The Effect of Joint Range of Motion and Benson Relaxation Exercises on Dialysis Adequacy, Treatment Adherence, and Quality of Life in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- SEVEN-POINT SUBJECTIVE GLOBAL ASSESSMENT (SGD-7P)
研究概览
简要总结
The aim of this study is to determine the effects of range of motion and Benson relaxation exercises applied to patients undergoing hemodialysis treatment on dialysis adequacy, treatment adherence, and quality of life.
详细描述
The aim of this randomized controlled trial is to determine the effects of range of motion and Benson relaxation exercises on dialysis adequacy, treatment adherence, and quality of life in patients undergoing hemodialysis. The patients in the study will be divided into three groups. One group will perform range of motion exercises, another group will perform Benson relaxation exercises, and the third group will receive no intervention and will be assigned as the control group. The study will be conducted three times a week for eight weeks. A pre-test will be administered before the start of the study. Further tests will be conducted at the end of weeks 4 and 8. The final test results will be collected at the end of week 10.
Research hypotheses:
H1: Range of motion exercises performed on hemodialysis patients during dialysis affect their dialysis parameters.
H2: Range of motion exercises performed on hemodialysis patients during dialysis affect their dialysis adequacy.
H3: Range of motion exercises performed on hemodialysis patients during dialysis affect their quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
To determine randomization in sample selection, numbers from 1 to 72 were distributed into 3 groups using a simple random randomization method without repetition via https://www.random.org/. 72 patients were divided into three groups: Range of Motion Intervention, Benson Relaxation Exercise Intervention, and Control Group. Cards containing assignment information for intervention and control conditions were placed in pre-prepared, light-proof envelopes, and each envelope was numbered consecutively from 1 to 72. Each participant meeting the inclusion criteria was asked to randomly select one of these envelopes. The number inside the envelope chosen by the participant would be assigned to the relevant research group according to the pre-determined assignment list.
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
- •Being 18 years of age or older
- •Receiving HD treatment for at least 1 year
- •Receiving HD treatment 3 days a week for 4 hours
- •Being able to speak Turkish
- •Volunteering to participate in the study
排除标准
- •Patients with chronic diseases affecting breathing (advanced COPD, cancer)
- •Patients with hearing or speech problems
- •Patients with a diagnosed psychiatric condition
- •Patients with conditions that impede movement, such as burns, open wounds, edema, thrombophlebitis, limited mobility, fistulas, or previous surgical operations in the extremities
- •Exclusion Criteria from the Study:
- •Patients whose HD center changed during the study
- •Patients who did not wish to continue with the study
- •Patients who received a diagnosis of neurological or psychiatric illness during the study.
研究组 & 干预措施
Range of Motion Intervention (ROMI)
The study will be followed for 8 weeks for each patient. Since patients receive hemodialysis treatment 3 times a week, each patient will receive 24 sessions. The most frequent time interval for acute complications during hemodialysis is generally the first 1-2 hours of dialysis. Therefore, patients in the intervention group will start Range of Motion Exercises in the second hour of dialysis.
干预措施: Range of Motion Intervention (ROMI) (Other)
Benson Relaxation Exercise Intervention (BREI)
The study will be implemented and each patient will be monitored for 8 weeks. Since patients receive hemodialysis treatment 3 times a week, each patient will receive 24 sessions. The most frequent time interval for acute complications during hemodialysis is generally the first 1-2 hours of dialysis. Therefore, Benson Relaxation Exercises will be started in the second hour of dialysis for patients included in the intervention group.
干预措施: Benson Relaxation Exercise Intervention (BREI) (Other)
Control Group (CG)
The control group will not receive any intervention. Patients will continue their routine hemodialysis treatments.
结局指标
主要结局
SEVEN-POINT SUBJECTIVE GLOBAL ASSESSMENT (SGD-7P)
时间窗: From enrollment to the end of treatment at 8 weeks
It can be used to determine dialysis adequacy. The SGD-7P scale will be used to assess the nutritional status of patients. The SGD-7P was developed by Detsky et al. in 1984. The Turkish validity and reliability study was conducted by Eminsoy et al. in 2019. The scale has five evaluation criteria for medical history and three evaluation criteria for physical characteristics. For each evaluation criterion, an option is selected on a scale of 1-7 points. As a result of the average of the obtained scores, it is classified as 6-7 points (well-nourished), 3-5 points (mild-moderate malnutrition), and 1-2 points (severe malnutrition).
END-STAGE RENAL FAILURE - COMPLIANCE SCALE
时间窗: From enrollment to the end of treatment at 8 weeks
The scale was developed by Kim and Evangelista (2010). The Turkish adaptation, validity, and reliability of the scale were carried out by Ok and Kutlu (2017). The SDBYUÖ consists of 4 subscales: hemodialysis participation, medication adherence, fluid adherence, and diet adherence. Hemodialysis participation is the sum of the scores of items 1, 3, and 5; medication adherence is the score of item 6; fluid adherence is the score of item 8; and diet adherence is the score of item 9. The total score of the scale ranges from 0 to 1200. A higher score indicates higher treatment adherence.
Kidney Disease Patients Quality of Life Scale (KDQOL-36)
时间窗: From enrollment to the end of treatment at 8 weeks
The Turkish validity and reliability study of the scale, developed by Hayy et al. in 1994, was conducted by Yıldırım et al. in 2007. The scale consists of two scales: the SF-12 form, comprising a summary of the physical component and a summary of the mental component. It comprises a total of 4 sections and 36 items covering the burden of kidney disease, symptoms of kidney disease, and effects of kidney disease. There is no total score; each dimension is scored between 0 and 100. A score closer to 100 indicates a high quality of life, while a score closer to 0 indicates a low quality of life.
次要结局
未报告次要终点
研究者
Volkan Kina
LECTURER
Ardahan University