SarcopeniaNCT04806152
Sarcopenia and Combined-modality Exercise
A study testing High intensity exercise in people with Sarcopenia, run by The University of The West Indies at 1 site in Jamaica.
Trial summary
This study examined the effects of combined-modality exercise training (resistance, endurance, flexibility and balance) on muscle mass, muscle function and physical activity in community-dwelling elderly living in Jamaica who had been characterised as having sarcopenia. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- High intensity exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteJamaica
- Study dates
- 2 May 2017to 20 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 60 years old,
- independently ambulant, with or without an assistive device
- mentally competent to give informed consent and follow exercise instructions
Who cannot join
- a history of stroke with residual disability
- a diagnosis of cancer
- neuromuscular disorders
- auto-immune disorders
- dementia
- severe arthritis rendering participation in an exercise programme difficult
- unstable cardiovascular disease which renders exercise unsafe
Trial locations and contacts
1 site in 1 country.
Jamaica1 site
UWI Solutions for Developing Countries (SODECO)
Kingston, KSA, JMAKN04
About this study
Official title: Effect of Exercise on Muscle Mass, Functional Capacity and Physical Activity in Community-dwelling Elderly With Sarcopenia in Jamaica
This study examined the effects of combined-modality exercise training (resistance, endurance, flexibility and balance) on muscle mass, muscle function and physical activity in community-dwelling elderly living in Jamaica who had been characterised as having sarcopenia.
Read the detailed description
Community-dwelling seniors aged 60 years and older were screened for muscle mass and function (grip strength and walk speed) and persons with sarcopenia were identified using the European Working Group on Sarcopenia in Older Persons (EWGSOP) algorithm for case finding (N=1344). Of the 77 seniors with sarcopenia, 38 consented to participate and were randomly allocated to receive 6 months combined-modality high intensity treadmill based exercise and a 'usual care' home exercise programme. A comparison of the effects of treatment assignment on muscle mass, function, fitness, physical activity level and disability was done. Participants in the supervised combined-modality high intensity group were required to attend sessions 3 times per week; participants in the home exercise programme were required to attend 1 supervised session at the start of their 6-month intervention. Outcomes were assessed at baseline and at the end of the 6-month intervention. Data were analysed using standard statistical parametric and non-parametric methods including repeated measures analysis of variance to determine changes in outcomes and regression to establish determinants of outcomes.
- Conditions
- Sarcopenia
- Being tested
- High intensity exercise, Usual care home exercise
- Keywords
- exercise, training
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity exerciseOther
Supervised high-intensity combined-modality exercise was administered to participants in the exercise arm for 3 times per week for 6 months. A post-exercise recovery protein drink (31g whey-based) was given within 15 minutes after each supervised exercise session.
Usual care home exerciseOther
Walking 30 minutes, chair rises and flexibility exercises for trunk and upper extremities 5 days per week
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenia and combined-modality high intensity supervised exercise training | Experimental | Participants were given Treadmill exercise training, lower extremity progressive resistance training using a Cybex leg press machine, and a 1-hour adaptive physical activity (APA) programme in which participants were required to walk for 12 minutes through an obstacle course in which they must clear 10 cm high boards, climb 3 steps and walk sideways through hula-hoops placed on the floor all the while dual-tasking i.e. waving at strategically placed signs, conversing while walking and picking up objects. Participants also performed exercises at the parallel bars which included weight-shifting from leg to leg and half-squatting; they were also guided through seated upper- and lower-limb stretching exercises for range of motion and trunk mobility. All exercise sessions were supervised by physiotherapists. For two of the weekdays on which participants did not attend supervised training, they were asked to walk for 30 minutes at home and perform the APA exercises described above. Receives: Other: High intensity exercise |
| Sarcopenia and 'usual care' unsupervised exercise | Active comparator | Participants were required to do 5-12 chair rises and also 30-minutes walking 5 days per week. Upper limb and trunk flexibility exercises were also taught. Receives: Other: Usual care home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional endurance
Distance walked in 6 minutes
Measured: 6 months
Disability
Lawton Instrumental Activities of Daily Living scale: minimum score = 0 (low function, dependent); maximum score = 8 (high function, independent). Lower scores indicate a worse outcome.
Measured: 6 months
Lower extremity (LE) functional strength
1-repetition maximum (RM) strength
Measured: 6 months
Accelerometry
weekly energy expenditure
Measured: 6 months
self-selected walk speed
speed in the timed-10-metre walk
Measured: 6 months
Appendicular lean mass index
dual energy x-ray absorptiometry (DEXA) measured appendicular lean mass summed and divided by height squared, expressed in kg/m2
Measured: 6 months
Balance
Berg balance test score: minimum score = 0, maximum score = 56. Lower values indicate worse outcome
Measured: 6 months
Fat-free mass
dual energy x-ray absorptiometry (DEXA) determined: fat mass subtracted from weight, expressed in kg
Measured: 6 months
Secondary outcomes (2)
Depression
Center for Epidemiological Studies-Depression [CES-D] score: minimum score = 0, maximum score = 60, with higher scores indicating more depressive symptoms
Measured: 6 months
Timed-up-and-go
Functional test indicating fall risk
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start2 May 2017
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Why it stopped: The COVID19 outbreak began March 2020 in Jamaica. Associated risks, prohibitive cost of mitigating those risks for study participants and locally enacted legislation militated against further recruitment and intervention activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terrence Forrester, PhD, Principal investigator, UWI Solutions for Developing CountriesMichael Boyne, MD, Principal investigator, UWI Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806152
- Sponsor's protocol ID
- UWIJAMSarc
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on Muscle Mass, Functional Capacity and Physical Activity in Community-dwelling Elderly With Sarcopenia in Jamaica
- ClinicalTrials.gov ID
- NCT04806152
- Acronym / sponsor ID
- UWIJAMSarc
- Conditions
- Sarcopenia
- Keywords
- exercise, training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The COVID19 outbreak began March 2020 in Jamaica. Associated risks, prohibitive cost of mitigating those risks for study participants and locally enacted legislation militated against further recruitment and intervention activities.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 19 Mar 2021 (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.
This study examined the effects of combined-modality exercise training (resistance, endurance, flexibility and balance) on muscle mass, muscle function and physical activity in community-dwelling elderly living in Jamaica who had been characterised as having sarcopenia.
Detailed description
Community-dwelling seniors aged 60 years and older were screened for muscle mass and function (grip strength and walk speed) and persons with sarcopenia were identified using the European Working Group on Sarcopenia in Older Persons (EWGSOP) algorithm for case finding (N=1344). Of the 77 seniors with sarcopenia, 38 consented to participate and were randomly allocated to receive 6 months combined-modality high intensity treadmill based exercise and a 'usual care' home exercise programme. A comparison of the effects of treatment assignment on muscle mass, function, fitness, physical activity level and disability was done. Participants in the supervised combined-modality high intensity group were required to attend sessions 3 times per week; participants in the home exercise programme were required to attend 1 supervised session at the start of their 6-month intervention. Outcomes were assessed at baseline and at the end of the 6-month intervention. Data were analysed using standard statistical parametric and non-parametric methods including repeated measures analysis of variance to determine changes in outcomes and regression to establish determinants of outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenia and combined-modality high intensity supervised exercise training | Experimental | Other: High intensity exerciseParticipants were given Treadmill exercise training, lower extremity progressive resistance training using a Cybex leg press machine, and a 1-hour adaptive physical activity (APA) programme in which participants were required to walk for 12 minutes through an obstacle course in which they must clear 10 cm high boards, climb 3 steps and walk sideways through hula-hoops placed on the floor all the while dual-tasking i.e. waving at strategically placed signs, conversing while walking and picking up objects. Participants also performed exercises at the parallel bars which included weight-shifting from leg to leg and half-squatting; they were also guided through seated upper- and lower-limb stretching exercises for range of motion and trunk mobility. All exercise sessions were supervised by physiotherapists. For two of the weekdays on which participants did not attend supervised training, they were asked to walk for 30 minutes at home and perform the APA exercises described above. |
| Sarcopenia and 'usual care' unsupervised exercise | Active comparator | Other: Usual care home exerciseParticipants were required to do 5-12 chair rises and also 30-minutes walking 5 days per week. Upper limb and trunk flexibility exercises were also taught. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 60 years old,
- independently ambulant, with or without an assistive device
- mentally competent to give informed consent and follow exercise instructions
Key exclusion criteria (7 listed)
- a history of stroke with residual disability
- a diagnosis of cancer
- neuromuscular disorders
- auto-immune disorders
- dementia
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 |
|---|---|---|
| High intensity exerciseSupervised high-intensity combined-modality exercise was administered to participants in the exercise arm for 3 times per week for 6 months. A post-exercise recovery protein drink (31g whey-based) was given within 15 minutes after each supervised exercise session. | Other | Sarcopenia and combined-modality high intensity supervised exercise training |
| Usual care home exerciseWalking 30 minutes, chair rises and flexibility exercises for trunk and upper extremities 5 days per week | Other | Sarcopenia and 'usual care' unsupervised exercise |
Primary outcome
Functional endurance
Time frame: 6 months
Distance walked in 6 minutes
Disability
Time frame: 6 months
Lawton Instrumental Activities of Daily Living scale: minimum score = 0 (low function, dependent); maximum score = 8 (high function, independent). Lower scores indicate a worse outcome.
Lower extremity (LE) functional strength
Time frame: 6 months
1-repetition maximum (RM) strength
Accelerometry
Time frame: 6 months
weekly energy expenditure
self-selected walk speed
Time frame: 6 months
speed in the timed-10-metre walk
Appendicular lean mass index
Time frame: 6 months
dual energy x-ray absorptiometry (DEXA) measured appendicular lean mass summed and divided by height squared, expressed in kg/m2
Balance
Time frame: 6 months
Berg balance test score: minimum score = 0, maximum score = 56. Lower values indicate worse outcome
Fat-free mass
Time frame: 6 months
dual energy x-ray absorptiometry (DEXA) determined: fat mass subtracted from weight, expressed in kg
2 secondary outcomes
Depression
Time frame: 6 months
Timed-up-and-go
Time frame: 6 months
Results and safety
The study was stopped early (reason given: The COVID19 outbreak began March 2020 in Jamaica. Associated risks, prohibitive cost of mitigating those risks for study participants and locally enacted legislation militated against further recruitment and intervention activities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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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.
Terrence Forrester, PhD principal investigator
UWI Solutions for Developing Countries
Michael Boyne, MD principal investigator
UWI Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity exercise in people with Sarcopenia, run by The University of The West Indies at 1 site in Jamaica.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 19 Mar 2021. 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 Jamaica. 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 was stopped early (reason given: The COVID19 outbreak began March 2020 in Jamaica. Associated risks, prohibitive cost of mitigating those risks for study participants and locally enacted legislation militated against further recruitment and intervention activities.). 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?
Functional endurance (time frame: 6 months). The study lists 8 primary outcomes in all. 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 19 Mar 2021.