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CompletedNCT07833683Updated Sep 22, 2026

Impact of Prehabilitation Program on Outcomes of Hematopoietic Stem Cell Transplantation

An interventional study of Prehabilitation Program in Hematopoietic Stem Cell Transplantation, sponsored by Sara AbdelKader. Completed at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Sara AbdelKader · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Non-randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

This study was conducted to assess the impact of a prehabilitation program on the physical, nutritional, and psychological outcomes of participants undergoing hematopoietic stem cell transplantation (HSCT).

Participants undergoing HSCT were divided into a study group and a control group. The study group received the prehabilitation program in addition to routine care, whereas the control group received routine care. The prehabilitation program was developed to address the physical, nutritional, and psychological needs of participants before and during the transplantation process.

The physical component of the program included an individualized exercise plan based on the FITT principle. Exercise was performed three days per week at mild to moderate intensity, with intensity monitored using the Borg Rating of Perceived Exertion scale. Exercise sessions included appropriate exercises to improve physical capacity and muscle strength, with the program adjusted according to the participant's condition and any complications during hospitalization.

The nutritional component included education and support before transplantation and during hospitalization. Participants received guidance regarding nutritional preparation, anticipated dietary restrictions, management of nutrition-related problems during treatment, and tips about food safety after discharge.

The psychological component included information and preparation regarding the HSCT process, support in coping with negative feelings, relaxation and breathing exercises, and strategies for identifying and replacing negative thoughts. Psychological support was provided to help participants cope with the physical and emotional challenges associated with transplantation.

Participants were assessed before and after the intervention using measures of fatigue, activities of daily living, nutritional status, psychological status, physical capacity, and muscle strength. The outcomes of the study and control groups were compared to determine whether the prehabilitation program was associated with improved outcomes following HSCT.

02

Conditions studied

  • Hematopoietic Stem Cell Transplantation
03

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with neurological, musculoskeletal or psychological complications that preclude participation in the exercise program.
  • Age more than 70 years old.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    prehabilitation program.

    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

  • No intervention
    routine care

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

Interventions

  • BehavioralPrehabilitation Program

    Physical exercise Nutritional support Psychological support

05

What researchers measure

Primary outcomes

  1. 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)

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

  2. 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)

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

  3. 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)

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

  4. 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)

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

Secondary outcomes

  1. Nutritional Status (Malnutrition Risk)

    Nutritional status was assessed using the Malnutrition Universal Screening Tool (MUST) before and after the prehabilitation program. MUST is a 5-step screening tool based on BMI, unplanned weight loss, and acute disease effect. Participants are categorized as low risk (score 0), medium risk (score 1), or high risk (score ≥ 2) of malnutrition. Unit of Measure: Number of participants (by risk category: low / medium / high)

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

  2. Depression Severity

    Depression was assessed using the depression subscale of the Arabic Depression Anxiety Stress Scale-8 items (DASS-8) before and after the prehabilitation program. The depression subscale contains 3 items, summed and categorized according to established cut-offs: normal (0-3), moderate (4-6), or severe (7-9). Unit of Measure: Number of participants (by category: normal / moderate / severe)

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

  3. Anxiety Severity

    Anxiety was assessed using the anxiety subscale of the Arabic Depression Anxiety Stress Scale-8 items (DASS-8) before and after the prehabilitation program. The anxiety subscale contains 3 items, summed and categorized according to established cut-offs: normal (0-3), moderate (4-6), or severe (7-9). Unit of Measure: Number of participants (by category: normal / moderate / severe)

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

  4. Stress Severity

    Stress was assessed using the stress subscale of the Arabic Depression Anxiety Stress Scale-8 items (DASS-8) before and after the prehabilitation program. The stress subscale contains 2 items, summed and categorized according to established cut-offs: normal (0-2), moderate (3-4), or severe (5-6). Unit of Measure: Number of participants (by category: normal / moderate / severe)

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

  5. Physical functioning (activities of daily living)

    Functional independence in daily activities was assessed using the Barthel Index, which evaluates the ability to perform activities such as walking, transferring, grooming, feeding, and toileting. Total scores were categorized as total dependency (0-20), severe dependency (21-60), moderate dependency (61-90), or slight dependency (91-99).Unit of Measure: Number of participants (by category: total dependency / severe dependency / moderate dependency / / slight dependency)

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

06

Study locations

1 site
  • Ain Shams University hospital, stem cell translantation unit
    Cairo, Egypt
07

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared with other researchers because the study data contain participant-level information and will be protected in accordance with ethical and privacy requirements.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07833683
Lead sponsor
Sara AbdelKader
Responsible party
Sara AbdelKader (Assistant lecturer, Ain Shams University) — Sponsor-investigator
First posted
Sep 22, 2026
Start date
Oct 1, 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026
Last update
Sep 22, 2026

Study contacts

sara abdelkader abdelfattah, master degree
principal investigator · faculty of nursing - Ain Shams University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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