Effect of Home-based Training Program for Kidney Transplant Recipients (HOMETRAIN-KTR)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
Does home-based training work in kidney transplant recipients with reduced physical function?
The goal of this clinical trial is to learn if home-based training works to better physical function in adult kidney transplant recipients. It will also learn about participants preoperative physical function. The main question it aim to answer is
* Does home-based training improves physical function in kidney transplant recipients. * All the participants are assessed to have reduced physical function before the transplantation
Participants will:
* follow either a home-based training program or todays standard of physical activity after kidney transplantation * the program starts 4 weeks after the transplantation and lasts for 12 weeks. A physiotherapist will help the participants in the beginning. * the program consists of both cardio-training, strength-straining and optional activity * the training group will be followed up every week by phone. Their activity will be documented via patients logs and heart rate monitor. * the effect of the training will be evaluated one year after the transplantation
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being 18 years old or older and going through Ktx
Scores 75 or lower at physical function at SF-36 at time of KTx
Able to perform the 6MWT
Able to speak, read and understand Norwegian or English
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Training
Other intervention12 week home-based training program
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Home-based trainingExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
6-minute walking distance test
Test of physical function. How many meters the patient manage to walk in 6 minutes.
Time frame
Baseline and after 52 weeks2
Clinical Frailty Scale
Test for frailty. Validated test for this purpose. Score 1-9. The higher the score the more frail
Time frame
Baseline and after 52 weeksSecondary outcomes
1
Hand-grip strength
Using a hand-dynamometer to measure hand-grip strength. Average of 3 trials
Time frame
Baseline, week 7, week 26 and week 522
30 seconds Sit-to-stand test
Get up from chair. Number of repetitions in 30 seconds
Time frame
Baseline, week 7, week 26 and week 523
Bone density test
Dual-energy X-ray absorptiometry (DXA)
Time frame
Week 7 and week 524
Bioelectrical impedance phase angle to measure muscle mass and strength.
Measuring bioelectrical impedance phase angle with a machine called BWA 2,0 Body. Water Analyzer. Phase angle is an indicator of muscular death, and is inversely related to muscle mass and strength in frail subjects.
Time frame
Week 7 and 52Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
South-Eastern Norway Regional Health Authority
Collaborator
Source ClinicalTrials.gov