Impact of Prehabilitation Program on Outcomes of Hematopoietic Stem Cell Transplantation

NCT07833683 | Completed

• 1 other identifier: 25.04.634
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess whether a prehabilitation program can improve physical, nutritional, and psychological outcomes in participants undergoing hematopoietic stem cell transplantation (HSCT). Participants receiving HSCT were divided into two groups. The study group received the prehabilitation program in addition to routine care, while the control group received routine care. The outcomes of the two groups were compared to assess differences in physical capacity, fatigue, nutritional status, psychological status, and ability to perform daily activities. The study hypothesized that the prehabilitation program would have a positive effect on the outcomes of participants undergoing HSCT compared with the control group. Participants in the study group received a prehabilitation program that included physical exercise, nutritional support, and psychological support before and during the transplantation period.

Conditions

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (4)

• Perceived Exertion

  Perceived exertion was assessed using the Borg Rating of Perceived Exertion (RPE) Scale (6-20) before and after the prehabilitation program, with ratings categorized as very easy, easy, hard, or very hard. The Borg Scale was also used during each exercise session to guide exercise intensity and ensure safety; however, the outcome reported here reflects assessments conducted at baseline and post-intervention only. Unit of Measure: Number of participants (by category: very easy / easy / hard / very hard)

  Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)

• Lower Limb Muscle Strength

  Lower limb muscle strength and endurance were assessed using the 30-Second Chair Stand Test before and after the prehabilitation program. Results were compared to age-adjusted norms and categorized as below average, average, or above average. Unit of Measure: Number of participants (by category: below average / average / above average)

  Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)

• Upper Limb Muscle Strength (Hand Grip Strength)

  Upper limb (hand grip) muscle strength was assessed using a digital hand dynamometer before and after the prehabilitation program. Values were interpreted according to age- and gender-based normative data and categorized as weak, normal, or strong. Unit of Measure: Number of participants (by category: weak / normal / strong)

  Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)

• Fatigue Severity

  Fatigue was assessed using the Arabic version of the Fatigue Severity Scale (FSS-Ar) before and after the prehabilitation program. The scale ranges from 1 to 7, with higher scores indicating greater fatigue severity. Patients scored each item from 1 to 7, based on the extent, to which they agree or disagree with each statement (1 = strong disagreement, 7 = strong agreement). The FSS scored by calculating a mean score across all 9 items, each score then was rated as no fatigue, mild fatigue, moderate fatigue and severe fatigue. Unit of Measure: Number of participants (by category: fatigue / mild fatigue / moderate fatigue / severe fatigue)

  Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)

Secondary Outcomes (5)

• Nutritional Status (Malnutrition Risk)

  Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)

• Depression Severity

  Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)

• Anxiety Severity

  Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)

• Stress Severity

  Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)

• Physical functioning (activities of daily living)

  Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)

Study Arms (2)

prehabilitation program.

EXPERIMENTAL

Participants in this arm received the prehabilitation program in addition to routine care. The prehabilitation program included physical exercise, nutritional support, and psychological support before and during the hematopoietic stem cell transplantation period. The exercise component was based on the FITT principle and was adjusted according to the participant's clinical condition and any complications.

Behavioral: Prehabilitation Program

routine care

NO INTERVENTION

Participants in this arm received routine care provided as part of the usual hematopoietic stem cell transplantation care without the prehabilitation program.

Interventions

Prehabilitation Program BEHAVIORAL

Physical exercise Nutritional support Psychological support

prehabilitation program.

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, conscious patients from both gender with different educational levels.
• Patients scheduled for transplantation two weeks or more before.

You may not qualify if:

• Patients with neurological, musculoskeletal or psychological complications that preclude participation in the exercise program.
• Age more than 70 years old.

Sponsors & Collaborators

• Sara AbdelKader: lead

Study Sites (1)

Ain Shams University hospital, stem cell translantation unit

Cairo, Egypt

Location

Study Officials

• sara abdelkader abdelfattah, master degree

  faculty of nursing - Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: pre-test, post-test \& study control group

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)