Effects of a Prehabilitation Program on Frailty, Function, Quality of Life, and Post-Transplant Outcomes in Candidates for Hematopoietic Stem Cell Transplantation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Functional Capacity
研究概览
简要总结
Candidates for hematopoietic stem cell transplantation (HSCT) frequently experience declines in strength, physical function, and quality of life before the procedure. Many also present fatigue, limitations in daily activities, and an increased risk of complications during and after hospitalization. Optimizing physical condition before transplantation may improve post-procedure recovery.
This study will evaluate whether a prehabilitation program improves physical function, frailty, and quality of life in adults preparing for HSCT. The intervention consists of supervised exercise, education, and activities designed to enhance endurance and functional capacity. Although prehabilitation has shown benefits in other oncologic populations, it has been minimally studied in HSCT candidates, and no structured programs have been evaluated in Chile.
A total of 68 adults will be randomly assigned to a prehabilitation group or a usual-care control group. The prehabilitation group will receive a personalized program including aerobic and resistance exercise, stretching, balance training, respiratory exercises, and education on healthy behaviors, delivered through a hybrid model of in-person and remote sessions. Occupational therapy will also be provided to support functional and cognitive abilities. The control group will continue with standard medical care.
Baseline and post-intervention assessments will include measures of strength, frailty, fatigue, balance, cognitive function, daily activities, and quality of life. Post-transplant outcomes such as hospital length of stay, complications, and readmissions within three months will also be recorded. Feasibility, adherence, satisfaction, and adverse events will be evaluated.
Findings from this trial may inform the development of structured prehabilitation programs for HSCT candidates and support the implementation of evidence-based supportive care strategies in hematologic oncology.
详细描述
Hematopoietic stem cell transplantation (HSCT) is a complex treatment widely used for hematologic malignancies. Although it offers curative potential, many patients experience significant declines in physical functioning, increased frailty, fatigue, and reduced quality of life before and after transplantation. Lower functional reserve prior to HSCT has been associated with greater treatment-related complications, longer hospital stays, and slower recovery. Despite growing evidence supporting exercise-based interventions in cancer care, prehabilitation has been minimally studied in HSCT candidates, and no structured prehabilitation program has been tested in Chile.
This randomized clinical trial investigates whether a multimodal prehabilitation program delivered before HSCT can improve frailty, functional capacity, quality of life, and early post-transplant outcomes. The intervention combines supervised aerobic and resistance exercise, balance and flexibility training, respiratory exercises, education on healthy behaviors, and a structured home-based component. A hybrid delivery model (in-person and remote sessions) allows tailoring to individual needs and supports continuity of care. Occupational therapy sessions complement the program by addressing cognitive and functional abilities relevant to daily activities.
A total of 68 adults preparing for HSCT will be randomized in a 1:1 ratio to either the prehabilitation group or a usual-care control group. The study uses concealed allocation and blinded outcome assessment. Feasibility-including adherence, acceptability, and reported adverse events-will also be evaluated to determine whether the program can be safely and efficiently implemented in a real-world transplant setting.
The results of this trial will provide new evidence on whether prehabilitation can strengthen physical resilience before HSCT, reduce early post-transplant complications, and support better recovery. Findings may guide the development of standardized prehabilitation programs for patients undergoing HSCT and inform national recommendations for supportive care in hematologic oncology.
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)
盲法说明
Only the outcomes assessor is masked to group allocation. Participants, care providers, and investigators are not masked due to the nature of the behavioral intervention.
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
- •Adults aged ≥18 years
- •Diagnosis of hematologic malignancy requiring HSCT (autologous or allogeneic).
- •Minimum of ≥4 weeks available before the scheduled transplant.
- •"Pre-frail" or "frail" according to the HCT Frailty Scale.
- •ECOG ≤2 or Karnofsky ≥
- •Internet access (videocalls, Zoom platform, or a facilitator) for remote sessions.
排除标准
- •Cognitive impairment preventing questionnaire completion.
- •Musculoskeletal comorbidities preventing participation in supervised exercise-based prehabilitation.
- •Prior chemotherapy or radiotherapy not related to the hematologic malignancy.
- •Medical conditions limiting participation (e.g., unstable angina, arrhythmia, hypertension or heart failure, acute systemic infection with fever, acute myocarditis, or pericarditis).
结局指标
主要结局
Functional Capacity
时间窗: Baseline and post-intervention (4-6 weeks)
In the 1-minute Sit-to-Stand Test (1-min STST), participants perform repeated sit-to-stand movements for 60 seconds. The number of repetitions completed will be record. Higher scores indicate better functional capacity. The test is validated as a measure of submaximal functional endurance.
Frailty
时间窗: Baseline and immediately post-intervention (approximately 4-6 weeks).
Frailty will be assessed using the Hematopoietic Cell Transplantation-Comorbidity Index Frailty Scale (HCT Frailty Scale). The scale includes 8 items: Clinical Frailty Scale (CFS), Instrumental Activities of Daily Living (IADL), Self-Rated Health Question, Falls history, Handgrip strength, Timed Up and Go Test (TUG), serum albumin levels, and C-reactive protein (CRP). Each item is scored as normal or abnormal, yielding a total score from 0 to 10.5, with higher scores indicating greater frailty. Participants will be classified as fit, pre-frail, or frail.
Post-Transplant Outcomes
时间窗: During index hospitalization for HSCT
It includes: * Hospital length of stay: days from stem cell infusion to discharge. * Post-transplant complications (within 3 months). * Hospital readmission: number and duration of readmissions within 3 months.
Lower Limb Strength
时间窗: Baseline and post-intervention (4-6 weeks)
In the 30-second Sit-to-Stand Test (30s STST), participants are instructed to stand up and sit down from a standard chair as many times as possible within 30 seconds. The total number of completed repetitions is recorded, with higher numbers indicating better lower-limb strength. The test has demonstrated good reliability in cancer and older adult populations.
Handgrip Strength
时间窗: Baseline and post-intervention (4-6 weeks)
Handgrip strength will be assessed with the Jamar® hydraulic hand dynamometer following the American Society of Hand Therapists standardized protocol. The maximum isometric grip force (in kilograms) will be recorded. Reduced grip strength is associated with frailty and poor outcomes in cancer populations.
Fatigue
时间窗: Baseline and post-intervention (4-6 weeks)
Fatigue will be assessed using the Brief Fatigue Inventory (BFI), a validated 9-item questionnaire evaluating fatigue severity and functional interference on a 0-10 numeric scale. The instrument provides a global fatigue score, categorized as: 0 (no fatigue), 1-3 (mild), 4-6 (moderate), and 7-10 (severe). Higher scores indicate greater fatigue.
Dynamic Balance and Fall Risk
时间窗: Baseline and post-intervention (4-6 weeks)
Dynamic balance and fall risk will be assessed using the Timed Up and Go Test (TUG). Participants stand up from a chair, walk 3 meters, turn, return, and sit down. The time (in seconds) to complete the task is recorded. Faster times indicate better mobility and lower fall risk. A time ≤10 seconds is considered normal functional mobility.
Subjective physical activity level
时间窗: Baseline and post-intervention (4-6 weeks)
Physical activity levels will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The instrument records walking, moderate-intensity, and vigorous-intensity activities performed during the previous 7 days. Data are converted into metabolic equivalent minutes per week (MET-min/week). Higher scores represent higher physical activity levels.
Objective Physical Activity
时间窗: 7-day monitoring at baseline and 7-day monitoring post-intervention
It will be measured using an ActivPAL™ accelerometer, recording steps, cadence, posture, transitions, moderate-intensity activity, and sedentary behavior over 10 days.
次要结局
- Cognitive Function(Baseline and post-intervention (4-6 weeks))
- Functioning and Disability(Baseline and post-intervention (4-6 weeks))
- Quality of Life measured by the FACT-BMT(Baseline and post-intervention (4-6 weeks))
- Feasibility: adherence, satisfaction, and adverse events(Throughout the intervention period (4-6 weeks))