The Impact of Telerehabilitation in Physical Activity and Health Outcomes in Hemodialysis Patients.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in daily step count
研究概览
简要总结
Chronic kidney disease is the third most common cause of death, with a prevalence of 10-12%. Patients undergoing hemodialysis often exhibit low levels of physical activity, leading to various health issues, including poor quality of life, fatigue, psychiatric disorders, cardiovascular diseases, musculoskeletal symptoms, and increased mortality. Increased physical activity in this population has been associated with improvements in these health conditions. Walking, for instance, has been linked to a 33% reduction in mortality and a 21% decrease in the need for kidney transplantation. However, recent findings indicate that the average step count among hemodialysis patients is significantly lower compared to the healthy population.
Telerehabilitation, utilizing digital innovations such as smartphones and smartwatches, is considered a promising strategy to promote physical activity. This randomized crossover study aims to investigate whether telerehabilitation, combined with a structured feedback intervention via a wearable activity tracker, can increase physical activity in hemodialysis patients. The study seeks to address the limited knowledge on the effectiveness of digital interventions in this population. The hypothesis is that such an intervention could positively influence physical activity levels in this group.
The primary objectives of this study are to increase the average step count, improve dialysis parameters, enhance quality of life, improve digital health literacy, increase exercise capacity, reduce overall and cardiovascular mortality, and decrease unplanned hospitalizations in cardiology, nephrology, or geriatrics departments. The study will be conducted at the dialysis center of Jessa Hospital in Hasselt, Belgium, and will include 46 patients. Each participant will consecutively undergo two different types of interventions: telerehabilitation combined with usual care rehabilitation and usual care rehabilitation only. Following recruitment, participants will be randomly assigned to one of two pre-specified intervention sequences: telerehabilitation plus usual care rehabilitation followed by usual care rehabilitation only, or usual care rehabilitation followed by telerehabilitation plus usual care rehabilitation. The study duration will be six months, with each phase lasting three months. Outcome evaluations will be conducted at three time points: baseline assessment, assessment after the first intervention, and assessment after the second intervention.
The primary outcome is the daily step count, measured by a Fitbit® Charge 5 tracker. Secondary outcomes include physical function (measured by the Short Physical Performance Battery, Two-Minute Walking Test, Cardiopulmonary Exercise Testing, Hand Grip Strength, reduction of sedentary behavior, and body composition monitoring), blood parameters, dialysis parameters, and quality of life.
详细描述
Chronic kidney disease (CKD) is the third most common cause of death, with a prevalence of 10-12% among men and women. Prior studies indicate that individuals receiving hemodialysis (HD) perform less physical activity (PA) than healthy individuals due to the frequency and duration of hemodialysis sessions, which typically occur two to three times per week and last between three and four hours per session. Despite recommendations from the World Health Organization (WHO) that individuals undergoing HD should exercise for at least 30 minutes per day, most do not achieve these recommended levels.
Physical inactivity among individuals undergoing HD is associated with increased morbidity, including poor quality of life, fatigue, psychiatric disorders, cardiovascular events, musculoskeletal symptoms, and higher mortality. Research suggests that increasing physical activity can lead to improvements in physical function, stabilization of cognitive function, reduced risk of developing comorbid conditions, and enhanced quality of life. A recent meta-analysis reported that higher levels of physical activity result in a 14% reduction in all-cause mortality compared to lower activity levels among individuals with CKD. This finding highlights the importance of promoting physical activity to improve clinical outcomes in this population.
Walking is widely recommended as a fundamental and accessible form of physical activity for individuals with chronic diseases, including CKD. Walking has been associated with a reduction in overall mortality and a decreased need for renal replacement therapy. Recommendations suggest that individuals with CKD should aim for 7,000 to 10,000 steps per day, translating existing exercise guidelines into step counts. However, a recent systematic review found that the average daily step count among individuals with CKD is significantly lower than that of the healthy population.
The increasing availability of digital health technologies presents opportunities for improving rehabilitation strategies. Telerehabilitation, which integrates digital innovations such as smartphone applications, smartwatches, and teleconsultations, offers a promising approach to promoting physical activity. Wearable devices that continuously monitor personal health data, in combination with smartphone applications that allow users to access this information, provide valuable insights into risk factors and their management. Smaller trials have demonstrated the effectiveness of telerehabilitation, and systematic reviews confirm its clinical and cost-effectiveness.
Wearable activity trackers offer an accurate, user-friendly, and cost-effective means of monitoring physical activity. These devices provide objective step count data, enabling researchers to assess physical activity levels over extended periods, even outside the dialysis unit. Compared to self-reported methods such as diaries or questionnaires, wearable trackers are considered a reliable tool for measuring daily physical activity, making them particularly useful for research on individuals with CKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with end-stage renal disease receiving in-center hemodialysis at the frequency of two to three times a week, with each session lasting ≥ 3 h
- •Age ≥18 years
- •Having signed and dated an informed consent form, indicating that the subject (or a legally-recognized representative) has been informed of all pertinent aspects of the study
- •Possession of and/or able to use a smartphone
- •Possession of internet connectivity
- •Dutch speaking and understanding
- •Be clinically stable
- •Willing and physically able to follow a technology-supported physical activity intervention and other study procedures in a six months follow-up period
排除标准
- •Orthopedic, neurologic or any other pathologic condition which makes the participant physically unable to technology-supported physical activity intervention and other study procedures in a six months follow-up period
- •Cognitive disabilities or mental illnesses
- •Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the participant to participate in this study or a life expectancy of less than three months based on investigators judgement
- •Participants who were hospitalized at the time of recruitment
- •Current or recent participation in other technology-supported programs, even when not directly targeting exercise capacity
结局指标
主要结局
Change in daily step count
时间窗: From enrollment to 6 months post-randomization.
The primary outcome of this study is the daily step count, measured at 3 months and 6 months after randomization using an accelerometer (Fitbit® Charge 5 tracker). Participants will be asked to wear this accelerometer on their wrist continuously throughout the study period. The daily step count data will be transferred via Bluetooth technology to the Fitbit application interface. It is hypothesized that participants in the intervention group will experience a greater improvement in step counts compared to those in the control group.
次要结局
- Insulin Resistance (HOMA-IR Index)(From enrollment to 6 months post-randomization.)
- Minutes to Recovery after a Hemodialysis Session (minutes)(From enrollment to 6 months post-randomization.)
- Dialysis Adequacy (Kt/V ratio)(From enrollment to 6 months post-randomization.)
- Dialysis Symptoms Index (DSI)(From enrollment to 6 months post-randomization.)
- Digital health Literacy(From enrollment to 6 months post-randomization.)
- Quality of life assessment(From enrollment to 6 months post-randomization.)
- Short Physical Performance Battery (SPPB) Score (0-12 points)(From enrollment to 6 months post-randomization.)
- Two-Minute Walking Test (2MWT) (meters)(From enrollment to 6 months post-randomization.)
- Quadriceps Strength Test (Newtons, N)(From enrollment to 6 months post-randomization.)
- Hemoglobin (g/dL)(From enrollment to 6 months post-randomization.)
- Hematocrit (%)(From enrollment to 6 months post-randomization.)
- Red Blood Cell Count (×10⁶/μL)(From enrollment to 6 months post-randomization.)
- Serum Calcium (mg/dL)(From enrollment to 6 months post-randomization.)
- Potassium (mEq/L)(From enrollment to 6 months post-randomization.)
- Phosphate (mEq/L)(From enrollment to 6 months post-randomization.)
- Parathyroid Hormone (PTH) (pg/mL)(From enrollment to 6 months post-randomization.)
- Blood Urea Nitrogen (BUN) Pre- and Post-HD (mg/dL)(From enrollment to 6 months post-randomization.)
研究者
Kizilkilic Sevda
prof. dr.
Hartcentrum Hasselt