Effectiveness of a Group Intradialytic Exercise Program Supported by Audiovisual Media Combined With Mindfulness (GREXID MIND)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment rate Assessment
研究概览
简要总结
Chronic kidney disease in hemodialysis leads to musculoskeletal and psychological complications that affect functionality and quality of life. Intradialytic exercise and innovative technologies help reduce sedentary behaviour and improve health. Additionally, mindfulness decreases stress, anxiety, depression, and pain, promoting well-being and treatment adherence. There is a growing awareness of the need for more patient-centered approaches to address the substantial burden of physical and psychological symptoms that are not adequately managed by standard treatment strategies. Intradialytic exercise programs have become an effective strategy to counteract sedentary behavior and improve the overall health of patients. Implementing these programs through innovative technologies can facilitate their adoption and accessibility. Complementarily, mindfulness-based interventions help reduce stress, anxiety, and depression, improve mood, decrease pain perception, and promote relaxation and rest, which positively impact health-related quality of life and treatment adherence.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥3 months on HD (3 weekly sessions of 4 hours)
排除标准
- •lower-limb amputation;
- •neurological, musculoskeletal or osteoarticular disorders;
- •severe/unstable comorbidities (e.g., decompensated heart failure or diabetes, unstable angina, recent MI, uncontrolled hypertension, severe lung disease, acute infection);
- •<3 months on HD;
- •<2 sessions/week, or inability to understand assessments.
结局指标
主要结局
Recruitment rate Assessment
时间窗: Start of the study
Number of participants recruited/number of potential participants identified x 100
Retention rate
时间窗: From start to the end of the intervention (4 weeks)
Number of participants completing the intervention/number of participants recruited x 100
Adherence rate
时间窗: From start to the end of the intervention (4 weeks)
number of sessions completed/number of planned sessions x 100
Safety assessment by hypotension episodes
时间窗: From the start to the end of the intervention (4 weeks)
Exercise safety will be evaluated based on the total number of intradialysis group exercise sessions and their relationship with incidents or interruptions recorded in the progress sheets due to hypotension episodes.
Safety assessment by fatigue
时间窗: From start to the end of the intervention (4 weeks)
Exercise safety will be evaluated based on the total number of intradialysis group exercise sessions and their relationship with incidents or interruptions recorded in the progress sheets due to symptoms of fatigue.
Safety assessment by muscle cramps
时间窗: From the start to the end of the intervention (4 weeks)
Exercise safety will be evaluated based on the total number of intradialysis group exercise sessions and their relationship with incidents or interruptions recorded in the progress sheets due to muscle cramps.
次要结局
- Muscle strength assessment Handgrip(It will be tested before and after the 4 weeks of intervention)
- Lower limb muscle strength(From start to the end of the intervention (4 weeks))
- Anxiety and Depression(From start to the end of the intervention (4 weeks))
- Human Activity Profile(From start to the end of the intervention (4 weeks))
- Perceived Stress(From start to the end of the intervention (4 weeks))
- Perceptions from professionals and participants(From start to the end of the intervention (4 weeks))
- Screening for sarcopenia risk(From start to the end of the intervention (4 weeks))
研究者
Eva Segura Ortí
Professor
Cardenal Herrera University