Effect of Home-based Training Program for Kidney Transplant Recipients (HOMETRAIN-KTR)

Frailty Clinical Trial

Official title: Evaluating the Effect of a Structured Home-based Physical Training Program for Kidney Transplant Recipients With Impaired Pre-transplant Physical Function

Status Recruiting

Clinical Trial 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

Clinical Trial 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:

HOMETRAIN-KTR is a 2-arm unblinded Norwegian clinical trial with RCT design. Patients will be recruited at admission for KTx at Oslo University Hospital, Rikshospitalet. Patients who score below 60 at 36-Item Short Form Survey will be included and tested with 6-minute walking test, Clinical Frailty Scale, hand-grip strength, 30 seconds Sit-to-Stand test, and questionnaire about physical activity and psychological distress. Included patients are randomized to either training group or control group (standard of care). The training group will, under supervision by a physiotherapist, start a 12-week structured home-based training program from week 4 post-KTx. The training program consist of a combination of strength training, cardio training and optional activities. During the intervention period, the intervention group will receive regular follow-up by phone. The training sessions will be documented via patients logs and heart rate monitor. At one year post-KTx, all patients will undergo the same tests as at inclusion.

Inclusion of patients will start in January 2024, and continue for the next 2-3 years. The investigators aim to include 200 patients, 100 in each arm. The study will evaluate physical function, frailty, graft function, patient survival, HRQoL and physiological distress during the time-span of the study.

Hypothesis:

The HOMETRAIN-KTR study is supposed to bring new knowledge about the effect of a physical training program on frail KTx-recipients. Such information is highly relevant to improve KTx outcomes and to optimize the utilization of the limited source of donor organs. ;

Related Conditions & MeSH terms

• Frailty
• Kidney Transplant; Complications
• Physical Disability

• NCT number: NCT06379009
• Study type: Interventional
• Source: Oslo University Hospital
• Contact: Tommy Aronsen, MD
• Phone: 004790923913
• Email: tomaro@ous-hf.no
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2024
• Completion date: January 1, 2028