The Feasibility and Triability of a Prehabilitation Program for Mild to Moderately Frail Patients Undergoing Cardiac Surgeries/Procedures

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to develop and evaluate a frailty-specific prehabilitation program for patients awaiting cardiac surgeries/procedures. The program aims to improve functional capacity, frailty level, cardiac-related physical functioning, health-related quality of life (HRQoL), psychological distress, major adverse cardiovascular and cerebral events (MACCE), hospital length of stay, and readmission rates. Cardiovascular disease is a leading cause of disability and morbidity globally, particularly in older adults. Frailty, a geriatric syndrome commonly seen in cardiac patients, complicates their perioperative care and leads to worse outcomes. Prehabilitation, which optimizes patients' physiological and functional capacities before surgery, has shown promise in general cardiac patients but requires a more comprehensive approach for frail individuals. This randomized controlled trial will recruit 50 Chinese adults awaiting elective cardiac surgeries/procedures in Hong Kong. Participants will be randomly assigned to either the intervention group, receiving a comprehensive prehabilitation program, or the control group, receiving routine preoperative care. Assessments will be conducted at baseline and at three postoperative time points. The findings will contribute to our understanding of the impact of frailty on postoperative outcomes and help develop strategies to improve patient care. Ultimately, this study aims to reduce healthcare burdens associated with cardiac disease-related morbidity and disability.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• A confirmed schedule for elective CABG, valve repair/replacement, or combined CABG and valve repair/replacement, or TAVI

• Mild to moderate frailty at the time of recruitment, indicated by a Clinical Frailty Scale score between 4 and 6

• At least 5 weeks of procedural waiting time

• Physically fit for prehabilitation according to the surgeon/cardiologist's endorsement on a risk-assessment checklist

• Living with family

• Using an electronic device with internet access (patient/family).

Locations
Other Locations
Hong Kong Special Administrative Region
Polly Wai Chi
RECRUITING
Hong Kong
Contact Information
Primary
Polly Li, Dr
pwcli@hku.hk
852-39176686
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 50
Treatments
Experimental: Frailty-Specific Prehabilitation Program
Participants in the frailty-specific prehabilitation program (intervention group) will participate in a comprehensive prehabilitation programme comprising the following components: 1) structured preoperative education; 2) nutritional optimization; 3) stress management; and 4) exercise training. These four components are recommended by the international association as core elements of prehabilitation to optimize cardiac patients' physical and psychological capacity to withstand the challenges of cardiac surgical procedures. The prehabilitation will last for at least 4 weeks, and it will continue throughout the preoperative period.
Placebo_comparator: Routine Preoperative Care
Participants in the control group will receive routine preoperative care provided by the clinical team, which includes unstructured patient education on the surgeries/procedures, and a brief session on the use of an incentive spirometer, breathing, and coughing exercise. Other perioperative care procedures will be implemented according to the existing clinical protocols.
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov