Study 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.
Sarcopenia and Combined-modality Exercise
Effect of Exercise on Muscle Mass, Functional Capacity and Physical Activity in Community-dwelling Elderly With Sarcopenia in Jamaica
1 other identifier
interventional
38
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2020
CompletedFirst Submitted
Initial submission to the registry
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 19, 2021
CompletedMarch 19, 2021
March 1, 2021
2.9 years
March 9, 2021
March 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Functional endurance
Distance walked in 6 minutes
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.
6 months
Lower extremity (LE) functional strength
1-repetition maximum (RM) strength
6 months
Accelerometry
weekly energy expenditure
6 months
self-selected walk speed
speed in the timed-10-metre walk
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
6 months
Balance
Berg balance test score: minimum score = 0, maximum score = 56. Lower values indicate worse outcome
6 months
Fat-free mass
dual energy x-ray absorptiometry (DEXA) determined: fat mass subtracted from weight, expressed in kg
6 months
Secondary Outcomes (2)
Depression
6 months
Timed-up-and-go
6 months
Study Arms (2)
Sarcopenia and combined-modality high intensity supervised exercise training
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
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.
Walking 30 minutes, chair rises and flexibility exercises for trunk and upper extremities 5 days per week
Eligibility Criteria
You may qualify if:
- over 60 years old,
- independently ambulant, with or without an assistive device
- mentally competent to give informed consent and follow exercise instructions
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UWI Solutions for Developing Countries (SODECO)
Kingston, KSA, JMAKN04, Jamaica
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terrence Forrester, PhD
UWI Solutions for Developing Countries
- PRINCIPAL INVESTIGATOR
Michael Boyne, MD
UWI Department of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2021
First Posted
March 19, 2021
Study Start
May 2, 2017
Primary Completion
March 20, 2020
Study Completion
March 20, 2020
Last Updated
March 19, 2021
Record last verified: 2021-03