Kidney Transplant; ComplicationsNCT06379009
Effect of Home-based Training Program for Kidney Transplant Recipients (HOMETRAIN-KTR)
A study testing Training in people with Kidney Transplant; Complications and Frailty, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Frailty, Physical Disability
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 7 Feb 2024to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Effect of a Structured Home-based Physical Training Program for Kidney Transplant Recipients With Impaired Pre-transplant Physical Function
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
Read more
- 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
Read the 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.
- Being tested
- Training
- Keywords
- Training
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
12 week home-based training program
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walking distance test
Test of physical function. How many meters the patient manage to walk in 6 minutes.
Measured: 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
Measured: Baseline and after 52 weeks
Secondary outcomes (4)
Hand-grip strength
Using a hand-dynamometer to measure hand-grip strength. Average of 3 trials
Measured: Baseline, week 7, week 26 and week 52
30 seconds Sit-to-stand test
Get up from chair. Number of repetitions in 30 seconds
Measured: Baseline, week 7, week 26 and week 52
Bone density test
Dual-energy X-ray absorptiometry (DXA)
Measured: Week 7 and week 52
Bioelectrical impedance phase angle to measure muscle mass and strength.
Measuring bioelectrical impedance phase angle with a machine called BWA 2,0 Body. Water Analyzer. Phase angle is an indicator of muscular death, and is inversely related to muscle mass and strength in frail subjects.
Measured: Week 7 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start7 Feb 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Tommy Aronsen, Oslo University Hospital
- Investigators
- Marit Helen Andersen, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379009
- Sponsor's protocol ID
- 473076
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of a Structured Home-based Physical Training Program for Kidney Transplant Recipients With Impaired Pre-transplant Physical Function
- ClinicalTrials.gov ID
- NCT06379009
- Acronym / sponsor ID
- 473076
- Keywords
- Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Home-based training | Experimental | Other: TrainingStructured 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training12 week home-based training program | Other | Home-based training |
Primary outcome
6-minute walking distance test
Time frame: Baseline and after 52 weeks
Test of physical function. How many meters the patient manage to walk in 6 minutes.
Clinical Frailty Scale
Time frame: Baseline and after 52 weeks
Test for frailty. Validated test for this purpose. Score 1-9. The higher the score the more frail
4 secondary outcomes
Hand-grip strength
Time frame: Baseline, week 7, week 26 and week 52
30 seconds Sit-to-stand test
Time frame: Baseline, week 7, week 26 and week 52
Bone density test
Time frame: Week 7 and week 52
Bioelectrical impedance phase angle to measure muscle mass and strength.
Time frame: Week 7 and 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marit Helen Andersen principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Kidney Transplant; Complications and Frailty, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommy Aronsen, MD (004790923913, tomaro@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walking distance test (time frame: Baseline and after 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.