Evaluating the Effect of a Structured Home-based Physical Training Program for Kidney Transplant Recipients With Impaired Pre-transplant Physical Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Clinical Frailty Scale
Study Overview
Brief Summary
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
Detailed Description
Title:
Evaluating the effect of a structured home-based physical training program for kidney transplant recipients with impaired pre-transplant physical function (HOMETRAIN KTR)
Background and Aims:
Frailty and impaired physical function are prevalent among patients undergoing kidney transplantation (KTx), and is an independent risk factor for poor outcome after transplantation. Limited number of studies have prospectively investigated the efficacy of exercise training for KTx-recipients with low pre-transplant physical function. Our aim is to evaluate the effect of a structured 12 week home-based physical training program delivered to recipients with low pre transplant physical function, on physical function and frailty at 1-year post transplant.
Method:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Both participants and investigators will know which arm the participants are randomized to. Training is not easy to mask
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Being mentally and cognitively capable of participating in the intervention and responding to follow-up questionnaires
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Clinical Frailty Scale
Time Frame: Baseline and after 52 weeks
Test for frailty. Validated test for this purpose. Score 1-9. The higher the score the more frail
6-minute walking distance test
Time Frame: Baseline and after 52 weeks
Test of physical function. How many meters the patient manage to walk in 6 minutes.
Secondary Outcomes
- 30 seconds Sit-to-stand test(Baseline, week 7, week 26 and week 52)
- Bone density test(Week 7 and week 52)
- Hand-grip strength(Baseline, week 7, week 26 and week 52)
- Bioelectrical impedance phase angle to measure muscle mass and strength.(Week 7 and 52)
Investigators
Tommy Aronsen
Nephrologist/phd-student
Oslo University Hospital