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

NCT07824700 | Recruiting

• 1 other identifier: 2025.526
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frailty; Thoracic Surgery

Keywords

Prehabilitation; CABG; valve repair/replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Frailty Status

  Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3).

• Cardiac-specific functional status

  Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)

• Cardiac-specific HRQoL

  Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)

• Psychological distress

  Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)

• Biomarkers (serum albumin)

  Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)

Study Arms (2)

Frailty-specific prehabilitation program

EXPERIMENTAL

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

Attention placebo control

SHAM COMPARATOR

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

Interventions

Frailty-specific prehabilitation program BEHAVIORAL

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.

Frailty-specific prehabilitation program

A sham stretching exercise intervention BEHAVIORAL

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

Attention placebo control

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Polly W.C. Li

CONTACT

852-3917-6686; pwcli@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: September 17, 2026
• Study Start: June 4, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 7, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)