An interventional study of High intensity exercise and Usual care home exercise in Sarcopenia, sponsored by The University of The West Indies. Terminated at 1 site in Jamaica. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-19.
Sponsored by The University of The West Indies · Not applicable, Interventional, and Treatment
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.
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.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's enrollment of 38 is below the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →The University of The West Indies is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: High intensity exercise
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.
Other: Usual care home exercise
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
Functional endurance
Distance walked in 6 minutes
Time frame: 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.
Time frame: 6 months
Lower extremity (LE) functional strength
1-repetition maximum (RM) strength
Time frame: 6 months
Accelerometry
weekly energy expenditure
Time frame: 6 months
self-selected walk speed
speed in the timed-10-metre walk
Time frame: 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
Time frame: 6 months
Balance
Berg balance test score: minimum score = 0, maximum score = 56. Lower values indicate worse outcome
Time frame: 6 months
Fat-free mass
dual energy x-ray absorptiometry (DEXA) determined: fat mass subtracted from weight, expressed in kg
Time frame: 6 months
Depression
Center for Epidemiological Studies-Depression \[CES-D\] score: minimum score = 0, maximum score = 60, with higher scores indicating more depressive symptoms
Time frame: 6 months
Timed-up-and-go
Functional test indicating fall risk
Time frame: 6 months
Ran from May 2017 to primary completion in Mar 2020, 34 months.
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This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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The University of The West Indies