Effects of Intradialytic Resistance and Flexibility Exercises on Clinical Outcomes in Hemodialysis Patients: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in dialysis adequacy assessed by Kt/V (urea)
研究概览
简要总结
This study examined whether different types of exercise performed during hemodialysis sessions affect patients' health and quality of life. Patients receiving regular hemodialysis were assigned to resistance exercise, flexibility exercise, or usual care during dialysis. Changes in health-related outcomes were evaluated before and after the exercise period.
详细描述
This single-center pilot study was conducted to explore the effects of exercise performed during hemodialysis on patients' health. Adult patients undergoing maintenance hemodialysis participated in one of three groups: resistance exercise, flexibility exercise, or usual care without exercise. The exercise programs were carried out during routine dialysis sessions under supervision.
Patients' clinical measurements and self-reported health outcomes were assessed at the start of the study and again after completion of the exercise period. The study was carried out between December 2020 and April 2021 following approval by the institutional ethics committee.
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
- None
盲法说明
Due to the nature of the exercise interventions, masking was not feasible.
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
- •Adults aged 18 years or older
- •Receiving maintenance hemodialysis for at least 3 months
- •Stable clinical condition
- •Ability to participate in exercise during hemodialysis sessions
- •Provided written informed consent
排除标准
- •Acute illness or unstable cardiovascular disease
- •Severe musculoskeletal or neurological conditions limiting exercise
- •Recent hospitalization
- •Cognitive impairment preventing cooperation
- •Participation in another structured exercise program
研究组 & 干预措施
Resistance Exercise
Participants performed supervised resistance exercise during routine hemodialysis sessions. Exercises were conducted three times per week during the first two hours of dialysis over the study period.
干预措施: Resistance Exercise (Behavioral)
Flexibility Exercise
Participants performed supervised flexibility and stretching exercises during routine hemodialysis sessions. Exercises were conducted three times per week during the first two hours of dialysis over the study period.
干预措施: Flexibility Exercise (Behavioral)
Usual Care (Control)
Participants received usual hemodialysis care without any structured exercise program during dialysis sessions.
结局指标
主要结局
Change in dialysis adequacy assessed by Kt/V (urea)
时间窗: From baseline to 12 weeks
Change in dialysis adequacy measured by single-pool Kt/V (urea).
Change in dialysis adequacy assessed by urea reduction ratio (URR)
时间窗: From baseline to 12 weeks
Change in dialysis adequacy measured by urea reduction ratio (URR), expressed as a percentage
次要结局
- Change in Short Form-36 (SF-36) Health-Related Quality of Life score(From baseline to 12 weeks)
- Change in Beck Depression Inventory score(From baseline to 12 weeks)
- Change in body mass index (BMI)(From baseline to 12 weeks)
- Change in fat tissue index (FTI)(From baseline to 12 weeks)
- Change in lean tissue index (LTI)(From baseline to 12 weeks)
- Change in physical function assessed by the 6-minute walk test (6MWT)(From baseline to 12 weeks)
研究者
Dilek GİBYELİ GENEK
Principal Investigator
Muğla Sıtkı Koçman University