Sarcopenia and Combined-modality Exercise

NCT ID: NCT04806152

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2020-03-20

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High intensity exercise

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Usual care home exercise

Intervention Type: OTHER

Walking 30 minutes, chair rises and flexibility exercises for trunk and upper extremities 5 days per week

Interventions

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.

Intervention Type: OTHER

Usual care home exercise

Walking 30 minutes, chair rises and flexibility exercises for trunk and upper extremities 5 days per week

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of The West Indies

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terrence Forrester, PhD

Role: PRINCIPAL_INVESTIGATOR

UWI Solutions for Developing Countries

Michael Boyne, MD

Role: PRINCIPAL_INVESTIGATOR

UWI Department of Medicine

Locations

UWI Solutions for Developing Countries (SODECO)

Kingston, KSA, Jamaica

Countries

Jamaica

Other Identifiers

UWIJAMSarc

Identifier Type: -

Identifier Source: org_study_id