Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06379009

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • none

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at admission for kidney transplantation

Treatment

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

Follow-up

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

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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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