Strength-building Lifestyle-integrated Intervention

NCT ID: NCT05497687

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-22
• Study Completion Date: 2023-11-30

Brief 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 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:

1. 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).

2. 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).

3. 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

Keywords

cardiovascular disease; physical activity; sarcopenia; coronary artery disease; resistance exercise; older adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

12-week strength-building intervention

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.

Group Type: EXPERIMENTAL

Resistance exercise

Intervention Type: OTHER

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.

Routine care that they currently receiving provided by their primary healthcare providers

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Resistance exercise

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Polly Wai-Chi Li

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Polly Li, Dr

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong, School of Nursing

Locations

The School of Nursing

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 40114426 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UW22-516

Identifier Type: -

Identifier Source: org_study_id