The Effect of Therapeutic Exercise in Patients Undergoing Autologous Stem Cell Transplantation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Handgrip Strength During the Transplantation Process
研究概览
简要总结
This interventional study assigns participants undergoing autologous hematopoietic stem cell transplantation to a supervised exercise program or usual care. The exercise program includes strength, endurance, and flexibility sessions for 8 weeks, 5 days per week. The control group receives usual care without a structured exercise program.
详细描述
This interventional study is conducted at Erciyes University Faculty of Medicine, Department of Hematology in patients scheduled for autologous hematopoietic stem cell transplantation. Eligible participants are assigned to either a supervised exercise program or usual care.
The exercise intervention consists of strength, endurance, and flexibility sessions performed five days per week for eight weeks under supervision. Participants in the control group receive standard medical care without a structured exercise program.
The study aims to examine the effects of the exercise program during the transplantation process in patients undergoing autologous stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors and data analysts were blinded to group allocation. Due to the nature of the exercise intervention, participants and exercise supervisors were not blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, <65 years
- •Able to exercise at time of enrolment.
- •no methastasis
排除标准
- •Unable to communicate or read in Turkish,
- •Contraindications to 3 T MRI (e.g., pacemaker or implanted metallic device).
- •co-morbid cardiac disease
- •painful joint
研究组 & 干预措施
Exercise Intervention In Autologous Stem Cell Transplant Patients:A Randomized Controlled Trial
The Exercise Group consisted of patients scheduled to undergo autologous bone marrow transplantation who were randomly assigned to the intervention arm of the study.
Initial number of participants: 12 Included in final analysis: 8
Intervention:
- 8-week structured exercise program
- Performed 5 days per week
- Included endurance, strength, and flexibility exercises Exercise intensity was determined using the 1-repetition maximum (1RM) principle for resistance training and the Karvonen method (40-60%) for aerobic training. Exercise intensity was monitored using the 24-point Borg Scale.
In addition to standard medical treatment, this group received a structured therapeutic exercise program.
干预措施: Exercise Program (Behavioral)
Exercise Intervention-Free Randomized Controlled Study in Autogenous Stem Cell Transplant Patients
The Control Group consisted of patients randomly assigned to the control arm of the study.
Initial number of participants: 12 Included in final analysis: 7
Intervention:
- Standard medical treatment only
- No structured exercise program was implemented This group served as the comparison group.
结局指标
主要结局
Change in Handgrip Strength During the Transplantation Process
时间窗: Baseline (4 weeks before transplantation),pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment 8(approximately 10-12 weeks total follow-up)
Change in handgrip strength measured using a hand dynamometer at four time points: 4 weeks before transplantation, 2 days before transplantation, during the engraftment period, and 2 weeks after engraftment in patients undergoing autologous bone marrow transplantation.
次要结局
- Change in Back Strength(Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).)
- Change in Leg Strength(Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).)
- Change in Waist Flexibility(Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).)
- Change in White Blood Cell Count(Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).)
- Change in Neutrophil Count(Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).)
- Change in Lymphocyte Count(Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).)
- Change in Platelet Count(Baseline (4 weeks before transplantation), pre-transplant (2 days before), during engraftment, and 2 weeks post-engraftment (approximately 10-12 weeks total follow-up).)
研究者
Mustafa Karakuş
Associate Professor
TC Erciyes University