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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Frailty-specific prehabilitation programExperimental treatment 1 intervention
Group B: Attention placebo controlSham comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline (T0), one-day before surgery (T1), postoperative 1 month (T2) and postoperative 3 months (T3)

Secondary outcomes

1

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.

Time frame
Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3).
2

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.

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

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.

Time frame
Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
4

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.

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

Other outcomes

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