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Dialysis Exercise With a Bed Compatible Leg TRAiningstool (DEXTRA)

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ClinicalTrials.gov Identifier: NCT06045442
Recruitment Status : Completed
First Posted : September 21, 2023
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Hemodialysis Behavioral: Intradialytic exercise training Behavioral: Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Exercise During Hemodialysis With a Bed Compatible Trainingstool: a Randomized Controlled Trial
Actual Study Start Date : May 3, 2023
Actual Primary Completion Date : August 8, 2023
Actual Study Completion Date : August 8, 2023

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Arms and Interventions
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Arm Intervention/treatment
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).
Active Comparator: Control
Usual Care
 Behavioral: Control
Usual care


Outcome Measures
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Primary Outcome Measures :
  1. Sit-to-stand test (STS60) [ Time Frame: 3 month ]
    measured in number of repetitions in 60 seconds

  2. Timed-up-and-go test (TUG) [ Time Frame: 3 month ]
    measured in time (seconds)


Secondary Outcome Measures :
  1. muscle mass [ Time Frame: 3 month ]
    measured in kg by bio-impedance analysis

  2. body fat mass [ Time Frame: 3 month ]
    measured in kg by bio-impedance analysis

  3. Quality of life by Kidney Disease Quality of Life Instrument (KDQOL) [ Time Frame: 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)

  4. Fatigue by Fatigue Assessment Scale (FAS) [ Time Frame: 3 month ]
    measured in change of scale by questionnaire (scores can range from 10 (lowest level of fatigue) to 50 (highest level of fatigue)

  5. activity by Freiburg Questionnaire of physical activity [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045442


Locations
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Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Study Director: Mario Schiffer, Prof. Universitätsklinikum Erlangen
More Information
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT06045442    
Other Study ID Numbers: 23-40-B
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Dialysis
Intradialytic exercise
Hemodialysis training
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes