Evaluating The Feasibility And Safety Of A Group Exercise Program Supported By Audiovisual Media During Hemodialysis (GrExID)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Feasibility and Safety Assessment
研究概览
简要总结
People with chronic kidney disease (CKD) undergoing hemodialysis (HD) experience muscular complications, such as sarcopenia, which worsen their functional capacity and increase mortality. Exercise programs during HD are an effective strategy to combat sedentary behavior, and implementing them through innovative technologies could facilitate their adoption in clinics, benefiting more patients. Therefore, the study's objectives are to assess the feasibility and safety of a group exercise program supported by audiovisual media conducted during HD sessions. Additionally, it will analyze factors influencing adherence, identify potential causes for interruptions or failure to perform the prescribed exercise, and evaluate the risk and prevalence of sarcopenia, its association with low muscle strength, poor muscle quality, and physical inactivity.
详细描述
A 4-week randomized experimental study will be conducted, using an exercise protocol during HD, broadcast simultaneously on television. The frequency of exercise completion, reasons for non-completion, adverse events, as well as sarcopenia, muscle strength, muscle characteristics through ultrasound and electrical bioimpedance, and physical activity levels will be evaluated.
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)
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
- •Over 18 years old of both sexes;
- •Undergoing HD for at least three months in three sessions per week, four hours, totaling 12 hours per week.
排除标准
- •Lower limb amputations;
- •Neurological, musculoskeletal, or osteoarticular disorders;
- •Severe and unstable comorbidities;
- •Undergoing high doses of corticosteroids (>30 mg/day);
- •Inability to understand the measurement methods used.
研究组 & 干预措施
Intervention Group (IG)
Patients over 18 years old of both sexes, who have been undergoing HD for at least three months, generally in three sessions per week that are in the room that was randomized to do exercise.
干预措施: Exercise program supported by audiovisual media (Other)
Control Group (CG)
Patients over 18 years old of both sexes, who have been undergoing HD for at least three months, generally in three sessions per week that are in the room that was randomized to will continue with the usual treatment.
结局指标
主要结局
Feasibility and Safety Assessment
时间窗: From start to finish of intervention (4 weeks)
Feasibility will be assessed through adherence rate (number of sessiones performed out of sessions offered).
次要结局
- Sarcopenia Risk Assessment(It will be applied before and after the 4 weeks of intervention.)
- Muscle Strength Assessment(It will be applied before and after the 4 weeks of intervention.)
- Muscle Characteristics(It will be applied before and after the 4 weeks of intervention.)
- Physical Activity Level Assessment(It will be applied before and after the 4 weeks of intervention.)
- Muscle Strength Assessment(It will be applied before and after the 4 weeks of intervention)
- Muscle Characteristics(It will be applied before and after the 4 weeks of intervention)
研究者
Eva Segura Ortí
Principal Investigator
Cardenal Herrera University