Clinical trial NCT04806152: Sarcopenia and Combined-modality Exercise
Official title: Effect of Exercise on Muscle Mass, Functional Capacity and Physical Activity in Community-dwelling Elderly With Sarcopenia in Jamaica
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sarcopenia
Keywords: exercise
training
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 38
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional endurance
timeFrame: 6 months
measure: Disability
timeFrame: 6 months
measure: Lower extremity (LE) functional strength
timeFrame: 6 months
measure: Accelerometry
timeFrame: 6 months
measure: self-selected walk speed
timeFrame: 6 months
measure: Appendicular lean mass index
timeFrame: 6 months
measure: Balance
timeFrame: 6 months
measure: Fat-free mass
timeFrame: 6 months
Secondary outcomes:
measure: Depression
timeFrame: 6 months
measure: Timed-up-and-go
timeFrame: 6 months
Other outcomes:
Locations:
city: Kingston 7
country: Jamaica
facility: UWI Solutions for Developing Countries (SODECO)
state: KSA
Study officials:
affiliation: UWI Solutions for Developing Countries
name: Terrence Forrester, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UWI Department of Medicine
name: Michael Boyne, MD
role: PRINCIPAL_INVESTIGATOR
References: