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Senior Fitness Test: dynamic balance
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Senior Fitness Test: aerobic capacity
Time frame: Measurements will be made at baseline and after the intervention (3 months)
The Berg Balance Scale
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Usual gait speed (4m)
Time frame: Measurements will be made at baseline and after the intervention (3 months)
The instrumented Timed Up and Go test
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Objectively measured habitual physical activity
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Montreal Cognitive Assessment test
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Rey Auditory Verbal Learning Test
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Anxiety and Depression Goldberg Scale
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Quality of Life Alzheimer´s disease scale
Time frame: Measurements will be made at baseline and after the intervention (3 months)
de Jong Gierveld loneliness scale
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Handgrip strength
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Anthropometric measurements: Height
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Anthropometric measurements: weight
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Anthropometric measurements: perimeters
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Frailty Tilburg
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Frailty Fried
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Falls
Time frame: Measurements will be made at baseline and after the intervention (3 months)
Deaths
Time frame: From baseline, during the intervention (3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
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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.
Susana M Gil, MD, PhD principal investigator
University of the Basque Country (UPV/EHU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent exercise intervention and Walking intervention in people with Aging, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
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 6 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: finished, as of the sponsor's last update on 24 Jun 2019. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Short Physical Performance Battery (time frame: Measurements will be made at baseline and after the intervention (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2019.