Sarcopenia and Combined-modality Exercise

Sarcopenia Clinical Trial

Official title:

Effect of Exercise on Muscle Mass, Functional Capacity and Physical Activity in Community-dwelling Elderly With Sarcopenia in Jamaica

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04806152
• Other study ID #: UWIJAMSarc
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Sarcopenia

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