Hematopoietic Stem Cell TransplantationNCT07833683
Impact of Prehabilitation Program on Outcomes of Hematopoietic Stem Cell Transplantation
A study testing Prehabilitation Program in people with Hematopoietic Stem Cell Transplantation, run by Sara AbdelKader at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- Prehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, conscious patients from both gender with different educational levels.
- Patients scheduled for transplantation two weeks or more before.
Who cannot join
- Patients with neurological, musculoskeletal or psychological complications that preclude participation in the exercise program.
- Age more than 70 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Prehabilitation Program for Patients Undergoing Hematopoietic Stem Cell Transplantation
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.
Read more
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.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- Prehabilitation Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation ProgramBehavioural
Physical exercise Nutritional support Psychological support
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
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)
Measured: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
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)
Measured: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
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)
Measured: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
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)
Measured: 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)
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)
Measured: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- pre-test, post-test \& study control group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara AbdelKader
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara AbdelKader, Ain Shams University
- Investigators
- sara abdelkader abdelfattah, master degree, Principal investigator, faculty of nursing - Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833683
- Sponsor's protocol ID
- 25.04.634
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Prehabilitation Program for Patients Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07833683
- Acronym / sponsor ID
- 25.04.634
- Conditions
- Hematopoietic Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sara AbdelKaderUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pre-test, post-test \& study control group
| Arm | Type | Receives |
|---|---|---|
| prehabilitation program. | Experimental | Behavioral: Prehabilitation ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult, conscious patients from both gender with different educational levels.
- Patients scheduled for transplantation two weeks or more before.
Key exclusion criteria (2 listed)
- Patients with neurological, musculoskeletal or psychological complications that preclude participation in the exercise program.
- Age more than 70 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation ProgramPhysical exercise Nutritional support Psychological support | Behavioural | prehabilitation program. |
Primary outcome
Perceived Exertion
Time frame: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
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)
Lower Limb Muscle Strength
Time frame: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
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)
Upper Limb Muscle Strength (Hand Grip Strength)
Time frame: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
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)
Fatigue Severity
Time frame: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
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)
5 secondary outcomes
Nutritional Status (Malnutrition Risk)
Time frame: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
Depression Severity
Time frame: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
Anxiety Severity
Time frame: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
Stress Severity
Time frame: 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)
Time frame: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sara abdelkader abdelfattah, master degree principal investigator
faculty of nursing - Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation Program in people with Hematopoietic Stem Cell Transplantation, run by Sara AbdelKader at 1 site in Egypt.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Exertion (time frame: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)). The study lists 4 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 22 Sep 2026.