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Dialysis Exercise With a Bed Compatible Leg TRAiningstool (DEXTRA)

Primary Purpose

Chronic Kidney Diseases, Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intradialytic exercise training
Control
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Dialysis, Intradialytic exercise, Hemodialysis training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitätsklinikum Erlangen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

3 months intradialytic exercise intervention: 30 minutes of endurance training at the dialysis unit with a dialysis training device, twice a week.

Usual Care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

muscle mass
measured in kg by bio-impedance analysis
body fat mass
measured in kg by bio-impedance analysis
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)
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)
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)

Full Information

First Posted
September 13, 2023
Last Updated
September 20, 2023
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT06045442
Brief Title
Dialysis Exercise With a Bed Compatible Leg TRAiningstool
Acronym
DEXTRA
Official Title
Exercise During Hemodialysis With a Bed Compatible Trainingstool: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
August 8, 2023 (Actual)
Study Completion Date
August 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Hemodialysis
Keywords
Dialysis, Intradialytic exercise, Hemodialysis training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Random assignment in 1:1 ratio to either the intervention group (intradialytic exercise; twice a week for 30 min per dialysis session) or control group (Usual care)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
3 months intradialytic exercise intervention: 30 minutes of endurance training at the dialysis unit with a dialysis training device, twice a week.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Intradialytic exercise training
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Sit-to-stand test (STS60)
Description
measured in number of repetitions in 60 seconds
Time Frame
3 month
Title
Timed-up-and-go test (TUG)
Description
measured in time (seconds)
Time Frame
3 month
Secondary Outcome Measure Information:
Title
muscle mass
Description
measured in kg by bio-impedance analysis
Time Frame
3 month
Title
body fat mass
Description
measured in kg by bio-impedance analysis
Time Frame
3 month
Title
Quality of life by Kidney Disease Quality of Life Instrument (KDQOL)
Description
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)
Time Frame
3 month
Title
Fatigue by Fatigue Assessment Scale (FAS)
Description
measured in change of scale by questionnaire (scores can range from 10 (lowest level of fatigue) to 50 (highest level of fatigue)
Time Frame
3 month
Title
activity by Freiburg Questionnaire of physical activity
Description
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)
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Schiffer, Prof.
Organizational Affiliation
Universitätsklinikum Erlangen
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

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Dialysis Exercise With a Bed Compatible Leg TRAiningstool

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