Actively Recruiting
Evaluating the Effect of a Structured Home-based Physical Training Program for Kidney Transplant Recipients With Impaired Pre-transplant Physical Function
Led by Oslo University Hospital · Updated on 2024-04-24
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
S
South-Eastern Norway Regional Health Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a home-based training program can improve physical function in adult kidney transplant recipients who have reduced physical function before transplantation. This study is a randomized clinical trial designed to assess how a structured physical training program affects frailty and physical performance one year after kidney transplantation. It aims to provide new knowledge to improve outcomes for transplant recipients and optimize donor organ use. Participants are randomly assigned to two groups: one follows a 12-week home-based training program starting four weeks after transplantation, and the other receives standard care with advice on regular exercise. The training includes two strength sessions and one cardio session each week, with additional optional activities. A physiotherapist guides participants initially, and the training group receives weekly phone follow-ups. Activity is tracked using patient logs and heart rate monitors. Throughout the study, participants undergo assessments including the 6-minute walking test and Clinical Frailty Scale at baseline and one year post-transplant. Additional tests such as hand-grip strength, sit-to-stand test, bone density, and muscle mass measurements occur at various points up to one year. The study monitors physical function, frailty, graft function, survival, quality of life, and psychological distress over the study period, which is expected to enroll patients over 2-3 years starting in early 2024.
CONDITIONS
Brief Title
Effect of Home-based Training Program for Kidney Transplant Recipients (HOMETRAIN-KTR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Being 18 years old or older and going through kidney transplantation
- Scores 75 or lower on physical function at SF-36 at time of transplantation
- Able to perform the 6-minute walking test
- Able to speak, read, and understand Norwegian or English
- Mentally and cognitively capable of participating in the intervention and responding to follow-up questionnaires
You will not qualify if you...
- none
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at admission for kidney transplantation
Duration - 12 weeks starting 4 weeks post-transplant
Participants in the training group complete a 12-week structured home-based physical training program starting 4 weeks after kidney transplantation. This program includes strength training, cardio training, and optional activities with weekly phone follow-ups by a physiotherapist. The control group receives standard care with advice on regular exercise.
Weekly phone follow-ups for training group; training sessions documented by patients
Duration - Up to 1 year after transplantation
Participants undergo physical function and frailty assessments at 1 year post-transplant to evaluate the effects of the training program.
1 visit at 1 year post-transplant (in-person) for assessments
Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway, 0372
Actively Recruiting
Research Team
T
Tommy Aronsen, MD
K
Krstian Heldal, MD, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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