Liver DiseasesNCT04924595
Exercise Intervention in Liver Transplant Candidates
A study testing Personalised exercise in people with Liver Diseases, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
Trial summary
The aim of the study is to investigate the effect of personalised exercise interventions in liver transplant candidates, aiming to prevent or limit sarcopenia and frailty, as well as improving their cardiorespiratory health. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Personalised exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesGreece
- Study dates
- 25 Apr 2021to 31 Dec 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver transplant candidates, accepted in the waiting list of the Surgical Department of Transplantation A.U.Th., General Hospital of Thessaloniki "Ippokratio".
Who cannot join
- Recent (<12 months) Acute Myocardial Infraction
- Recent (<12 months) brain strokes
- Uncontrolled and/or untreated arrythmia
- Hepatic encephalopathy
- Bed-bound patient
- Liver Transplantation
- Death
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Laboratory of Sports Medicine
Thermi, Thessaloniki, 57001
Surgical Department of Transplantation A.U.Th.
Thessaloniki, Thessaloniki, 54642
About this study
Official title: The Effect of a Personalised Training Programme on the Functional Ability and the Quality of Life of Candidates for Liver Transplantation
The aim of the study is to investigate the effect of personalised exercise interventions in liver transplant candidates, aiming to prevent or limit sarcopenia and frailty, as well as improving their cardiorespiratory health.
- Conditions
- Liver Diseases
- Being tested
- Personalised exercise
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised exerciseBehavioural
Personalised exercise intervention including aerobic and resistance training
| Study group | Role | What they receive |
|---|---|---|
| Regular treatment | No intervention | Not described |
| Exercise Intervention | Experimental | Not described Receives: Behavioral: Personalised exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline "Liver Frailty Index" value at 12 weeks
A frailty index for patients with cirrhosis, comprised of three performance-based metrics
Measured: After 12-week exercise intervention
Change from Baseline "6 Minute Walking Test" value at 12 weeks
A walking test for patients to evaluate their functional capacity
Measured: After 12-week exercise intervention
Secondary outcomes (1)
VO2max
Maximum oxygen consumption during incremental exercise
Measured: Before intervention initiation and after 12-week exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start25 Apr 2021
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilias Marios Oikonomou, Aristotle University Of Thessaloniki
- Investigators
- Ilias M Oikonomou, MD, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924595
- Sponsor's protocol ID
- AUTh65/2021
- Status last verified
- Jun 2021
- First submitted
- 30 May 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Personalised Training Programme on the Functional Ability and the Quality of Life of Candidates for Liver Transplantation
- ClinicalTrials.gov ID
- NCT04924595
- Acronym / sponsor ID
- AUTh65/2021
- Conditions
- Liver Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 14 Jun 2021 (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 aim of the study is to investigate the effect of personalised exercise interventions in liver transplant candidates, aiming to prevent or limit sarcopenia and frailty, as well as improving their cardiorespiratory health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular treatment | No intervention | – |
| Exercise Intervention | Experimental | Behavioral: Personalised exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Liver transplant candidates, accepted in the waiting list of the Surgical Department of Transplantation A.U.Th., General Hospital of Thessaloniki "Ippokratio".
Key exclusion criteria (7 listed)
- Recent (<12 months) Acute Myocardial Infraction
- Recent (<12 months) brain strokes
- Uncontrolled and/or untreated arrythmia
- Hepatic encephalopathy
- Bed-bound patient
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 |
|---|---|---|
| Personalised exercisePersonalised exercise intervention including aerobic and resistance training | Behavioural | Exercise Intervention |
Primary outcome
Change from Baseline "Liver Frailty Index" value at 12 weeks
Time frame: After 12-week exercise intervention
A frailty index for patients with cirrhosis, comprised of three performance-based metrics
Change from Baseline "6 Minute Walking Test" value at 12 weeks
Time frame: After 12-week exercise intervention
A walking test for patients to evaluate their functional capacity
1 secondary outcome
VO2max
Time frame: Before intervention initiation and after 12-week exercise intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ilias M Oikonomou, MD principal investigator
Aristotle University Of Thessaloniki
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalised exercise in people with Liver Diseases, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
Results are not available in the source record.
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?
Change from Baseline "Liver Frailty Index" value at 12 weeks (time frame: After 12-week exercise intervention). 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 14 Jun 2021.