SarcopeniaNCT05497687
Strength-building Lifestyle-integrated Intervention
A study testing Resistance exercise in people with Sarcopenia and Coronary Artery Disease, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to 1) develop a strength-building lifestyle-integrated intervention for sarcopenic CAD patients and to 2) examine the feasibility and 3) preliminary effects of this intervention on skeletal muscle mass, muscle strength, physical performance, cardiac-related functional status and health-related quality… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia, Coronary Artery Disease
- What is being tested?
- Resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Sep 2022to 30 Nov 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese adults with a confirmed diagnosis of coronary artery disease (CAD);
- Age ≥60 years or older;
- Presence of sarcopenia according to the diagnostic criteria defined by the Asian Working Group for Sarcopenia1: low skeletal muscle mass (measuring the appendicular skeletal muscle mass with bioelectrical impedance analysis: <7.0 kg/m2 for men and <5.7 kg/m2 for women), accompanied by low muscle strength (handgrip strength <28 kg for men and <18 kg for women);
- Free from ischemic symptoms when performing activities of daily living;
- Living in the community.
Who cannot join
- Cannot read Chinese or with impaired cognition (Abbreviated Mental Test score ≤6) or communication;
- A pacemaker or implantable cardioverter defibrillator precluding the use of bioelectrical impedance analysis for body composition assessment;
- Physical limitations precluding exercise training, with any contraindication for exercise, any terminal or unstable conditions (e.g., malignant arrhythmia, severe aortic stenosis, cancer);
- Admitted or recently completed a structured cardiac rehabilitation program within the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Strength-building Lifestyle-integrated Intervention for Tackling Double Burden of Sarcopenic Patients With Coronary Artery Disease: A Pilot Randomized Controlled Trial
This study aims to 1) develop a strength-building lifestyle-integrated intervention for sarcopenic CAD patients and to 2) examine the feasibility and 3) preliminary effects of this intervention on skeletal muscle mass, muscle strength, physical performance, cardiac-related functional status and health-related quality of life (HRQoL), psychological distress, major adverse cardiovascular and cerebral events (MACCE) and hospital readmission rates
Read the detailed description
Sarcopenia, a progressive and generalized skeletal muscle disorder characterized by accelerated loss of muscle mass and function, which is related to functional and physiological impairments.Individuals with sarcopenia are associated with profound adverse health outcomes, including increased incidents of falls and fractures, functional decline and increased all cause mortality. No study has been done to examine its effects on patients having the co-existence of sarcopenia and CAD, leaving a significant gap in the literature. Indeed, enabling this vulnerable cohort to adopt and maintain regular resistance exercise remains a great challenge. Assisting older adults to integrate exercise into daily activities can maximize the training benefits and overcome barriers to exercise, and thus improve exercise adoption and adherence. This study will include an assessor-blinded two-arm prospective pilot randomized controlled trial (RCT) and a qualitative study to determine the feasibility, acceptance and engagement experience of the participants in the strength-building lifestyle-integrated intervention with assessments measured at baseline, 3 months and 6 months after randomization. Patients will be allocated chronologically in a 1:1 ratio by using a computer-generated random sequence to determine the block size (4, 6 and 8) and respective study group allocation. Additional to the usual care provided by the primary healthcare providers (i.e. unstructured patient education on lifestyle modification without structured exercise training), the intervention group will participate in a 12-week strength-building intervention to be delivered by an exercise specialist who is required to have a Bachelor's degree in physical education, sports science, physiotherapy or equivalent, and at least 2 years of postgraduate experience.The control group will receive routine care that they currently receiving provided by their primary healthcare providers, which includes unstructured patient education on lifestyle modification. The usual care does not include structured exercise training. This study will be conducted in a patient mutual support organization Care for Your Heart. Muscle mass and strength, physical performance, cardiac-specific functional status, cardiac-specific HRQoL, psychological distress, MACCE and hospital readmission rate will be measured for outcome evaluation at baseline (T0), immediate postintervention (T1), and 3 months post-intervention (T2).Physical performance will be the primary outcome, while the remaining will be the secondary outcomes.
This study aims to 1) develop a strength-building lifestyle-integrated intervention for sarcopenic CAD patients and to 2) examine the feasibility and 3) preliminary effects of this intervention on skeletal muscle mass, muscle strength, physical performance, cardiac-related functional status and health-related quality of life (HRQoL), psychological distress, major adverse cardiovascular and cerebral events (MACCE) and hospital readmission rates.
The hypotheses for the first and third study aims are:
- Patients with sarcopenia and coronary artery disease (CAD) receiving the intervention will present with increased skeletal muscle mass and strength compared with the control group at immediate post-intervention (T1), and 3 months post-intervention (T2).
- Patients with sarcopenia and CAD receiving the intervention will present with improved physical performance, cardiac-related functional status, HRQoL and psychological distress compared to the control group at immediate postintervention (T1), and 3 months post-intervention (T2).
- Patients with sarcopenia and CAD receiving the intervention will present with a lower rate of major adverse cardiovascular and cerebral events (MACCE) and hospital readmission compared to the control group at immediate post-intervention (T1), and 3 months post-intervention (T2).
The second aim is exploratory and qualitative, thus, there is no hypothesis to be tested.
- Conditions
- Sarcopenia, Coronary Artery Disease
- Being tested
- Resistance exercise
- Keywords
- cardiovascular disease, physical activity, sarcopenia, coronary artery disease, resistance exercise, older adults
- Medical subject headings
- Sarcopenia, Coronary Artery Disease, Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseOther
The training schedule for supervised sessions (including community-based and home-based) will last for 60 minutes per session, two sessions per week. From Week 3 and 4, the exercise specialist will deliver supervised home-based training, with one in-person session via home visits and one session to be delivered remotely via an online platform (Zoom). Then the supervision will gradually tail off from Week 5 and onwards, from online supervised sessions, to unsupervised self-practice sessions. An in-person supervised home visit as a booster session will be given at Week 9, the beginning of the habituation phase. Telephone follow-ups will be arranged at Week 10 - 12 by the exercise specialist. All participants in the intervention group will be invited to take part in a qualitative interview to explore the feasibility and acceptability of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| 12-week strength-building intervention | Experimental | Participants in the intervention group will participate in a 12-week strength-building intervention comprising of face-to-face/remote sessions with telephone follow-ups. Receives: Other: Resistance exercise |
| Routine care that they currently receiving provided by their primary healthcare providers | No intervention | The control group will receive routine care that they currently receiving provided by their primary healthcare providers, which include unstructured patient education on lifestyle modification. The usual care does not include structured exercise training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical performance (measured by the Short Physical Performance Battery)
The Short Physical Performance Battery will be used to assess physical performance and is well validated and widely adopted in clinical and research settings. It is a brief performance-based assessment consisting of 3 timed-tasks, including standing balance, walking speed, and chair stand tests. The timed results will be rescaled to obtain a score ranging from 0 to 12, higher scores indicate better physical performance.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Secondary outcomes (6)
Muscle mass
The appendicular skeletal muscle mass (ASM) will be measured with the bioelectrical impedance analysis (In-Body). This is one of the gold-standard evaluation tools suggested by international guidelines for assessment of muscle mass. It is widely used in research and hospital setting for clients with sarcopenia.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Muscle strength
The muscle strength will be measured with a hydraulic dynamometer ("Jamar" Dynamometer). The standard protocol suggested by international guidelines will be followed, the maximum reading of at least 2 trials using the dominant hand in a maximum-effort isometric contraction will be recorded.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Cardiac-specific functional status
The Seattle Angina Questionnaire will be used to measure cardiac-related functional status. It has 19 items in 5 subscales: physical limitation, angina stability, angina frequency, treatment satisfaction and disease perception. It is scored on a 1-5 or 6 sequentially coded scale and subscale scores are transformed to a scale of 0-100, with higher scores indicating higher levels of functioning and fewer limitations. The Chinese version has been shown to be reliable, valid, and sensitive to clinical change.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Cardiac-specific health-related quality of life (HRQoL)
The MacNew Heart Disease Health-related Quality of Life questionnaire (MacNew) will be used to measure cardiac-specific HRQoL. It has 27 items scored on a 1-7 scale, and then global score is calculated by summing the item scores, with higher scores representing better HRQoL. The global score ranges from 1 (low HRQoL) to 7 (high HRQoL). MacNew has good internal consistency, test-retest reliability, concurrent and discriminant validity.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Psychological distress
The Patient Health Questionnaire-4 (PHQ-4) will be used to measure psychological distress. It consists of 4 items assessing anxiety and depression, to be responded on a 4-point Likert scale. The composite total score ranges from 0 to 12, higher scores indicate greater level of anxiety and depression. It has good psychometric properties.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
MACCE and hospital readmission rates
Major adverse cardiovascular and cerebral events (MACCE) and hospital readmission rates.
Measured: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start22 Sep 2022
- Primary completion31 Aug 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Polly Wai-Chi Li, The University of Hong Kong
- Investigators
- Polly Li, Dr, Principal investigator, The University of Hong Kong, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497687
- Sponsor's protocol ID
- UW22-516
- Status last verified
- Nov 2023
- First submitted
- 3 Aug 2022
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li PWC, Yu DSF, Chan NY, Chiu SH, Leung JYH, Ye EQH, Cheng MHK. Resistance-based exercise intervention for patients with coronary artery disease and sarcopenia: a pilot randomized controlled trial. Eur J Cardiovasc Nurs. 2025 Jul 21;24(5):736-745. doi: 10.1093/eurjcn/zvaf041.
PubMed 40114426
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Strength-building Lifestyle-integrated Intervention for Tackling Double Burden of Sarcopenic Patients With Coronary Artery Disease: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05497687
- Acronym / sponsor ID
- UW22-516
- Conditions
- Sarcopenia, Coronary Artery Disease
- Keywords
- cardiovascular disease, physical activity, sarcopenia, coronary artery disease, resistance exercise, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 11 Aug 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.
This study aims to 1) develop a strength-building lifestyle-integrated intervention for sarcopenic CAD patients and to 2) examine the feasibility and 3) preliminary effects of this intervention on skeletal muscle mass, muscle strength, physical performance, cardiac-related functional status and health-related quality of life (HRQoL), psychological distress, major adverse cardiovascular and cerebral events (MACCE) and hospital readmission rates
Detailed description
Sarcopenia, a progressive and generalized skeletal muscle disorder characterized by accelerated loss of muscle mass and function, which is related to functional and physiological impairments.Individuals with sarcopenia are associated with profound adverse health outcomes, including increased incidents of falls and fractures, functional decline and increased all cause mortality. No study has been done to examine its effects on patients having the co-existence of sarcopenia and CAD, leaving a significant gap in the literature. Indeed, enabling this vulnerable cohort to adopt and maintain regular resistance exercise remains a great challenge. Assisting older adults to integrate exercise into daily activities can maximize the training benefits and overcome barriers to exercise, and thus improve exercise adoption and adherence. This study will include an assessor-blinded two-arm prospective pilot randomized controlled trial (RCT) and a qualitative study to determine the feasibility, acceptance and engagement experience of the participants in the strength-building lifestyle-integrated intervention with assessments measured at baseline, 3 months and 6 months after randomization. Patients will be allocated chronologically in a 1:1 ratio by using a computer-generated random sequence to determine the block size (4, 6 and 8) and respective study group allocation. Additional to the usual care provided by the primary healthcare providers (i.e. unstructured patient education on lifestyle modification without structured exercise training), the intervention group will participate in a 12-week strength-building intervention to be delivered by an exercise specialist who is required to have a Bachelor's degree in physical education, sports science, physiotherapy or equivalent, and at least 2 years of postgraduate experience.The control group will receive routine care that they currently receiving provided by their primary healthcare providers, which includes unstructured patient education on lifestyle modification. The usual care does not include structured exercise training. This study will be conducted in a patient mutual support organization Care for Your Heart. Muscle mass and strength, physical performance, cardiac-specific functional status, cardiac-specific HRQoL, psychological distress, MACCE and hospital readmission rate will be measured for outcome evaluation at baseline (T0), immediate postintervention (T1), and 3 months post-intervention (T2).Physical performance will be the primary outcome, while the remaining will be the secondary outcomes.
This study aims to 1) develop a strength-building lifestyle-integrated intervention for sarcopenic CAD patients and to 2) examine the feasibility and 3) preliminary effects of this intervention on skeletal muscle mass, muscle strength, physical performance, cardiac-related functional status and health-related quality of life (HRQoL), psychological distress, major adverse cardiovascular and cerebral events (MACCE) and hospital readmission rates.
The hypotheses for the first and third study aims are:
- Patients with sarcopenia and coronary artery disease (CAD) receiving the intervention will present with increased skeletal muscle mass and strength compared with the control group at immediate post-intervention (T1), and 3 months post-intervention (T2).
- Patients with sarcopenia and CAD receiving the intervention will present with improved physical performance, cardiac-related functional status, HRQoL and psychological distress compared to the control group at immediate postintervention (T1), and 3 months post-intervention (T2).
- Patients with sarcopenia and CAD receiving the intervention will present with a lower rate of major adverse cardiovascular and cerebral events (MACCE) and hospital readmission compared to the control group at immediate post-intervention (T1), and 3 months post-intervention (T2).
The second aim is exploratory and qualitative, thus, there is no hypothesis to be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-week strength-building intervention | Experimental | Other: Resistance exerciseParticipants in the intervention group will participate in a 12-week strength-building intervention comprising of face-to-face/remote sessions with telephone follow-ups. |
| Routine care that they currently receiving provided by their primary healthcare providers | No intervention | –The control group will receive routine care that they currently receiving provided by their primary healthcare providers, which include unstructured patient education on lifestyle modification. The usual care does not include structured exercise training. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese adults with a confirmed diagnosis of coronary artery disease (CAD);
- Age ≥60 years or older;
- Presence of sarcopenia according to the diagnostic criteria defined by the Asian Working Group for Sarcopenia1: low skeletal muscle mass (measuring the appendicular skeletal muscle mass with bioelectrical impedance analysis: <7.0 kg/m2 for men and <5.7 kg/m2 for women), accompanied by low muscle strength (handgrip strength <28 kg for men and <18 kg for women);
- Free from ischemic symptoms when performing activities of daily living;
- Living in the community.
Key exclusion criteria (4 listed)
- Cannot read Chinese or with impaired cognition (Abbreviated Mental Test score ≤6) or communication;
- A pacemaker or implantable cardioverter defibrillator precluding the use of bioelectrical impedance analysis for body composition assessment;
- Physical limitations precluding exercise training, with any contraindication for exercise, any terminal or unstable conditions (e.g., malignant arrhythmia, severe aortic stenosis, cancer);
- Admitted or recently completed a structured cardiac rehabilitation program within the past 6 months
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 |
|---|---|---|
| Resistance exerciseThe training schedule for supervised sessions (including community-based and home-based) will last for 60 minutes per session, two sessions per week. From Week 3 and 4, the exercise specialist will deliver supervised home-based training, with one in-person session via home visits and one session to be delivered remotely via an online platform (Zoom). Then the supervision will gradually tail off from Week 5 and onwards, from online supervised sessions, to unsupervised self-practice sessions. An in-person supervised home visit as a booster session will be given at Week 9, the beginning of the habituation phase. Telephone follow-ups will be arranged at Week 10 - 12 by the exercise specialist. All participants in the intervention group will be invited to take part in a qualitative interview to explore the feasibility and acceptability of the intervention. | Other | 12-week strength-building intervention |
Primary outcome
Physical performance (measured by the Short Physical Performance Battery)
Time frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
The Short Physical Performance Battery will be used to assess physical performance and is well validated and widely adopted in clinical and research settings. It is a brief performance-based assessment consisting of 3 timed-tasks, including standing balance, walking speed, and chair stand tests. The timed results will be rescaled to obtain a score ranging from 0 to 12, higher scores indicate better physical performance.
6 secondary outcomes
Muscle mass
Time frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Muscle strength
Time frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Cardiac-specific functional status
Time frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Cardiac-specific health-related quality of life (HRQoL)
Time frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Psychological distress
Time frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
MACCE and hospital readmission rates
Time frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Derived from this study: PubMed 40114426Li PWC, Yu DSF, Chan NY, Chiu SH, Leung JYH, Ye EQH, Cheng MHK. Resistance-based exercise intervention for patients with coronary artery disease and sarcopenia: a pilot randomized controlled trial. Eur J Cardiovasc Nurs. 2025 Jul 21;24(5):736-745. doi: 10.1093/eurjcn/zvaf041.
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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.
Polly Li, Dr principal investigator
The University of Hong Kong, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise in people with Sarcopenia and Coronary Artery Disease, 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 4 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: finished, as of the sponsor's last update on 7 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical performance (measured by the Short Physical Performance Battery) (time frame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497687, which also lists 1 linked publication.
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 Dec 2023.