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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04806152
Other study ID # UWIJAMSarc
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 2, 2017
Est. completion date March 20, 2020

Study information

Verified date March 2021
Source The University of The West Indies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 38
Est. completion date March 20, 2020
Est. primary completion date March 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - over 60 years old, - independently ambulant, with or without an assistive device - mentally competent to give informed consent and follow exercise instructions Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High intensity 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.
Usual care home exercise
Walking 30 minutes, chair rises and flexibility exercises for trunk and upper extremities 5 days per week

Locations

Country Name City State
Jamaica UWI Solutions for Developing Countries (SODECO) Kingston 7 KSA

Sponsors (1)

Lead Sponsor Collaborator
The University of The West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional endurance Distance walked in 6 minutes 6 months
Primary 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
Primary Lower extremity (LE) functional strength 1-repetition maximum (RM) strength 6 months
Primary Accelerometry weekly energy expenditure 6 months
Primary self-selected walk speed speed in the timed-10-metre walk 6 months
Primary 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
Primary Balance Berg balance test score: minimum score = 0, maximum score = 56. Lower values indicate worse outcome 6 months
Primary Fat-free mass dual energy x-ray absorptiometry (DEXA) determined: fat mass subtracted from weight, expressed in kg 6 months
Secondary Depression Center for Epidemiological Studies-Depression [CES-D] score: minimum score = 0, maximum score = 60, with higher scores indicating more depressive symptoms 6 months
Secondary Timed-up-and-go Functional test indicating fall risk 6 months
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