Prehabilitation to Improve Frailty, Function, and Quality of Life in Candidates for Hematopoietic Stem Cell Transplantation

NCT07255521 | Not Yet Recruiting

• 1 other identifier: hsalvador
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hematopoietic Stem Cell Transplantation (HSCT)

Keywords

Prehabilitation; Hematologic Malignancies; Frailty; Cancer-Related Frailty; Functional capacity; Physical Function; Quality of life; Post-Transplant Outcomes

Outcome Measures

Primary Outcomes (9)

• 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.

  Baseline and post-intervention (4-6 weeks)

• 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.

  Baseline and immediately post-intervention (approximately 4-6 weeks).

• 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.

  Baseline and post-intervention (4-6 weeks)

• 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.

  Baseline and post-intervention (4-6 weeks)

• Fatigue

  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.

  Baseline and post-intervention (4-6 weeks)

• Dynamic Balance and Fall Risk

  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.

  Baseline and post-intervention (4-6 weeks)

• Subjective physical activity level

  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.

  Baseline and post-intervention (4-6 weeks)

• Objective Physical Activity

  It will be measured using an ActivPAL™ accelerometer, recording steps, cadence, posture, transitions, moderate-intensity activity, and sedentary behavior over 10 days.

  7-day monitoring at baseline and 7-day monitoring post-intervention

• Post-Transplant Outcomes

  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.

  During index hospitalization for HSCT

Secondary Outcomes (4)

• 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)

Study Arms (2)

Prehabilitation Program

EXPERIMENTAL

Participants in this arm will receive a multimodal prehabilitation program that includes supervised aerobic and resistance exercise, balance and flexibility training, respiratory exercises, education on healthy lifestyle behaviors, and occupational therapy. The intervention is delivered in a hybrid format (in-person and remote), 2-3 sessions per week for 15-18 sessions in total.

Other: Multimodal Prehabilitation

Usual Care

NO INTERVENTION

Participants in this arm will receive standard medical care as determined by their clinical team. No structured prehabilitation or additional exercise-based intervention will be provided.

Interventions

Multimodal Prehabilitation OTHER

In-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.

Also known as: Exercise Intervention, Occupational Therapy Intervention

Prehabilitation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥60.
• Internet access (videocalls, Zoom platform, or a facilitator) for remote sessions.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital del Salvador: lead
• Universidad Católica del Maule: collaborator
• University of Chile: collaborator

Study Sites (2)

Hospital del Salvador

Santiago, Providencia, 8320000, Chile

Location

Hospital del Salvador

Santiago, Providencia, 8320000, Chile

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Frailty

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luz Alejandra Lorca, Master

  Hospital del Salvador

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivana Gonzales Valdivia, PT

CONTACT

+56942732848; igonzalezv@hsalvador.cl

Ivana Leao Ribeiro, PhD

CONTACT

+569 65990637; ivanaleao@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: December 26, 2025
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)