Ain Shams University hospital, stem cell translantation unit
Cairo, Egypt
NCT Number: NCT07833683
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.
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Notify Me20 year–70 year
All sexes
Interventional
Not applicable
Cairo, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Physical exercise Nutritional support Psychological support
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)
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)
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)
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)
Time frame: Baseline (≥2 weeks before HSCT) and post-intervention (up to 4 weeks after HSCT, assessed prior to hospital discharge)
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)
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)
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)
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)
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)
Sara AbdelKader
Other
Outcomes of Prehabilitation Program for Patients Undergoing Hematopoietic Stem Cell Transplantation
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