Sarcopenia and Combined-modality Exercise

Not Applicable

Terminated

• Conditions: Sarcopenia
• Interventions: Other: High intensity exercise; Other: Usual care home exercise

• Registration Number: NCT04806152
• Lead Sponsor: The University of The West Indies

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.

Study Timeline

• Study Start: 2017-05-02
• Primary Completion: 2020-03-20
• Study Completion: 2020-03-20
• Status Verified: 2021-03
• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-17
• Last Update Submitted: 2021-03-17
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Sarcopenia and combined-modality high intensity supervised exercise training	High intensity exercise	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.
Sarcopenia and 'usual care' unsupervised exercise	Usual care home 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.

Primary Outcome Measures

Name	Time	Method
Lower extremity (LE) functional strength	6 months	1-repetition maximum (RM) strength
Appendicular lean mass index	6 months	dual energy x-ray absorptiometry (DEXA) measured appendicular lean mass summed and divided by height squared, expressed in kg/m2
Functional endurance	6 months	Distance walked in 6 minutes
Disability	6 months	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.
Fat-free mass	6 months	dual energy x-ray absorptiometry (DEXA) determined: fat mass subtracted from weight, expressed in kg
self-selected walk speed	6 months	speed in the timed-10-metre walk
Accelerometry	6 months	weekly energy expenditure
Balance	6 months	Berg balance test score: minimum score = 0, maximum score = 56. Lower values indicate worse outcome

Secondary Outcome Measures

Name	Time	Method
Depression	6 months	Center for Epidemiological Studies-Depression \[CES-D\] score: minimum score = 0, maximum score = 60, with higher scores indicating more depressive symptoms
Timed-up-and-go	6 months	Functional test indicating fall risk

Trial Locations

Locations (1)

UWI Solutions for Developing Countries (SODECO); 🇯🇲 Kingston 7, KSA, Jamaica