Dialysis Exercise With a Bed Compatible Leg TRAiningstool

NCT ID: NCT06045442

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-03
• Study Completion Date: 2023-08-08

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.

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.

Conditions

Chronic Kidney Diseases; Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

3 months intradialytic exercise intervention: 30 minutes of endurance training at the dialysis unit with a dialysis training device, twice a week.

Group Type: EXPERIMENTAL

Intradialytic exercise training

Intervention Type: 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

Usual Care

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Usual care

Interventions

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).

Intervention Type: BEHAVIORAL

Control

Usual care

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mario Schiffer, Prof.

Role: STUDY_DIRECTOR

Universitätsklinikum Erlangen

Locations

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Countries

Germany

Other Identifiers

23-40-B

Identifier Type: -

Identifier Source: org_study_id