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Completed

NCT Number: NCT06045442

Dialysis Exercise With a Bed Compatible Leg TRAiningstool

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intradialytic exercise training

Behavioral

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).

Control

Behavioral

Usual care

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Acronym: DEXTRA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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