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CompletedNCT06045442DEXTRAUpdated Sep 22, 2023

Dialysis Exercise With a Bed Compatible Leg TRAiningstool

An interventional study of Intradialytic exercise training and Control in Chronic Kidney Diseases and Hemodialysis, sponsored by University of Erlangen-Nürnberg Medical School. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2023, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Kidney Diseases
  • Hemodialysis

Keywords

  • Dialysis
  • Intradialytic exercise
  • Hemodialysis training
03

In context

Renal Insufficiency, Chronic

3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.

This study's enrollment of 32 is below the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 275 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • 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

  • Active comparator
    Control

    Usual Care

    Behavioral: Control

Interventions

  • BehavioralIntradialytic 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).

  • BehavioralControl

    Usual care

06

What researchers measure

Primary outcomes

  1. Sit-to-stand test (STS60)

    measured in number of repetitions in 60 seconds

    Time frame: 3 month

  2. Timed-up-and-go test (TUG)

    measured in time (seconds)

    Time frame: 3 month

Secondary outcomes

  1. muscle mass

    measured in kg by bio-impedance analysis

    Time frame: 3 month

  2. body fat mass

    measured in kg by bio-impedance analysis

    Time frame: 3 month

  3. 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)

    Time frame: 3 month

  4. 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)

    Time frame: 3 month

  5. 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)

    Time frame: 3 month

07

Study locations

1 site
  • Universitätsklinikum Erlangen
    Erlangen, Bavaria 91054, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06045442
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
May 3, 2023
Primary completion
Aug 8, 2023
Completion
Aug 8, 2023
Last update
Sep 22, 2023

Study contacts

Mario Schiffer, Prof.
study director · Universitätsklinikum Erlangen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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