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NCT Number: NCT07824700

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

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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, The University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Polly W.C. Li

CONTACT

[email protected]

852-3917-6686

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Functional Capacity

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

    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.

Secondary outcomes

  1. Frailty Status

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

    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.

  2. Cardiac-specific functional status

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

    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.

  3. Cardiac-specific HRQoL

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

    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.

  4. Psychological distress

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

    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.

  5. Biomarkers (serum albumin)

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

    Serum albumin (g/L) will be assayed according to standard laboratory guidelines in clinical settings

  6. Major adverse cardiovascular and cerebral events (MACCEs) and hospital readmission rates

    Time frame: From the time of enrollment in the study until 12 months after completing the intervention

    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.

  7. Biomarker (high-sensitivity C-reactive protein [hs-CRP])

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

    hs-CRP (g/L) will be assayed according to standard laboratory guidelines in clinical settings

Study contacts

Contact information is provided by the study sponsor or research team.

Polly W.C. Li

CONTACT

[email protected]

852-3917-6686

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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