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Hematopoietic Stem Cell Transplantation (HSCT)PREHAB-HSCTNCT07255521

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

A study testing Multimodal Prehabilitation in people with Hematopoietic Stem Cell Transplantation (HSCT), run by Hospital del Salvador at 2 sites in Chile.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Multimodal Prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
2 sitesChile
Study dates
26 Dec 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ivana Gonzales Valdivia, PT contact

+56942732848

igonzalezv@hsalvador.cl

Ivana Leao Ribeiro, PhD contact

+569 65990637

ivanaleao@gmail.com

Chile2 sites
  • Hospital del Salvador

    Santiago, Providencia, 8320000

  • Hospital del Salvador

    Santiago, Providencia, 8320000

    Luz Alejandra Lorca, MSc, +569 82092139, llorca@hsalvador.cl

    Luz Alejandra Lorca, MSc, +569 82092139, alejandralorcap@gmail.com

Other trials in Chile

About this study

Official title: 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

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.

Read more

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.

Read the detailed description

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.

Being tested
Multimodal Prehabilitation
Keywords
Prehabilitation, Hematologic Malignancies, Frailty, Cancer-Related Frailty, Functional capacity, Physical Function, Quality of life, Post-Transplant Outcomes
Medical subject headings
Hematologic Neoplasms, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal PrehabilitationOther

    Also called Exercise Intervention, Occupational Therapy Intervention

    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.
Study groups in NCT07255521
Study groupRoleWhat they receive
Prehabilitation ProgramExperimentalParticipants 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.
Receives: Other: Multimodal Prehabilitation
Usual CareNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and post-intervention (4-6 weeks)

  2. 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.

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

  3. 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.

    Measured: Baseline and post-intervention (4-6 weeks)

  4. 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.

    Measured: Baseline and post-intervention (4-6 weeks)

  5. 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.

    Measured: Baseline and post-intervention (4-6 weeks)

  6. 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.

    Measured: Baseline and post-intervention (4-6 weeks)

  7. 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.

    Measured: Baseline and post-intervention (4-6 weeks)

  8. 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.

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

  9. 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.

    Measured: During index hospitalization for HSCT

Secondary outcomes (4)
  1. 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.

    Measured: Baseline and post-intervention (4-6 weeks)

  2. 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.

    Measured: Baseline and post-intervention (4-6 weeks)

  3. 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.

    Measured: Baseline and post-intervention (4-6 weeks)

  4. 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.

    Measured: Throughout the intervention period (4-6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2025
  2. Study start26 Dec 2025 (estimated)
  3. Primary completion29 May 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07255521
Sponsor's protocol ID
hsalvador
Acronym
PREHAB-HSCT
Status last verified
Dec 2025
First submitted
20 Nov 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared because the study did not include a data-sharing plan in the protocol, and ethical approval and consent documents restrict data use to the research team only.

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal Prehabilitation in people with Hematopoietic Stem Cell Transplantation (HSCT), run by Hospital del Salvador at 2 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ivana Gonzales Valdivia, PT (+56942732848, igonzalezv@hsalvador.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Capacity (time frame: Baseline and post-intervention (4-6 weeks)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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