Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05497687
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2022-08-03
Brief Title:
Strength-building Lifestyle-integrated Intervention
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
A Strength-building Lifestyle-integrated Intervention for Tackling Double Burden of Sarcopenic Patients With Coronary Artery Disease A Pilot Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 impairmentsIndividuals 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 11 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 ie 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 Bachelors degree in physical education sports science physiotherapy or equivalent and at least 2 years of postgraduate experienceThe 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 T2Physical 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None