A Frailty-specific Prehabilitation Program for Mild to Moderately Frail Patients Undergoing Cardiac Surgeries/Procedures

A Frailty-specific Prehabilitation Program for Mild to Moderately Frail Patients Undergoing Cardiac Surgeries: A Randomized Sham-controlled Trial

The purpose of this study is to investigate the effects of the frailty-specific prehabilitation program on functional capacity, frailty, cardiac-specific functional status, serum albumin level, high-sensitivity C-reactive protein (hs-CRP) level, HRQoL, psychological outcomes, major adverse cardiovascular and cerebral events (MACCEs), and hospital readmission rates in cardiac patients. This study tests a home-based prehabilitation program for frail older adults waiting 5+ weeks for heart surgery. Participants, aged 65+ with mild-to-moderate frailty, receive structured preoperative education, protein-rich nutrition advice, relaxation techniques for stress, and exercise training 3 times weekly via home visits, video calls, and self-practice. A control group gets sham light stretching plus usual care.

Study Overview

• Status: Recruiting
• Conditions: Frailty; Thoracic Surgery
• Intervention / Treatment: Behavioral: Frailty-specific prehabilitation program; Behavioral: A sham stretching exercise intervention

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Polly W.C. Li; Phone Number: 852-3917-6686; Email: pwcli@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • School of Nursing, The University of Hong Kong
    • Contact: Polly W.C. Li; Phone Number: 852-3917-6686; Email: pwcli@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Chinese adult patients scheduled for elective CABG, valve repair/replacement, or combined CABG and valve repair/replacement;
• Have mild-to-moderate frailty at the time of recruitment, indicated by a Clinical Frailty Scale score of 4 to 6;
• Have at least 5 weeks of procedural waiting time;
• Are physically fit for prehabilitation as assessed by the surgeon's/cardiologist's using a risk assessment checklist;
• Live with their family;
• Are able to use an electronic device with internet access (patient/family).

Exclusion Criteria:

• Patients with impaired cognition (Abbreviated Mental Test score ≤ 6) or communication, or with physical limitations affecting their ability to exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Frailty-specific prehabilitation program; A comprehensive prerehabilitation program which includes 4 components: 1) structured preoperative education; 2) nutritional optimization; 3) stress management; and 4) exercise training or usual care, respectively. The prehabilitation will last for at least 4 weeks, continuing throughout the waiting period. From Week 5 until the day of the surgery, the coach will offer support to encourage the participants to maintain self-practice by prescribing exercises that have previously been learned.	Behavioral: Frailty-specific prehabilitation program; A comprehensive prerehabilitation program which includes 4 components: 1) structured preoperative education; 2) nutritional optimization; 3) stress management; and 4) exercise training or usual care, respectively. The prehabilitation will last for at least 4 weeks, continuing throughout the waiting period. From Week 5 until the day of the surgery, the coach will offer support to encourage the participants to maintain self-practice by prescribing exercises that have previously been learned.
Sham Comparator: Attention placebo control; A sham stretching exercise intervention to neutralize the attention effects given by the intervener. The exercise protocol consists of light-intensity stretching exercises. The frequency and delivery format will be the same as the prehabilitation for the intervention group, but the duration is shortened to 30-minute per session.	Behavioral: A sham stretching exercise intervention; A sham stretching exercise intervention to neutralize the attention effects given by the intervener. The exercise protocol consists of light-intensity stretching exercise involving the upper and lower body, such as neck stretch, shoulder stretch, calf stretch and sited hamstring stretch. The frequency and delivery format will be the same as the prehabilitation for the intervention group, but the duration is shortened to 30-minute per session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Capacity	Short Physical Performance Battery (SPPB) will be used to assess lower limb functional capacity. It is well validated and has been widely adopted in clinical and research settings. It consists of three timed-tasks: standing balance, walking speed, and chair-stand. The timed results will be scaled to a score from 0 to 12, with higher scores indicating better functional capacity. A hydraulic dynamometer (Jamar) will be used to evaluate grip strength of the dominant hand by maximal isometric contraction, taking the highest reading from at least two trials.	Baseline (T0), one-day before surgery (T1), postoperative 1 month (T2) and postoperative 3 months (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty Status	The Edmonton Frail Scale (EFS) will be used to evaluate the level of frailty. It consists of nine domains with performance-based and self-reported items scored from 0 to 17, with a higher score indicating a higher level of frailty.	Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3).
Cardiac-specific functional status	The Seattle Angina Questionnaire (SAQ-7) will be used to measure cardiac-related physical functioning. It has seven items measuring three domains: physical limitation, angina frequency, and disease perception, scored on a 1-5 or 1-6 sequentially coded scale. Subscale scores are transformed to a scale of 0-100, with higher scores indicating higher levels of functioning and fewer limitations.	Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
Cardiac-specific HRQoL	The MacNew instrument will be used to measure cardiac-specific HRQoL. It has 27 items scored on a scale of 1-7, and the global score is calculated by summing the item scores, with higher scores representing better HRQoL.	Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
Psychological distress	The Patient Health Questionnaire-4 will be used to measure psychological distress. It consists of four items assessing anxiety and depression, with responses given on a 4-point Likert scale. The composite total score ranges from 0 to 12, with higher scores indicating a greater level of anxiety and depression.	Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
Biomarkers (serum albumin)	Serum albumin (g/L) will be assayed according to standard laboratory guidelines in clinical settings	Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
Major adverse cardiovascular and cerebral events (MACCEs) and hospital readmission rates	MACCEs and hospital readmission rates will be monitored from the time of enrollment in the study until 12 months after completing the intervention through the review of the medical records. MACCEs are defined as an acute myocardial infarction, stroke, heart failure, or any-cause mortality, using diagnosis codes from the International Classification of Diseases, Clinical Modification, tenth Revision.	From the time of enrollment in the study until 12 months after completing the intervention
Biomarker (high-sensitivity C-reactive protein [hs-CRP])	hs-CRP (g/L) will be assayed according to standard laboratory guidelines in clinical settings	Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 7, 2027

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: September 13, 2026
• First Posted (Actual): September 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: CABG; Prehabilitation; valve repair/replacement
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty
• Other Study ID Numbers: 2025.526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No