Outcomes of Prehabilitation Program for Patients Undergoing Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Perceived Exertion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, conscious patients from both gender with different educational levels.
- •Patients scheduled for transplantation two weeks or more before.
排除标准
- •Patients with neurological, musculoskeletal or psychological complications that preclude participation in the exercise program.
- •Age more than 70 years old.
研究组 & 干预措施
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.
干预措施: Prehabilitation Program (Behavioral)
routine care
Participants in this arm received routine care provided as part of the usual hematopoietic stem cell transplantation care without the prehabilitation program.
结局指标
主要结局
Perceived Exertion
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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)
次要结局
- 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))
研究者
Sara AbdelKader
Assistant lecturer
Ain Shams University