Liver TransplantNCT02058498
Increasing Activity in Liver Transplant Patients
A study testing Physical activity in people with Liver Transplant, run by Mayo Clinic at 1 site in United States.
Trial summary
Will adult liver transplant patients who are provided with physical activity (walking) instructions increase their physical activity and perceive an improved quality of life? Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients 18-65 years of age who receive a liver transplant at Mayo Clinic Jacksonville.
- Adult patients who are 5-21 days post liver transplant.
- Must be followed by Mayo Clinic Jacksonville at 4 months postoperatively.
- Approved by a hepatologist and/or transplant surgeon to participate.
Who cannot join
- Patients with active infections
- Patients with encephalopathy or cognitive dysfunction
- Patients who receive a combined liver-kidney transplant
- Patients with severe debility
- Patients who require assistance to ambulate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Physical Activity in Post Liver Transplant Patients
Will adult liver transplant patients who are provided with physical activity (walking) instructions increase their physical activity and perceive an improved quality of life?
- Conditions
- Liver Transplant
- Being tested
- Physical activity
- Keywords
- Liver transplant, Physical Activity, Quality of Life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplant Patients | Experimental | Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ)
The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. The following formula is used to calculate the MET: MET=8(vigorous activity) (minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes).
Measured: Baseline, 6 weeks
Secondary outcomes (2)
Quality of Life at Baseline, 6 Weeks, and 4 Months
Participants reported their perceived quality of life using a scale 1 - 10, with 1 being the worst and 10 being the best.
Measured: Baseline, 6 weeks, 4 months
Number of Patients Who Document Their Physical Activity
8 participants documented their physical activity at 6 weeks. 6 participants documented their physical activity at 4 months.
Measured: Baseline to 6 weeks, repeated measure at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer L. Serotta, A.R.N.P., Mayo Clinic
- Investigators
- Jennifer Serotta, ARNP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058498
- Sponsor's protocol ID
- 13-004699
- Status last verified
- Apr 2016
- First submitted
- 4 Feb 2014
- Last updated
- 6 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity in Post Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT02058498
- Acronym / sponsor ID
- 13-004699
- Conditions
- Liver Transplant
- Keywords
- Liver transplant, Physical Activity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Posted 6 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Will adult liver transplant patients who are provided with physical activity (walking) instructions increase their physical activity and perceive an improved quality of life?
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant Patients | Experimental | Behavioral: Physical activityParticipants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients 18-65 years of age who receive a liver transplant at Mayo Clinic Jacksonville.
- Adult patients who are 5-21 days post liver transplant.
- Must be followed by Mayo Clinic Jacksonville at 4 months postoperatively.
- Approved by a hepatologist and/or transplant surgeon to participate.
Key exclusion criteria (5 listed)
- Patients with active infections
- Patients with encephalopathy or cognitive dysfunction
- Patients who receive a combined liver-kidney transplant
- Patients with severe debility
- Patients who require assistance to ambulate.
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 |
|---|---|---|
| Physical activityParticipants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months. | Behavioural | Liver Transplant Patients |
Primary outcome
Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, 6 weeks
The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. The following formula is used to calculate the MET: MET=8(vigorous activity) (minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes).
2 secondary outcomes
Quality of Life at Baseline, 6 Weeks, and 4 Months
Time frame: Baseline, 6 weeks, 4 months
Number of Patients Who Document Their Physical Activity
Time frame: Baseline to 6 weeks, repeated measure at 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jennifer Serotta, ARNP principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Liver Transplant, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 5 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 6 Jun 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ) (time frame: Baseline, 6 weeks). 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 6 Jun 2016.