Dialysis Exercise With a Bed Compatible Leg TRAiningstool

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases; Hemodialysis
• Interventions: Behavioral: Intradialytic exercise training; Behavioral: Control

• Registration Number: NCT06045442
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

This study is a randomised controlled intervention trial for dialysis patients with chronic kidney disease (n=32). The aim of this study is to test the effectiveness of an intradialytic training with a simple bed compatible trainingstool in comparison to a control group.

Detailed Description

Patients are randomised to either the intervention or control group at the beginning of the study. Both groups are evaluated at the beginning and after 2 months regarding their body composition, physical performance, fatigue and quality of life. The control group receives usual care. The intervention group receives an intradialytic exercise training with a bed compatible trainingstool.

Study Timeline

• Study Start: 2023-05-03
• Primary Completion: 2023-08-08
• Study Completion: 2023-08-08
• Status Verified: 2023-09
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-20
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients ≥ 18 years
• Patients who started dialysis more than 3 months ago
• Patients must be mentally and physically able to participate in exercise

Exclusion Criteria

• Patients who are not mentally or physically able to participate in intradialytic exercise. These include patients with uncontrolled high blood pressure and uncontrolled diabetes mellitus, diseases that impair physical performance or/and could be aggravated by activity, such as ischaemic cardiopathy or symptoms associated with coronary heart disease, chronic coronary heart disease, chronic lung disease and orthopaedic conditions that make exercise impossible.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intradialytic exercise training	3 months intradialytic exercise intervention: 30 minutes of endurance training at the dialysis unit with a dialysis training device, twice a week.
Control	Control	Usual Care

Primary Outcome Measures

Name	Time	Method
Timed-up-and-go test (TUG)	3 month	measured in time (seconds)
Sit-to-stand test (STS60)	3 month	measured in number of repetitions in 60 seconds

Secondary Outcome Measures

Name	Time	Method
Fatigue by Fatigue Assessment Scale (FAS)	3 month	measured in change of scale by questionnaire (scores can range from 10 (lowest level of fatigue) to 50 (highest level of fatigue)
muscle mass	3 month	measured in kg by bio-impedance analysis
Quality of life by Kidney Disease Quality of Life Instrument (KDQOL)	3 month	measured in change of scale by questionnaire (higher Score = better health; Questions are combined to form items and the average is calculated; Range from 0-100)
body fat mass	3 month	measured in kg by bio-impedance analysis
activity by Freiburg Questionnaire of physical activity	3 month	measured in change of scale by questionnaire (The higher the score, the more active the participant. the lowest level would be a score of 0)

Trial Locations

Locations (1)

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Bavaria, Germany