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.
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.
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).
Parallel
Multimodal Prehabilitation
Other interventionIn-Person Sessions: Supervised by a cancer-specialized physiotherapist. Includes: * Aerobic exercise: 20-25 min. at moderate intensity (BORG 4-6 or 60-80% HRmax). * Resistance training: 20-25 min. at 10-12 RM, using dumbbells or resistance bands. * Flexibility or balance training: 5 minutes. * Warm-up and cool-down: 5 minutes each. Sessions last 1-1.5 hours, 2-3 times/week, 15-18 sessions Education on healthy habits, smoking and alcohol cessation, sleep hygiene, and physical activity. Daily home-exercise logs and telephone supervision will support adherence. Remote Sessions: (Video call/Zoom, 45-60 min): Mixed exercises, breathing techniques, and incentive spirometry. Occupational Therapy Intervention * cognitive training (memory, attention, executive function), * upper limb functional training (fine/gross motor skills, bilateral coordination, prehension) * ADL/IADL training * energy-conservation techniques and joint-protection strategies. 6-8 sessions, 30-45 min.
Functional Capacity
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
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.
Lower Limb Strength
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
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.
Cognitive Function
Cognitive function will be evaluated using the Mini-Mental Abbreviated Test validated for Chile. The instrument assesses orientation, memory, attention, calculation, and language, with a maximum score of 35. Scores ≥30 indicate normal cognition; lower scores reflect mild to severe cognitive impairment.
Functioning and Disability
Disability will be assessed using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), a validated 36-item instrument aligned with the ICF domains. It evaluates cognition, mobility, self-care, getting along, life activities, and participation. Scores are standardized on a 0-100 scale, with higher scores indicating greater disability.
Quality of Life measured by the FACT-BMT
Health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The questionnaire includes Physical, Social/Family, Emotional, Functional Well-Being, and Bone Marrow Transplant-Specific Concerns. Total scores range from 0 to 148, with higher scores indicating better quality of life.
Feasibility: adherence, satisfaction, and adverse events
Feasibility will be assessed through: (1) adherence (percentage of prescribed sessions completed), (2) user satisfaction measured via a 9-item Likert-scale questionnaire, and (3) number and severity of adverse events reported during the intervention period.
Click on the lead sponsor to view all of their trials.
Hospital del Salvador
Lead sponsor
Universidad Católica del Maule
Collaborator
University of Chile
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
