Dialysis Exercise With a Bed Compatible Leg TRAiningstool (DEXTRA)

Exercise During Hemodialysis With a Bed Compatible Trainingstool: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Hemodialysis
• Intervention / Treatment: Behavioral: Control; Behavioral: Intradialytic exercise training

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Universitatsklinikum Erlangen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Usual Care	Behavioral: Control; Usual care
Experimental: Intervention; 3 months intradialytic exercise intervention: 30 minutes of endurance training at the dialysis unit with a dialysis training device, twice a week.	Behavioral: Intradialytic exercise training; The patients in the intervention group will receive 3 months of endurance training, 2x/week for 30 min. 5 min of this should be a warm-up, 20 min of exertion and 5 min of cool down. The warm-up and cool-down should be equivalent to a very light load (Borg scale 9), whereas the exertion phase should be exhausting for the patients (Borg scale 14-15).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle mass	measured in kg by bio-impedance analysis	3 month
body fat mass	measured in kg by bio-impedance analysis	3 month
Quality of life by Kidney Disease Quality of Life Instrument (KDQOL)	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)	3 month
Fatigue by Fatigue Assessment Scale (FAS)	measured in change of scale by questionnaire (scores can range from 10 (lowest level of fatigue) to 50 (highest level of fatigue)	3 month
activity by Freiburg Questionnaire of physical activity	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)	3 month

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Study Director: Mario Schiffer, Prof., Universitatsklinikum Erlangen

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Actual): August 8, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Dialysis; Intradialytic exercise; Hemodialysis training
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 23-40-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No