NCT04851262

Brief Summary

The overall aim of the proposed project is to improve muscle strength in older adults with possible sarcopenia by promoting home-based progressive resistance exercise. The target population for health talks is community-dwelling older adults. A Three monthly home-visits and weekly phone calls will be made. A waitlist randomised controlled trial will be conducted to evaluate effectiveness, and qualitative feedback will be collected from participants. A pilot study will be conducted first.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2024

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

3.9 years

First QC Date

April 12, 2021

Last Update Submit

March 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in lower-limb muscle strength at 12 weeks from baseline

    Measured by Short Physical Performance Battery (SPPB), higher score indicates better performance

    12 weeks after baseline

Secondary Outcomes (1)

  • Change in lower-limb muscle strength at 24 weeks from baseline

    24 weeks after baseline

Other Outcomes (6)

  • Change in handgrip strength at 12 weeks from baseline

    12 weeks after baseline

  • Change in handgrip strength at 24 weeks from baseline

    24 weeks after baseline

  • Status of possible sarcopenia at 12 weeks from baseline

    12 weeks after baseline

  • +3 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention is a 12-week home-based resistance training programme with phased progression. The intervention will have three phases: (i) an initial phase focused on training the target muscle(s)/movements with minimal or no external weight; (ii) an intermediate phase targeting muscle strength with increased practice resistance; and (iii) an advanced phase targeting the further enhancement of muscle strength by challenging multiple muscle groups. Each phase will involve exercises targeting the trunk, back, hip, upper-limb and lower-limb muscles.

Behavioral: Exercise

Waitlist control

OTHER

The waitlist control participants will start the intervention 12 weeks after the baseline assessment.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

The intervention is to be taught by fitness trainer at the participants' home at the start of each phase. The exercise progression model for older adults recommended by the American College of Sports Medicine, which emphasise gradual increments in training load and systematically alter one or more programme components, will be adopted.

InterventionWaitlist control

Eligibility Criteria

Age65 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65-89;
  • Possible sarcopenia (defined by AWGS 2019);
  • No cognitive impairment (Abbreviated Mental Test score ≥8); and
  • No communication problems.

You may not qualify if:

  • having engaged in a structured exercise programme in the past 6 months or planning to do so within the intervention period;
  • mobility-limiting injury of the hands or lower limbs, surgery or hospitalisation within the intervention period;
  • contraindications such as musculoskeletal/cardiorespiratory disorders, or any advanced diseases that inhibit them from exercising.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 20, 2021

Study Start

January 1, 2021

Primary Completion

November 7, 2024

Study Completion

November 7, 2024

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

To protect confidentiality of participants.

Locations