search
Back to results

Sarcopenia and Combined-modality Exercise

Primary Purpose

Sarcopenia

Status
Terminated
Phase
Not Applicable
Locations
Jamaica
Study Type
Interventional
Intervention
High intensity exercise
Usual care home exercise
Sponsored by
The University of The West Indies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring exercise, training

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UWI Solutions for Developing Countries (SODECO)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sarcopenia and combined-modality high intensity supervised exercise training

Sarcopenia and 'usual care' unsupervised exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Depression
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
Functional test indicating fall risk

Full Information

First Posted
March 9, 2021
Last Updated
March 17, 2021
Sponsor
The University of The West Indies
search

1. Study Identification

Unique Protocol Identification Number
NCT04806152
Brief Title
Sarcopenia and Combined-modality Exercise
Official Title
Effect of Exercise on Muscle Mass, Functional Capacity and Physical Activity in Community-dwelling Elderly With Sarcopenia in Jamaica
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
The COVID19 outbreak began March 2020 in Jamaica. Associated risks, prohibitive cost of mitigating those risks for study participants and locally enacted legislation militated against further recruitment and intervention activities.
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of The West Indies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
exercise, training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sarcopenia and combined-modality high intensity supervised exercise training
Arm Type
Experimental
Arm Description
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.
Arm Title
Sarcopenia and 'usual care' unsupervised exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
High intensity exercise
Intervention Description
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
Intervention Name(s)
Usual care home exercise
Intervention Description
Walking 30 minutes, chair rises and flexibility exercises for trunk and upper extremities 5 days per week
Primary Outcome Measure Information:
Title
Functional endurance
Description
Distance walked in 6 minutes
Time Frame
6 months
Title
Disability
Description
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.
Time Frame
6 months
Title
Lower extremity (LE) functional strength
Description
1-repetition maximum (RM) strength
Time Frame
6 months
Title
Accelerometry
Description
weekly energy expenditure
Time Frame
6 months
Title
self-selected walk speed
Description
speed in the timed-10-metre walk
Time Frame
6 months
Title
Appendicular lean mass index
Description
dual energy x-ray absorptiometry (DEXA) measured appendicular lean mass summed and divided by height squared, expressed in kg/m2
Time Frame
6 months
Title
Balance
Description
Berg balance test score: minimum score = 0, maximum score = 56. Lower values indicate worse outcome
Time Frame
6 months
Title
Fat-free mass
Description
dual energy x-ray absorptiometry (DEXA) determined: fat mass subtracted from weight, expressed in kg
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Depression
Description
Center for Epidemiological Studies-Depression [CES-D] score: minimum score = 0, maximum score = 60, with higher scores indicating more depressive symptoms
Time Frame
6 months
Title
Timed-up-and-go
Description
Functional test indicating fall risk
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrence Forrester, PhD
Organizational Affiliation
UWI Solutions for Developing Countries
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Boyne, MD
Organizational Affiliation
UWI Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UWI Solutions for Developing Countries (SODECO)
City
Kingston 7
State/Province
KSA
ZIP/Postal Code
JMAKN04
Country
Jamaica

12. IPD Sharing Statement

Learn more about this trial

Sarcopenia and Combined-modality Exercise

We'll reach out to this number within 24 hrs