Evaluating the Clinical and Cost-effectiveness of Intra-dialytic Exercise for the Improvement of Health-related Quality of Life in People With Stage 5 Chronic Kidney Disease Undergoing Maintenance Haemodialysis Renal Replacement Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- Change from basline in quality of life on the Kidney Disease QOL questionnaire Physical Composite Score (KDQOL-PCS) at month 6.
研究概览
简要总结
The PEDAL study aims to evaluate the effectiveness of a 9-month intradialytic exercise training intervention designed to improve quality of life (QOL) and alleviate functional limitations in patients with stage 5 Chronic Kidney Disease (CKD) who are on haemodialysis. Exercise rehabilitation will be compared against established treatment options available within UK NHS haemodialysis (HD) units. A qualitative substudy will also investigate the experience and acceptability of the intervention for both participants and members of the renal care team. In addition, we want to examine whether this type of additional exercise treatment is cost effective within the health service setting.
PEDAL is designed as a multi centre randomised clinical trial (RCT) and will recruit 380 adult patients who have been on HD for at least 3 months, from 10 HD sites located in Scotland, England and Wales. The type of exercise programming will consist of cycling exercise performed during each dialysis session plus a muscle conditioning programme performed twice per week. All exercise sessions will be supervised by a physiotherapy assistant. The exercise prescription will be individualised for all patients on the basis of their fitness and clinical status.
The main objective is to examine the impact of exercise rehabilitation on quality of life and well being of patients. We hypothesise that the exercise training delivered during haemodialysis treatment will significantly improve the functional limitations/abilities of the patients leading to the detection of clinically beneficial improvement in quality of life outcome, as measured by the KDQOL-36 physical composite score (PCS) at the primary end point.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prevalent Stage 5 CKD patients (GFR <15 mL/min) receiving maintenance haemodialysis therapy for more than 3 months
- •Male or female
- •Aged >18 years
- •Able to provide written informed consent
排除标准
- •Patients unlikely to be on HD for > 6 months - (this includes cachectic patients, those with severe heart failure, patients in whom dialysis withdrawal is being considered, and patients likely to receive a live-donor transplant or transfer to PD in that period of time);
- •Less than 3 months after the initiation of haemodialysis (patients in this time-frame are generally less clinically stable, many having vascular access procedures performed, and rates of inter-current events, including death and hospitalisation, are very much higher in the first 3 months after commencement of chronic haemodialysis);
- •Deemed to be clinically unstable by treating physician;
- •Dementia or severe cognitive impairment (as will be unable to give consent and/or complete questionnaire assessments);
- •Severe psychiatric disorders - except treated stable
研究组 & 干预措施
INTRA-DIALYTIC EXERCISE TRAINING
Using a modified cycle ergometer, aerobic exercise will be performed in a semi-recumbent position, 3 times per week during the first two hours of haemodialysis. The initial prescription will be set in the moderate intensity range of 40-60% of peak aerobic capacity, progressing to 75% level by the end of the intervention.
Twice per week patients will also complete lower extremity muscular conditioning exercise, using ankle weights, after the aerobic cycling exercise.
干预措施: INTRA-DIALYTIC EXERCISE TRAINING (Behavioral)
HAEMODIALYSIS RENAL REPLACEMENT THERAPY
Haemodialysis is the most common dialysis (renal replacement) treatment for kidney failure.
They may also receive dietary advice, counselling, input from social workers, and other forms of educational support.
结局指标
主要结局
Change from basline in quality of life on the Kidney Disease QOL questionnaire Physical Composite Score (KDQOL-PCS) at month 6.
时间窗: Baseline, 6 months
The KDQOL is a disease-specific quality of life measure.
次要结局
未报告次要终点