Clinical Research Directory
Browse clinical research sites, groups, and studies.
Telerehabilitation in Hemodialysis Patients.
Sponsor: Hartcentrum Hasselt
Summary
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.
Official title: The Impact of Telerehabilitation in Physical Activity and Health Outcomes in Hemodialysis Patients.
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2024-06-04
Completion Date
2025-09-01
Last Updated
2025-03-24
Healthy Volunteers
No
Conditions
Interventions
Telerehabilitation
Intervention: Each enrolled participant within the telerehabilitation + usual care rehabilitation part will be provided a Fitbit® Charge 5 tracker, connected with the smartphone application Fitbit on the participant\'s smartphone by creating a Fitbit user account, and the tracker will be configured for each participant. A smartphone will be provided if the participant does not have a smartphone. Participants will be asked to continue wearing their tracker on their non-access arm at all times, other than bathing, for the 3-months study duration. Each week during this telerehabilitation phase, the physiotherapist (PT) will follow-up the participants' step counts during hemodialysis. Participants will receive feedback on their activity level and will be motivated by the PT, along with specific step goals for the upcoming week. The PT gives advise on how to incorporate more walking into participants' daily routine with specific attention for shared decision making during this feedback
Locations (1)
Hartcentrum Hasselt
Hasselt, Hasselt, Belgium