A Frailty-specific Prehabilitation Program for Mild to Moderately Frail Patients Undergoing Cardiac Surgeries: A Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Functional Capacity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Patients with impaired cognition (Abbreviated Mental Test score ≤ 6) or communication, or with physical limitations affecting their ability to exercise
研究组 & 干预措施
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.
干预措施: Frailty-specific prehabilitation program (Behavioral)
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.
干预措施: A sham stretching exercise intervention (Behavioral)
结局指标
主要结局
Functional Capacity
时间窗: 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.
次要结局
- 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))
- Major adverse cardiovascular and cerebral events (MACCEs) and hospital readmission rates(From the time of enrollment in the study until 12 months after completing the intervention)
- Biomarker (high-sensitivity C-reactive protein [hs-CRP])(Baseline (T0), 1 day before surgery (T1), 1 month after surgery (T2), and 3 months after surgery (T3))
研究者
Dr. Polly Wai-Chi Li
Associate Professor
The University of Hong Kong