A Frailty-specific Prehabilitation Program for Mild to Moderately Frail Patients Undergoing Cardiac Surgeries/Procedures
2026년 9월 13일 업데이트: Dr. Polly Wai-Chi Li, The University of Hong Kong
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.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
144
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Polly W.C. Li
- 전화번호: 852-3917-6686
- 이메일: pwcli@hku.hk
연구 장소
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Hong Kong, 홍콩
- 모병
- School of Nursing, The University of Hong Kong
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연락하다:
- Polly W.C. Li
- 전화번호: 852-3917-6686
- 이메일: pwcli@hku.hk
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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가짜 비교기: 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.
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Functional Capacity
기간: Baseline (T0), one-day before surgery (T1), postoperative 1 month (T2) and postoperative 3 months (T3)
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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.
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Baseline (T0), one-day before surgery (T1), postoperative 1 month (T2) and postoperative 3 months (T3)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Frailty Status
기간: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3).
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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.
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Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3).
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Cardiac-specific functional status
기간: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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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.
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Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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Cardiac-specific HRQoL
기간: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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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.
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Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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Psychological distress
기간: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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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.
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Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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Biomarkers (serum albumin)
기간: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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Serum albumin (g/L) will be assayed according to standard laboratory guidelines in clinical settings
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Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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Major adverse cardiovascular and cerebral events (MACCEs) and hospital readmission rates
기간: From the time of enrollment in the study until 12 months after completing the intervention
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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.
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From the time of enrollment in the study until 12 months after completing the intervention
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Biomarker (high-sensitivity C-reactive protein [hs-CRP])
기간: Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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hs-CRP (g/L) will be assayed according to standard laboratory guidelines in clinical settings
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Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3)
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연구 기록 날짜
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연구 주요 날짜
연구 시작 (실제)
2026년 6월 4일
기본 완료 (추정된)
2027년 4월 1일
연구 완료 (추정된)
2027년 4월 7일
연구 등록 날짜
최초 제출
2026년 6월 4일
QC 기준을 충족하는 최초 제출
2026년 9월 13일
처음 게시됨 (실제)
2026년 9월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 13일
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2026년 7월 1일
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