Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379009
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-15
Brief Title:
Effect of Home-based Training Program for Kidney Transplant Recipients HOMETRAIN-KTR
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None