Clinical trial NCT05497687: Strength-building Lifestyle-integrated Intervention
Official title: A Strength-building Lifestyle-integrated Intervention for Tackling Double Burden of Sarcopenic Patients With Coronary Artery Disease: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Coronary Artery Disease
Keywords: cardiovascular disease
physical activity
sarcopenia
coronary artery disease
resistance exercise
older adults
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Physical performance (measured by the Short Physical Performance Battery)
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Secondary outcomes:
measure: Muscle mass
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
measure: Muscle strength
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
measure: Cardiac-specific functional status
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
measure: Cardiac-specific health-related quality of life (HRQoL)
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
measure: Psychological distress
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
measure: MACCE and hospital readmission rates
timeFrame: Changes from Baseline at the 3 months (after the intervention) and 6 months (follow-up)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The School of Nursing
Study officials:
affiliation: The University of Hong Kong, School of Nursing
name: Polly Li, Dr
role: PRINCIPAL_INVESTIGATOR
References: