Sarcopenia and Combined-modality Exercise

Sponsor

The University of The West Indies (Other)

Overall Status

Terminated

CT.gov ID

NCT04806152

Collaborator

(none)

Enrollment

Location

Arms

34.6

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia	Other: High intensity exercise Other: Usual care home exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 2, 2017

Actual Primary Completion Date :

Mar 20, 2020

Actual Study Completion Date :

Mar 20, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UWI Solutions for Developing Countries (SODECO)	Kingston 7	KSA	Jamaica	JMAKN04

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of The West Indies

ClinicalTrials.gov Identifier:

NCT04806152

Other Study ID Numbers:

UWIJAMSarc

First Posted:

Mar 19, 2021

Last Update Posted:

Mar 19, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The University of The West Indies

exercise

training

Additional relevant MeSH terms:

Sarcopenia

Study Results

No Results Posted as of Mar 19, 2021