Prehabilitation for Patients Diagnosed With Blood Cancer and Treated With Alloge-neic Hematopoietic Stem Cell Transplantation - a National Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core questionnaires with 30 questions (EORTC QLQ C-30)
研究概览
简要总结
Seventy-five percent of patients treated with hematopoietic stem cell transplants survive one-year post-transplantation. However, this intensive treatment is associated with prolonged hospitalizations and significant deconditioning. Pathophysiological changes in skeletal muscle mass and function have notable implications for disease progression and long-term prognosis. Patients frequently report substantial rehabilitation needs, though these needs are highly individualized and fluctuate over time, with musculoskeletal dysfunction and fa-tigue being the most common barriers to prehabilitation. Furthermore, at least 35% of cancer patients are found to have inadequate daily protein intake, which may hinder improve-ments in physical performance through prehabilitation. Several recent studies have demonstrated the safety and feasibility of exercise-based prehabilitation interventions during the pre-transplant period. However, no full-scale randomized controlled trial (RCT) has been conducted to date.
详细描述
Evaluate the effectiveness of an individualized prehabilitation intervention in addition to usual care, compared to usual care alone on HRQoL, and secondary outcomes hospitalization, muscle mass and muscle function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes Assessor and statistician will be blinded
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients >18 years will be eligible for inclusion if they are scheduled for a allo-HSCT with at least four weeks before their scheduled transplantation date.
排除标准
- •pregnancy
- •physical or mental disabilities precluding test of muscle function
- •inability to read and understand Danish or English
研究组 & 干预措施
Usual care
The usual care group will receive standard care, including physio- and occupational therapy if admitted to the hospital, and potentially referral to rehabilitation in the municipality three months after transplantation.
干预措施: Usual care (Procedure)
Usual care plus the prehabilitation intervention
The prehabilitation group will in addition to usual care receive supervised individually tailored resistance training and optimized nutritional support
干预措施: Resistance training (Other)
Usual care plus the prehabilitation intervention
The prehabilitation group will in addition to usual care receive supervised individually tailored resistance training and optimized nutritional support
干预措施: Nutritional Support (Dietary Supplement)
Usual care plus the prehabilitation intervention
The prehabilitation group will in addition to usual care receive supervised individually tailored resistance training and optimized nutritional support
干预措施: Usual care (Procedure)
结局指标
主要结局
Health-Related Quality of Life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core questionnaires with 30 questions (EORTC QLQ C-30)
时间窗: From enrollment to 90 days post-transplantation
HRQoL measured using EORCT-C30v3.0. Scores are from 0 to 100 with lower scores meaning poorer quality of life and high scores meaning better overall quality of life.
次要结局
- Hospitalization(From enrollment to 90 days post-transplantation)
- Appendicular lean mass(From enrollment to 90 days post-transplantation)
- Appendicular Lean Mass Index(From enrollment to 90 days post-transplantation)
- Hand grip strength(From enrollment to 90 days post-transplantation.)
- Lower limb strength(From enrollment to 90 days post-transplantation.)
- Lower limb strength and endurance(From enrollment to 90 days post-transplantation.)
- Leg Extensor Power(From enrollment to 90 days post-transplantation)
研究者
Jan Christensen
Senior Researcher and Head of Research
Rigshospitalet, Denmark
