Dialysis Exercise With a Bed Compatible Leg TRAiningstool

NCT06045442 | Completed

• 1 other identifier: 23-40-B
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Hemodialysis

Keywords

Dialysis; Intradialytic exercise; Hemodialysis training

Outcome Measures

Primary Outcomes (2)

• Sit-to-stand test (STS60)

  measured in number of repetitions in 60 seconds

  3 month

• Timed-up-and-go test (TUG)

  measured in time (seconds)

  3 month

Secondary Outcomes (5)

• muscle mass

  3 month

• body fat mass

  3 month

• Quality of life by Kidney Disease Quality of Life Instrument (KDQOL)

  3 month

• Fatigue by Fatigue Assessment Scale (FAS)

  3 month

• activity by Freiburg Questionnaire of physical activity

  3 month

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Usual Care

Behavioral: Control

Interventions

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).

Intervention

Control BEHAVIORAL

Usual care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years
• Patients who started dialysis more than 3 months ago
• Patients must be mentally and physically able to participate in exercise

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Mario Schiffer, Prof.

  Universitätsklinikum Erlangen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random assignment in 1:1 ratio to either the intervention group (intradialytic exercise; twice a week for 30 min per dialysis session) or control group (Usual care)

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: May 3, 2023
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

DE (1)