Strength-building Lifestyle-integrated Intervention

NCT05497687 | Completed

• 1 other identifier: UW22-516
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Sarcopenia; Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

Secondary Outcomes (6)

• Muscle mass

  Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

• Muscle strength

  Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

• Cardiac-specific functional status

  Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

• Cardiac-specific health-related quality of life (HRQoL)

  Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

• Psychological distress

  Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)

Study Arms (2)

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.

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.

Interventions

Resistance exercise 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.

12-week strength-building intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The School of Nursing

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 40114426 DERIVED

MeSH Terms

Conditions

Sarcopenia; Coronary Artery Disease; Cardiovascular Diseases; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Polly Li, Dr

  The University of Hong Kong, School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masked for the study arms allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 11, 2022
• Study Start: September 22, 2022
• Primary Completion: August 31, 2023
• Study Completion: November 30, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-11

Locations

HK (1)