Home-based Progressive Resistance Exercise to Enhance Physical Performance of Older Adults With Possible Sarcopenia

March 27, 2025 updated by: Dr. Pui-Hing Chau, The University of Hong Kong
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 89 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

The inclusion criteria are:

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

The exclusion criteria are:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
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
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.
Other: Waitlist control
The waitlist control participants will start the intervention 12 weeks after the baseline assessment.
Behavioral: Exercise
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in lower-limb muscle strength at 12 weeks from baseline
Time Frame: 12 weeks after baseline
Measured by Short Physical Performance Battery (SPPB), higher score indicates better performance
12 weeks after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in lower-limb muscle strength at 24 weeks from baseline
Time Frame: 24 weeks after baseline
Measured by Short Physical Performance Battery (SPPB), higher score indicates better performance
24 weeks after baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in handgrip strength at 12 weeks from baseline
Time Frame: 12 weeks after baseline
Measured by a spring-type dynamometer, higher value indicates better performance
12 weeks after baseline
Change in handgrip strength at 24 weeks from baseline
Time Frame: 24 weeks after baseline
Measured by a spring-type dynamometer, higher value indicates better performance
24 weeks after baseline
Status of possible sarcopenia at 12 weeks from baseline
Time Frame: 12 weeks after baseline
Indicated by 5-time chair stand test ≥12 second, or men and women with <28 kg and <18 kg strength
12 weeks after baseline
Status of possible sarcopenia at 24 weeks from baseline
Time Frame: 24 weeks after baseline
Indicated by 5-time chair stand test ≥12 second, or men and women with <28 kg and <18 kg strength
24 weeks after baseline
Sarcopenia risk score at 12 weeks from baseline
Time Frame: 12 weeks after baseline
Measured by SARC-CalF, which is a combination of SARC-F questionnaire and calf circumference, a cut of of >=11 indicates high risk
12 weeks after baseline
Sarcopenia risk score at 24weeks from baseline
Time Frame: 24 weeks after baseline
Measured by SARC-CalF, which is a combination of SARC-F questionnaire and calf circumference, a cut of of >=11 indicates high risk
24 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UW20-868

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect confidentiality of participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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