Sarcopenia and Combined-modality Exercise

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

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.

Study Overview

• Status: Terminated
• Conditions: Sarcopenia
• Intervention / Treatment: Other: High intensity exercise; Other: Usual care home exercise

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jamaica
  • KSA
    • Kingston 7, KSA, Jamaica, JMAKN04
      • UWI Solutions for Developing Countries (SODECO)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sarcopenia and combined-modality high intensity supervised exercise training; 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; 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.
Active Comparator: Sarcopenia and 'usual care' unsupervised 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; Walking 30 minutes, chair rises and flexibility exercises for trunk and upper extremities 5 days per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional endurance	Distance walked in 6 minutes	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.	6 months
Lower extremity (LE) functional strength	1-repetition maximum (RM) strength	6 months
Accelerometry	weekly energy expenditure	6 months
self-selected walk speed	speed in the timed-10-metre walk	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	6 months
Balance	Berg balance test score: minimum score = 0, maximum score = 56. Lower values indicate worse outcome	6 months
Fat-free mass	dual energy x-ray absorptiometry (DEXA) determined: fat mass subtracted from weight, expressed in kg	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of The West Indies
• Investigators: Principal Investigator: Terrence Forrester, PhD, UWI Solutions for Developing Countries; Principal Investigator: Michael Boyne, MD, UWI Department of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: exercise; training
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: UWIJAMSarc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No