Telerehabilitation in Hemodialysis Patients.

NCT06891482 | Enrolling By Invitation

• 1 other identifier: 2023/162
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiology; Nefrology

Keywords

telerehabilitation; hemodialysis

Outcome Measures

Primary Outcomes (1)

• Change in daily step count

  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.

  From enrollment to 6 months post-randomization.

Secondary Outcomes (17)

• 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.

Study Arms (2)

Group B: 3 months control + 3 months intervention

ACTIVE COMPARATOR

Usual care rehabilitation: Each enrolled participant within the usual care rehabilitation will also 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 pedometer/tracker on their non-access arm at all times, other than bathing, one week at the beginning of the study and one week at the end of the study. In this group, there is no follow-up of the step counts with weekly structured feedback interventions. Participants will only receive rehabilitation during the hemodialysis one time per week by the PT

Behavioral: Telerehabilitation

Group A: 3 months intervention, 3 months control

ACTIVE COMPARATOR

3 months intervention (telerehabilitation) and 3 months control (usual care rehabilitation)

Behavioral: Telerehabilitation

Interventions

Telerehabilitation BEHAVIORAL

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

Group A: 3 months intervention, 3 months control; Group B: 3 months control + 3 months intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartcentrum Hasselt: lead

Study Sites (1)

Hartcentrum Hasselt

Hasselt, Hasselt, 9040, Belgium

Location

Related Publications (5)

• Hayhurst WS, Ahmed A. Assessment of physical activity in patients with chronic kidney disease and renal replacement therapy. Springerplus. 2015 Sep 21;4(1):536. doi: 10.1186/s40064-015-1338-3. eCollection 2015.

  PMID: 26413442 BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Malhotra R, Kumar U, Virgen P, Magallon B, Garimella PS, Chopra T, Kotanko P, Ikizler TA, Trzebinska D, Cadmus-Bertram L, Ix JH. Physical activity in hemodialysis patients on nondialysis and dialysis days: Prospective observational study. Hemodial Int. 2021 Apr;25(2):240-248. doi: 10.1111/hdi.12913. Epub 2021 Mar 1.

  PMID: 33650200 BACKGROUND

• Johansen KL, Chertow GM, Ng AV, Mulligan K, Carey S, Schoenfeld PY, Kent-Braun JA. Physical activity levels in patients on hemodialysis and healthy sedentary controls. Kidney Int. 2000 Jun;57(6):2564-70. doi: 10.1046/j.1523-1755.2000.00116.x.

  PMID: 10844626 BACKGROUND

• GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1151-1210. doi: 10.1016/S0140-6736(17)32152-9.

  PMID: 28919116 BACKGROUND

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Model Details: a randomized crossover trial

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: March 24, 2025
• Study Start: June 4, 2024
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 24, 2025

Record last verified: 2024-09

Locations

BE (1)