NCT04806152

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

2.9 years

First QC Date

March 9, 2021

Last Update Submit

March 17, 2021

Conditions

Keywords

exercisetraining

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (2)

  • Depression

    6 months

  • Timed-up-and-go

    6 months

Study Arms (2)

Sarcopenia and combined-modality high intensity supervised exercise training

EXPERIMENTAL

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

Sarcopenia and 'usual care' unsupervised exercise

ACTIVE COMPARATOR

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

Interventions

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 combined-modality high intensity supervised exercise training

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

Sarcopenia and 'usual care' unsupervised exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 60 years old,
  • independently ambulant, with or without an assistive device
  • mentally competent to give informed consent and follow exercise instructions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UWI Solutions for Developing Countries (SODECO)

Kingston, KSA, JMAKN04, Jamaica

Location

MeSH Terms

Conditions

SarcopeniaMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Terrence Forrester, PhD

    UWI Solutions for Developing Countries

    PRINCIPAL INVESTIGATOR
  • Michael Boyne, MD

    UWI Department of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 19, 2021

Study Start

May 2, 2017

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations