Dialysis Exercise With a Bed Compatible Leg TRAiningstool

University of Erlangen-Nürnberg Medical School32 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Diseases Hemodialysis

Interventions

Intradialytic exercise trainingBEHAVIORAL

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).

ControlBEHAVIORAL

Usual care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Outcomes

Primary Outcomes

Sit-to-stand test (STS60)

measured in number of repetitions in 60 seconds

Time frame: 3 month

Timed-up-and-go test (TUG)

measured in time (seconds)

Time frame: 3 month

Secondary Outcomes

muscle mass

measured in kg by bio-impedance analysis

Time frame: 3 month

body fat mass

measured in kg by bio-impedance analysis

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 3 month

Data from ClinicalTrials.gov

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