THE EFFECTS OF INTRADİALYTİC AEROBİC EXERCİSE ON CLİNİCAL PARAMETERS, COPİNG WİTH ILLNESS, PERCEİVED BENEFİTS OF EXERCİSE AND BARRİERS TO EXERCİSE İN HAEMODİALYSİS PATİENTS: A RANDOMİSED CONTROLLED TRİAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Dialysis Patient-Perceived Exercise Benefits and Barriers Scale (DPEBBS)
研究概览
简要总结
This randomized controlled trial aims to investigate the effects of an 8-week intradialytic aerobic exercise program on clinical parameters, disease adaptation, and perceived exercise benefits and barriers in patients undergoing maintenance hemodialysis. Eligible participants will be randomly assigned to either an intervention group receiving supervised aerobic exercise during hemodialysis sessions or a control group receiving routine hemodialysis care. Aerobic exercise will be performed three times per week during hemodialysis for eight weeks. Exercise intensity will be individually adjusted according to the participant's subjective fatigue level using the 20-point Borg Rating of Perceived Exertion (RPE) scale, targeting an intensity of 11-13 ("light to somewhat hard"). Outcomes will be assessed before and after the intervention using validated clinical measurements and patient-reported outcome measures.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having received hemodialysis treatment for 4 hours a day, 3 days a week, for at least 3 months.
排除标准
- •Having a history of myocardial infarction within the last 3 months
- •Having angina pectoris or uncontrolled arrhythmia and uncontrolled hypertension
- •Having communication or cognitive problems to the extent that one cannot complete the required tests
- •Being pregnant or undergoing infertility treatment
- •Having a psychiatric diagnosis
研究组 & 干预措施
aerobic exercise
干预措施: Exercise (Other)
control group
结局指标
主要结局
Dialysis Patient-Perceived Exercise Benefits and Barriers Scale (DPEBBS)
时间窗: Two months
This is a 4-point Likert scale (1- Strongly Disagree, 4- Strongly Agree). The scale consists of 24 items and two open-ended questions. It comprises five sub-dimensions: "Daily Life (7 items)", "Exercise-related Undesirable Outcomes (7 items)", "Quality of Life (4 items)", "Exercise Effects (3 items)", and "Exercise Benefits (3 items)". The daily life and exercise-related undesirable outcomes sub-dimensions represent the obstacles to exercise, while the quality of life, exercise effects, and exercise benefits sub-dimensions represent the benefits of exercise. Items 3, 4, 6, 7, 10, 13, 16, 20, 22, and 23 comprise the benefits sub-dimension; items 1, 2, 5, 8, 9, 11, 12, 14, 15, 17-19, 21, and 24 comprise the obstacles sub-dimension. The items in the DPEBBS scale that represent barrier factors are reverse-coded. The scale is evaluated based on a total score (min=24, max=96). Higher scores indicate a greater perception of exercise benefits and fewer exercise barriers.
The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ)
时间窗: Two months
The scale, designed to assess adherence to end-stage renal failure, consists of nine questions and four sub-dimensions encompassing adherence behaviors: "hemodialysis participation," "medication adherence," "fluid restriction adherence," and "diet adherence." The total score obtainable from the scale ranges from 0 to 1200. Higher scores indicate higher adherence to treatment.
次要结局
未报告次要终点