SarcopeniaSTEPNCT05570136
Functional Exercise for Sarcopenia
A study testing Functional Exercise and Education in people with Sarcopenia, run by Chang Gung Memorial Hospital at 7 sites in Taiwan.
Trial summary
Sarcopenia is one of the major causes of functional decline and negative health outcomes among older adults. Prominent evidence suggests exercise interventions can reverse sarcopenia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Functional Exercise and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 7 sitesTaiwan
- Study dates
- 15 Oct 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age 65 or older
- reside in northern Taiwan
- at risk of /with sarcopenia determined by AWGS diagnostic guidelines
Who cannot join
- meets physical activity guidelines for older adults: conduct at least 150 minutes of moderate-intensity activity or 75 minutes of vigorous-intensity activity weekly
- needs 24-hour resistance for the activity of daily living activities
- has severe knee or back pain
- severely impaired mobility or wheelchair bounded (ruling out possible secondary sarcopenia patients)
- unstable cardiac conditions such as ventricular dysrhythmias, pulmonary edema, or other musculoskeletal conditions
- impaired cognition (Mini-Mental State Examination [MMSE] score < 24, or <17 for participants with lower education level)
- has a metal clip, implant, or pacemaker
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Taiwan7 sites, 1 recruiting
- Active, not recruiting
Pei Ai holistic care association
New Taipei City, 242
- Active, not recruiting
Silver Care Association
New Taipei City
- Active, not recruiting
Chinese e-touch community service association
Taoyuan
- Active, not recruiting
Family Caregiver Care Association
Taoyuan
- Active, not recruiting
Social Service Care Association (Guishan District)
Taoyuan
- Active, not recruiting
Waishe community association
Taoyuan
- Recruiting
Zhongshan community association
Taoyuan
SHU-LING CHIU, 03-322-2617
About this study
Official title: The Effect of Functional Exercise Interventions for Older Adults With Sarcopenia: A Hybrid Approach Study Aiming for Community Implementation
Sarcopenia is one of the major causes of functional decline and negative health outcomes among older adults. Prominent evidence suggests exercise interventions can reverse sarcopenia. However, past studies mainly focus on structured exercise programs, automatically excluding many older adults who are not motivated and lack the time/resources to conduct the structural exercise. Therefore, we propose to examine the effect of the Sarcopenia Translation functional Exercise Program (the STEP program) on community-dwelling older adults. The STEP is a functional exercise program designed to address low motivation and other time/resources barriers for rapid translation in community settings. The 12-week STEP program teaches older adults to apply functional exercise activities incorporating resistant training principles in their daily routines.
With a dual focus apriori in assessing clinical effectiveness and potential implementation strategies for future community implementations, we will conduct a single-blind randomized control trial among 60 community-dwelling older adults at risk or with sarcopenia. The study's purposes are threefold: (1) to assess the effect of the functional exercise intervention compared to usual care on primary outcomes of sarcopenia (muscle strength, muscle mass, and physical function); (2) to assess the long-term effects of the functional exercise intervention on primary outcomes of sarcopenia; (3) explore potential implementation strategies for rapid community implementation including development of a communityappropriate protocol for tracking long-term effects such as metabolomic biomarkers. This study aims to develop an effective functional exercise program as an alternative to structured exercise programs. Additionally, the goal is to accelerate the translation of the functional exercise program for older adults at risk or with sarcopenia in real-world settings.
- Conditions
- Sarcopenia
- Being tested
- Functional Exercise, Education
- Keywords
- habit, community, older adult, functional exercise
- Medical subject headings
- Sarcopenia, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional ExerciseBehavioural
Treatment group will receive the 12-week STEP by a trained interventionist. During the intervention period, an occupational therapist will help the participant to learn the STEP exercise and principles and help the older adults to be more independent on functional exercising.
EducationBehavioural
In the education group, participant will receive weekly health newsletters containing general health aging materials. A staff member will call the control group participants weekly to document any new exercise programs from usual community services.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants in the treatment group will receive the 12-week STEP by a trained interventionist. In the first four weeks, the interventionist will focus on building participants' selfefficacy and health literacy and help participants learn the STEP exercise and principles. In the following four weeks, the interventionist will help the older adults to be more independent in prescribing exercise activities for themselves. In the last four weeks, participants will be fulling knowledgeable and independent on functional exercising; the interventionist will allocate community resources for long-term maintenance. After program completion, trained raters will administer at post-tests. There will also be a 3-month and 6-month follow-up evaluation after program completion. Receives: Behavioral: Functional Exercise |
| Control | Sham comparator | Participants in the control group will receive weekly health newsletters and will not get any suggestions or encouragement to do exercise from the research team. A staff member will call the control group participants weekly to document any new exercise programs from usual community services. At this stage, participants will not be excluded from the study if they join an exercise program, but we will document what kind of exercise they are conducting. Trained raters will administer at post-tests and two follow-ups. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of skeletal muscle strength in 12 weeks and 3 and 6 month follow-ups
Using a handheld dynamometer (MicroFET2, MMT) to measure the maximal isometric knee strength of the dominant leg with a standardized protocol.
Measured: From baseline to 6 month follow-up
Change of muscle mass in 12 weeks and 3 and 6 month follow-ups
Skeletal muscle mass will be measured by a portable Bio-impedance analysis (BIA) instrument at 50hz (Yida muscle mass and strength analyzer; YD01A), which had preliminary valid data for Taiwanese older adults and can be easily carried to community settings.
Measured: From baseline to 6 month follow-up
Change of physical performance in 12 weeks and 3 and 6 month follow-ups
The Short Physical Performance Battery (SPPB) is an assessment of lower extremity function with three subtests: (1) standing balance, (2) four-meter gait speed, and (3) five repetitions of sit-to-stand motion.
Measured: From baseline to 6 month follow-up
The Reach, Adoption, Adherence and Fidelity of this research.
Reach includes recruitment and retention rates. Adoption will be surveyed among participants and service networks at post-test. Adherence will be measured by the average number of activities recorded in the STEP activity planner. Fidelity is defined as treatment delivery, treatment receipt, and treatment enactment.
Measured: From baseline to 6 month follow-up
Secondary outcomes (3)
Change of exercise habit in 12 weeks and 3 and 6 month follow-ups
Self-Reported Habit Index (SRHI), a self-rated assessment, which incorporates constructs such as habit strength, frequency, relevance to self-identity, and automaticity. Higher scores indicate that behavior is more strongly habitual.
Measured: From baseline to 6 month follow-up
Change of sedentary time in 12 weeks and 3 and 6 month follow-ups
Participants will wear an ActiGraph accelerometer over the right hip on an elasticized belt for seven days after the consent visit. Participants will be asked to wear the accelerometer throughout the day except swimming, showering, or bathing.
Measured: From baseline to 6 month follow-up
Change of quality of life in 12 weeks and 3 and 6 month follow-ups
The Chinese The World Health Organization Quality of Life-Brief assessment (WHOQoL-BREF) is a validated measure that assesses physical, psychological, social relationships, and environmental quality of life.
Measured: From baseline to 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start15 Oct 2022
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment group will receive functional exercise intervention, and the sham control group will receive weekly newsletters and phone calls.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Ling Hu, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570136
- Sponsor's protocol ID
- 202201076B0
- Acronym
- STEP
- Status last verified
- Feb 2024
- First submitted
- 4 Oct 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Exercise Interventions for Older Adults With Sarcopenia: A Hybrid Approach Study Aiming for Community Implementation
- ClinicalTrials.gov ID
- NCT05570136
- Acronym / sponsor ID
- STEP / 202201076B0
- Conditions
- Sarcopenia
- Keywords
- habit, community, older adult, functional exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sarcopenia is one of the major causes of functional decline and negative health outcomes among older adults. Prominent evidence suggests exercise interventions can reverse sarcopenia. However, past studies mainly focus on structured exercise programs, automatically excluding many older adults who are not motivated and lack the time/resources to conduct the structural exercise. Therefore, we propose to examine the effect of the Sarcopenia Translation functional Exercise Program (the STEP program) on community-dwelling older adults. The STEP is a functional exercise program designed to address low motivation and other time/resources barriers for rapid translation in community settings. The 12-week STEP program teaches older adults to apply functional exercise activities incorporating resistant training principles in their daily routines.
With a dual focus apriori in assessing clinical effectiveness and potential implementation strategies for future community implementations, we will conduct a single-blind randomized control trial among 60 community-dwelling older adults at risk or with sarcopenia. The study's purposes are threefold: (1) to assess the effect of the functional exercise intervention compared to usual care on primary outcomes of sarcopenia (muscle strength, muscle mass, and physical function); (2) to assess the long-term effects of the functional exercise intervention on primary outcomes of sarcopenia; (3) explore potential implementation strategies for rapid community implementation including development of a communityappropriate protocol for tracking long-term effects such as metabolomic biomarkers. This study aims to develop an effective functional exercise program as an alternative to structured exercise programs. Additionally, the goal is to accelerate the translation of the functional exercise program for older adults at risk or with sarcopenia in real-world settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The treatment group will receive functional exercise intervention, and the sham control group will receive weekly newsletters and phone calls.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Functional ExerciseParticipants in the treatment group will receive the 12-week STEP by a trained interventionist. In the first four weeks, the interventionist will focus on building participants' selfefficacy and health literacy and help participants learn the STEP exercise and principles. In the following four weeks, the interventionist will help the older adults to be more independent in prescribing exercise activities for themselves. In the last four weeks, participants will be fulling knowledgeable and independent on functional exercising; the interventionist will allocate community resources for long-term maintenance. After program completion, trained raters will administer at post-tests. There will also be a 3-month and 6-month follow-up evaluation after program completion. |
| Control | Sham comparator | Behavioral: EducationParticipants in the control group will receive weekly health newsletters and will not get any suggestions or encouragement to do exercise from the research team. A staff member will call the control group participants weekly to document any new exercise programs from usual community services. At this stage, participants will not be excluded from the study if they join an exercise program, but we will document what kind of exercise they are conducting. Trained raters will administer at post-tests and two follow-ups. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age 65 or older
- reside in northern Taiwan
- at risk of /with sarcopenia determined by AWGS diagnostic guidelines
Key exclusion criteria (7 listed)
- meets physical activity guidelines for older adults: conduct at least 150 minutes of moderate-intensity activity or 75 minutes of vigorous-intensity activity weekly
- needs 24-hour resistance for the activity of daily living activities
- has severe knee or back pain
- severely impaired mobility or wheelchair bounded (ruling out possible secondary sarcopenia patients)
- unstable cardiac conditions such as ventricular dysrhythmias, pulmonary edema, or other musculoskeletal conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional ExerciseTreatment group will receive the 12-week STEP by a trained interventionist. During the intervention period, an occupational therapist will help the participant to learn the STEP exercise and principles and help the older adults to be more independent on functional exercising. | Behavioural | Treatment |
| EducationIn the education group, participant will receive weekly health newsletters containing general health aging materials. A staff member will call the control group participants weekly to document any new exercise programs from usual community services. | Behavioural | Control |
Primary outcome
Change of skeletal muscle strength in 12 weeks and 3 and 6 month follow-ups
Time frame: From baseline to 6 month follow-up
Using a handheld dynamometer (MicroFET2, MMT) to measure the maximal isometric knee strength of the dominant leg with a standardized protocol.
Change of muscle mass in 12 weeks and 3 and 6 month follow-ups
Time frame: From baseline to 6 month follow-up
Skeletal muscle mass will be measured by a portable Bio-impedance analysis (BIA) instrument at 50hz (Yida muscle mass and strength analyzer; YD01A), which had preliminary valid data for Taiwanese older adults and can be easily carried to community settings.
Change of physical performance in 12 weeks and 3 and 6 month follow-ups
Time frame: From baseline to 6 month follow-up
The Short Physical Performance Battery (SPPB) is an assessment of lower extremity function with three subtests: (1) standing balance, (2) four-meter gait speed, and (3) five repetitions of sit-to-stand motion.
The Reach, Adoption, Adherence and Fidelity of this research.
Time frame: From baseline to 6 month follow-up
Reach includes recruitment and retention rates. Adoption will be surveyed among participants and service networks at post-test. Adherence will be measured by the average number of activities recorded in the STEP activity planner. Fidelity is defined as treatment delivery, treatment receipt, and treatment enactment.
3 secondary outcomes
Change of exercise habit in 12 weeks and 3 and 6 month follow-ups
Time frame: From baseline to 6 month follow-up
Change of sedentary time in 12 weeks and 3 and 6 month follow-ups
Time frame: From baseline to 6 month follow-up
Change of quality of life in 12 weeks and 3 and 6 month follow-ups
Time frame: From baseline to 6 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Exercise and Education in people with Sarcopenia, run by Chang Gung Memorial Hospital at 7 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Ling Hu, Ph.D (886-3-211-8800 ext. 3057, huy@cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of skeletal muscle strength in 12 weeks and 3 and 6 month follow-ups (time frame: From baseline to 6 month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 28 Oct 2026.