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

NCT06379009 | Recruiting

• 1 other identifier: 473076
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Transplant; Complications; Frailty; Physical Disability

Keywords

Training

Outcome Measures

Primary Outcomes (2)

• 6-minute walking distance test

  Test of physical function. How many meters the patient manage to walk in 6 minutes.

  Baseline and after 52 weeks

• Clinical Frailty Scale

  Test for frailty. Validated test for this purpose. Score 1-9. The higher the score the more frail

  Baseline and after 52 weeks

Secondary Outcomes (4)

• Hand-grip strength

  Baseline, week 7, week 26 and week 52

• 30 seconds Sit-to-stand test

  Baseline, week 7, week 26 and week 52

• Bone density test

  Week 7 and week 52

• Bioelectrical impedance phase angle to measure muscle mass and strength.

  Week 7 and 52

Study Arms (2)

Home-based training

EXPERIMENTAL

Structured home-based training program over 12 week period (in addition to standard care). The program has been prepared by physiotherapists and starts 4 weeks after kidney transplantation. It consists of 2 sessions of strength training and 1 session of cardio training each week. In addition, optional training sessions on the other days of the week. The patients will be followed up by phone every week, heart rate monitor and patients logs. A physiotherapist will guide the patients in the beginning of the intervention period

Other: Training

Standard of care

NO INTERVENTION

This group will undergo standard physical training program in addition to standard care. They will be informed about the importance of regular exercise after discharge from hospital.

Interventions

Training OTHER

12 week home-based training program

Home-based training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- none

Sponsors & Collaborators

• Oslo University Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0372, Norway

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marit Helen Andersen

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommy Aronsen, MD

CONTACT

004790923913; tomaro@ous-hf.no

Krstian Heldal, MD, PHD

CONTACT

004790018417; hkr@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Both participants and investigators will know which arm the participants are randomized to. Training is not easy to mask
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist/phd-student

Model Details: 2 arms randomized control study. The intervention arm is exposed of a 12 week home-based training program. The control arm follow standard of care.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 23, 2024
• Study Start: February 7, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)