Dialysis Exercise With a Bed Compatible Leg TRAiningstool

Chronic Kidney Diseases Clinical Trial

— DEXTRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06045442
• Other study ID #: 23-40-B
• Status: Completed
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: August 8, 2023

Study information

• Verified date: September 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hemodialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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).
• Control
Usual care

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sit-to-stand test (STS60)	measured in number of repetitions in 60 seconds	3 month
Primary	Timed-up-and-go test (TUG)	measured in time (seconds)	3 month
Secondary	muscle mass	measured in kg by bio-impedance analysis	3 month
Secondary	body fat mass	measured in kg by bio-impedance analysis	3 month
Secondary	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)	3 month
Secondary	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)	3 month
Secondary	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)	3 month