Heart FailureNCT06161402
Elastic Band-Progressive Resistance Training (EB-PRT) for Sarcopenia Among Heart Failure Patients
A study testing Elastic band-based progressive resistance training (EB-PRT) in people with Heart Failure, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Heart failure (HF) is a complicated clinical syndrome caused by structural and/or functional cardiac abnormalities that result in ineffective myocardial pumping. HF management has placed more emphasis on improving the prognostic factors which determine these poor clinical outcomes. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Elastic band-based progressive resistance training (EB-PRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 50;
- has a confirmed clinical diagnosis of HF in the electronic health record for at least 6 months to ensure adequate disease exposure;
- meeting the Asian Working Group of Sarcopenia's criteria2 [grip strength measured by dynamometer (Male: <28kg; Female: <18kg); low physical function (defined by Short Physical Performance Battery score ≤9) and reduced muscle mass by bioimpedance analysis (Inbody Technology 270; Male: appendicular skeletal muscular index (ASMI) <7.0kg/m2, Female: <5.7kg/m2)];
- has stable HF and do not have any acute respiratory and musculo-skeletal condition which contradict them from practising exercise;
- no regular resistance training for the previous 6 months.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of an Elastic Band -Based Progressive Resistance Training (EB-PRT) in Improving Sarcopenia and Clinical Outcomes Among Patients With Heart Failure: A Pilot Mixed-method Study
Heart failure (HF) is a complicated clinical syndrome caused by structural and/or functional cardiac abnormalities that result in ineffective myocardial pumping. HF management has placed more emphasis on improving the prognostic factors which determine these poor clinical outcomes. More recently, the prognostic role of sarcopenia in HF has received particular attention. Defined as progressive and generalized decline in skeletal muscle mass, strength and physical performance due to aging, sarcopenia is definitely a common comorbid of HF which follows an age-specific disease epidemiology. Given muscle disuse is the most preventable and reversible factor of sarcopenia, more evidence points to the therapeutic value of resistance training (RT) for this debilitating condition. Nevertheless, the therapeutic effects of RT on improving sarcopenia and thereby the disease prognosis among HF patients is yet to be evaluated. Therefore, the sequential mixed method study including a pilot RCT will be conducted to evaluate the preliminary effect of a 14-week elastic band-progressive resistance training (EB-PRT) and a subsequent qualitative study to explore the subjects' engagement experience. The outcomes cover the whole set of defining characteristics including muscle mass, muscle strength and functional performance and the clinical outcomes which reflect HF disease severity and patient-reported HRQL.
Read the detailed description
The aim of this study is to investigate the therapeutic value of resistant training (RT) in improving sarcopenia in heart failure patients. To better achieve such therapeutic effects, the design of RT program also needs to comply with the exercise guideline with emphasis placed on increasing the skeletal muscle mass (i.e., the key pathological factor of sarcopenia). Addressing these research agenda is crucial to inform the development of evidence-based practice to tackle the prognostic impact of sarcopenia among HF patients. This is a sequential mixed method study including a pilot RCT to evaluate the preliminary effect of a 14-week elastic band-progressive resistance training (EB-PRT) and a subsequent qualitative study to explore the subjects' engagement experience. The total study period last for 40 weeks. The sample size is 62 participants. It is a single-blinded study. The research assistants for data collection will be blinded.
For intervention group, EB-PRT is implemented during week 1-14. A purposive sample of 12 participants invited for qualitative interview during 21st -22nd week. There are 2 post-test evaluations at 14th week (T1) and 26th week (T2). After the second evaluation at week 26, the group will receive usual care with routine follow-up. For the qualitative study on, a subsample of 12 participants in intervention group will be invited to explore their experience and perception at about 21st-22th week. The interview will be semi-structured and taken about 30-40 minutes at participants' home. The control group will receive usual care including the medical care offered by the specialist out-patient clinic during 1-26 week. There are 2 post-test evaluations at 14th week (T1) and 26th week (T2). From week 27 to week 40, this wait-list control group will receive the same EB-PRT as the intervention group.
- Conditions
- Heart Failure
- Being tested
- Elastic band-based progressive resistance training (EB-PRT)
- Keywords
- Heart Failure, Sarcopenia, Resistant Training
- Medical subject headings
- Heart Failure, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic band-based progressive resistance training (EB-PRT)Behavioural
EB-PRT will be implemented during week 1-14. The EB-PRT comprises a 4-week training phase, 6-week consolidation phase and a 4-week maintenance phase.
| Study group | Role | What they receive |
|---|---|---|
| EB-PRT | Experimental | EB-PRT will implemented during week 1-14. A purposive sample of 12 participants invited for qualitative interview during 21st -22nd week. There are 2 post-test evaluations at 14th week and 26th week. After the second evaluation at week 26, the group will receive usual care with routine follow-up. Receives: Behavioral: Elastic band-based progressive resistance training (EB-PRT) |
| Usual care | No intervention | The control group will receive usual care including the medical care offered by the specialist out-patient clinic during 1-26 week. There are 2 post-test evaluations at 14th week and 26th week. From week 27 to week 40, this wait-list control group will receive the same EB-PRT as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular skeletal muscular index (ASMI)
ASMI will be measured by the bioimpedance analysis (BIA) method. Reduced muscle mass is defined if ASMI <7.0kg/m2 for male, ASMI <5.7kg/m2 for female.
Measured: Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).
Handgrip strength
Handgrip strength will be measured by a hydraulic hand dynamometer from dominant hand, taking the highest value among 3 measurements. Low muscle strength is defined if male <28kg, and femal <18kg.
Measured: Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).
Physical function
Physical function will be measured by the Short Physical Performance Battery (SPPB), which combines balance test, gait velocity and chair stand. SPPB score ranges from 0-12, higher score better physical performance. Low physical function is defined by SPPB score ≤9.
Measured: Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).
Secondary outcomes (2)
Symptom burden
Symptom burden will be measured by the Memorial Symptom Assessment Scale (MSAS-HF). The total symptom scores are summed to obtain a final grand total symptom burden score (score range of 0 to 416). Higher scores indicate greater symptom burden.
Measured: Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).
Health-Related Quality of Life (HRQL)
HRQL will be measured by the 21-item Minnesota Living with Heart Failure Questionnaire (MLHFQ), to capture the physical, emotional and social well-being. MLHFQ provides a total score (range 0-105, from best to worst HRQoL).
Measured: Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Dec 2023
- Primary completion31 Dec 2025
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Prof. Yu, Doris Sau Fung, The University of Hong Kong
- Investigators
- Doris Sau Fung YU, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161402
- Sponsor's protocol ID
- EB-PRT
- Status last verified
- Sep 2026
- First submitted
- 29 Nov 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Elastic Band -Based Progressive Resistance Training (EB-PRT) in Improving Sarcopenia and Clinical Outcomes Among Patients With Heart Failure: A Pilot Mixed-method Study
- ClinicalTrials.gov ID
- NCT06161402
- Acronym / sponsor ID
- EB-PRT
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Sarcopenia, Resistant Training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Dec 2023 (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.
Heart failure (HF) is a complicated clinical syndrome caused by structural and/or functional cardiac abnormalities that result in ineffective myocardial pumping. HF management has placed more emphasis on improving the prognostic factors which determine these poor clinical outcomes. More recently, the prognostic role of sarcopenia in HF has received particular attention. Defined as progressive and generalized decline in skeletal muscle mass, strength and physical performance due to aging, sarcopenia is definitely a common comorbid of HF which follows an age-specific disease epidemiology. Given muscle disuse is the most preventable and reversible factor of sarcopenia, more evidence points to the therapeutic value of resistance training (RT) for this debilitating condition. Nevertheless, the therapeutic effects of RT on improving sarcopenia and thereby the disease prognosis among HF patients is yet to be evaluated. Therefore, the sequential mixed method study including a pilot RCT will be conducted to evaluate the preliminary effect of a 14-week elastic band-progressive resistance training (EB-PRT) and a subsequent qualitative study to explore the subjects' engagement experience. The outcomes cover the whole set of defining characteristics including muscle mass, muscle strength and functional performance and the clinical outcomes which reflect HF disease severity and patient-reported HRQL.
Detailed description
The aim of this study is to investigate the therapeutic value of resistant training (RT) in improving sarcopenia in heart failure patients. To better achieve such therapeutic effects, the design of RT program also needs to comply with the exercise guideline with emphasis placed on increasing the skeletal muscle mass (i.e., the key pathological factor of sarcopenia). Addressing these research agenda is crucial to inform the development of evidence-based practice to tackle the prognostic impact of sarcopenia among HF patients. This is a sequential mixed method study including a pilot RCT to evaluate the preliminary effect of a 14-week elastic band-progressive resistance training (EB-PRT) and a subsequent qualitative study to explore the subjects' engagement experience. The total study period last for 40 weeks. The sample size is 62 participants. It is a single-blinded study. The research assistants for data collection will be blinded.
For intervention group, EB-PRT is implemented during week 1-14. A purposive sample of 12 participants invited for qualitative interview during 21st -22nd week. There are 2 post-test evaluations at 14th week (T1) and 26th week (T2). After the second evaluation at week 26, the group will receive usual care with routine follow-up. For the qualitative study on, a subsample of 12 participants in intervention group will be invited to explore their experience and perception at about 21st-22th week. The interview will be semi-structured and taken about 30-40 minutes at participants' home. The control group will receive usual care including the medical care offered by the specialist out-patient clinic during 1-26 week. There are 2 post-test evaluations at 14th week (T1) and 26th week (T2). From week 27 to week 40, this wait-list control group will receive the same EB-PRT as the intervention group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EB-PRT | Experimental | Behavioral: Elastic band-based progressive resistance training (EB-PRT)EB-PRT will implemented during week 1-14. A purposive sample of 12 participants invited for qualitative interview during 21st -22nd week. There are 2 post-test evaluations at 14th week and 26th week. After the second evaluation at week 26, the group will receive usual care with routine follow-up. |
| Usual care | No intervention | –The control group will receive usual care including the medical care offered by the specialist out-patient clinic during 1-26 week. There are 2 post-test evaluations at 14th week and 26th week. From week 27 to week 40, this wait-list control group will receive the same EB-PRT as the intervention group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 50;
- has a confirmed clinical diagnosis of HF in the electronic health record for at least 6 months to ensure adequate disease exposure;
- meeting the Asian Working Group of Sarcopenia's criteria2 [grip strength measured by dynamometer (Male: <28kg; Female: <18kg); low physical function (defined by Short Physical Performance Battery score ≤9) and reduced muscle mass by bioimpedance analysis (Inbody Technology 270; Male: appendicular skeletal muscular index (ASMI) <7.0kg/m2, Female: <5.7kg/m2)];
- has stable HF and do not have any acute respiratory and musculo-skeletal condition which contradict them from practising exercise;
- no regular resistance training for the previous 6 months.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Elastic band-based progressive resistance training (EB-PRT)EB-PRT will be implemented during week 1-14. The EB-PRT comprises a 4-week training phase, 6-week consolidation phase and a 4-week maintenance phase. | Behavioural | EB-PRT |
Primary outcome
Appendicular skeletal muscular index (ASMI)
Time frame: Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).
ASMI will be measured by the bioimpedance analysis (BIA) method. Reduced muscle mass is defined if ASMI <7.0kg/m2 for male, ASMI <5.7kg/m2 for female.
Handgrip strength
Time frame: Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).
Handgrip strength will be measured by a hydraulic hand dynamometer from dominant hand, taking the highest value among 3 measurements. Low muscle strength is defined if male <28kg, and femal <18kg.
Physical function
Time frame: Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).
Physical function will be measured by the Short Physical Performance Battery (SPPB), which combines balance test, gait velocity and chair stand. SPPB score ranges from 0-12, higher score better physical performance. Low physical function is defined by SPPB score ≤9.
2 secondary outcomes
Symptom burden
Time frame: Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).
Health-Related Quality of Life (HRQL)
Time frame: Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Doris Sau Fung YU, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic band-based progressive resistance training (EB-PRT) in people with Heart Failure, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appendicular skeletal muscular index (ASMI) (time frame: Changes from baseline to 14 weeks (1st post-test) and 26 weeks (2nd post-test).). The study lists 3 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 4 Sep 2026.