Physical Activity After Organ TransplantationNCT03329586
High-intensity Training Safely Improves Exercise Capacity in Heart, Lung, Kidney, and Liver Transplant Recipients: a Comparative Study
A study testing High-intensity training in people with Physical Activity After Organ Transplantation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The investigators will investigate whether high-intensity exercise training can safely improve physical performance in long-term stable heart, kidney, lung, and liver transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity After Organ Transplantation
- What is being tested?
- High-intensity training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2013to 31 Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- minimum post-transplant period of 6 months
- no acute rejection during the immediately preceding 6 months
Who cannot join
- patients with cardiovascular or orthopedic contra-indications for intensive physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-intensity Training Safely Improves Exercise Capacity in Heart, Lung, Kidney, and Liver Transplant Recipients
The investigators will investigate whether high-intensity exercise training can safely improve physical performance in long-term stable heart, kidney, lung, and liver transplant recipients. Adult transplant recipients will participate in Transplantoux, a 6-month individualized home- and group-based training program, with the goal to cycle the Mont Ventoux in France. The investigators will do cardiopulmonary exercise testing : maximal oxygen consumption, maximal power and BMI.
- Being tested
- High-intensity training
- Keywords
- maximum oxygen consumption, organ transplantation, physical fitness, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity trainingOther
6-month individualized home- and group-based training program with the goal to cycle the Mont Ventoux in France
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Not described Receives: Other: High-intensity training |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max
Maximal oxygen consumption
Measured: 6 months after start training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Aug 2013
- Primary completion21 Jun 2014
- Study completion31 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Activity After Organ TransplantationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329586
- Sponsor's protocol ID
- Exercise in transplantation
- Status last verified
- Oct 2017
- First submitted
- 30 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Training Safely Improves Exercise Capacity in Heart, Lung, Kidney, and Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT03329586
- Acronym / sponsor ID
- Exercise in transplantation
- Keywords
- maximum oxygen consumption, organ transplantation, physical fitness, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 21 Jun 2014 (actual)
- Study completion
- 31 Jul 2014 (actual)
- First posted
- 6 Nov 2017 (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.
The investigators will investigate whether high-intensity exercise training can safely improve physical performance in long-term stable heart, kidney, lung, and liver transplant recipients. Adult transplant recipients will participate in Transplantoux, a 6-month individualized home- and group-based training program, with the goal to cycle the Mont Ventoux in France. The investigators will do cardiopulmonary exercise testing : maximal oxygen consumption, maximal power and BMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: High-intensity training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- minimum post-transplant period of 6 months
- no acute rejection during the immediately preceding 6 months
Key exclusion criteria (1 listed)
- patients with cardiovascular or orthopedic contra-indications for intensive physical exercise
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 |
|---|---|---|
| High-intensity training6-month individualized home- and group-based training program with the goal to cycle the Mont Ventoux in France | Other | Training |
Primary outcome
VO2max
Time frame: 6 months after start training
Maximal oxygen consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
Related trials for Physical Activity After Organ Transplantation
RecruitingObservational study
Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant
Organ Transplant
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity training in people with Physical Activity After Organ Transplantation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 7 Nov 2017. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max (time frame: 6 months after start training). 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 7 Nov 2017.