End Stage Liver DiseaseNCT03266575
Pulmonary Rehabilitation in End-Stage Liver Disease
A study testing Pulmonary Rehabilitation Exercise and Home Based Exercise in people with End Stage Liver Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The exercise that will be performed in this study will include either pulmonary rehabilitation or a formal home based video strengthening program Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Liver Disease
- What is being tested?
- Pulmonary Rehabilitation Exercise and Home Based Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 9 Dec 2024
- 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
- wait listed for liver transplantation with poor 6 MWT
Who cannot join
- age < 18 years
- recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month
- large esophageal varices without primary prophylaxis
- active excessive alcohol intake (in the previous 3 months)
- current overt uncontrolled hepatic encephalopathy
- hepatopulmonary syndrome with uncontrolled hypoxia
Show all 9Show fewer
- portopulmonary hypertension
- inability to perform exercise
- marked symptomatic comorbidities (cardiac, pulmonary, renal).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Does Pulmonary Rehabilitation Improve Frailty and Sarcopenia in End Stage Liver Disease?
The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The exercise that will be performed in this study will include either pulmonary rehabilitation or a formal home based video strengthening program
Read the detailed description
Participants will be randomized into two groups. The Pulmonary Rehabilitation group will undergo exercise under a supervised setting for a total duration of 12 weeks. Patients will perform endurance (treadmill or cycle ergometer), strength (weight resistance) and flexibility training twice a week for a period of an hour per session. Exercises will be supervised by physiotherapists or exercise physiologists. Compliance and performance will be monitored by the trainer. They will receive a pedometer for home use. The Home based program group will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the second week, in their home environment. The total duration of the intervention will be 12 weeks. Patients will be provided with pedometers, REST video and binder, with instructions on how to perform exercises, and resistance bands.
- Conditions
- End Stage Liver Disease
- Being tested
- Pulmonary Rehabilitation Exercise, Home Based Exercise
- Keywords
- Frailty, Sarcopenia, Pulmonary Rehabilitation
- Medical subject headings
- End Stage Liver Disease, Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Rehabilitation ExerciseBehavioural
Participants will undergo Pulmonary Rehabilitation exercise. Participants will perform endurance (treadmill or cycle ergometer), strength (weight resistance) and flexibility training twice a week for a period of an hour per session
Home Based ExerciseBehavioural
Participants will undergo Home based exercise program consisting of strength and conditioning. Participants will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the second week, in their home environment. The total duration of the intervention will be 12 weeks. Participants will be provided with pedometers, REST video and binder, with instructions on how to perform exercises, and resistance bands.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation | Active comparator | Participants will participate in formal Pulmonary Rehabilitation Exercise program Receives: Behavioral: Pulmonary Rehabilitation Exercise |
| Home based program | Active comparator | Participants will participate in a Home based Exercise program Receives: Behavioral: Home Based Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 minute walk test
Participants will walk on a straight, flat surface for 6 minutes at a self-determined pace.
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Feb 2018
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Why it stopped: difficulty recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DiseaseStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized to pulmonary rehab vs home based exercise rpogram
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kymberly D. Watt, Mayo Clinic
- Investigators
- Kymberly D Watt, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266575
- Sponsor's protocol ID
- 17-000852
- Status last verified
- Dec 2024
- First submitted
- 30 Mar 2017
- Last updated
- 12 Dec 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pulmonary Rehabilitation Improve Frailty and Sarcopenia in End Stage Liver Disease?
- ClinicalTrials.gov ID
- NCT03266575
- Acronym / sponsor ID
- 17-000852
- Conditions
- End Stage Liver Disease
- Keywords
- Frailty, Sarcopenia, Pulmonary Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 30 Aug 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 purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The exercise that will be performed in this study will include either pulmonary rehabilitation or a formal home based video strengthening program
Detailed description
Participants will be randomized into two groups. The Pulmonary Rehabilitation group will undergo exercise under a supervised setting for a total duration of 12 weeks. Patients will perform endurance (treadmill or cycle ergometer), strength (weight resistance) and flexibility training twice a week for a period of an hour per session. Exercises will be supervised by physiotherapists or exercise physiologists. Compliance and performance will be monitored by the trainer. They will receive a pedometer for home use. The Home based program group will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the second week, in their home environment. The total duration of the intervention will be 12 weeks. Patients will be provided with pedometers, REST video and binder, with instructions on how to perform exercises, and resistance bands.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized to pulmonary rehab vs home based exercise rpogram
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation | Active comparator | Behavioral: Pulmonary Rehabilitation ExerciseParticipants will participate in formal Pulmonary Rehabilitation Exercise program |
| Home based program | Active comparator | Behavioral: Home Based ExerciseParticipants will participate in a Home based Exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- wait listed for liver transplantation with poor 6 MWT
Key exclusion criteria (9 listed)
- age < 18 years
- recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month
- large esophageal varices without primary prophylaxis
- active excessive alcohol intake (in the previous 3 months)
- current overt uncontrolled hepatic encephalopathy
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 |
|---|---|---|
| Pulmonary Rehabilitation ExerciseParticipants will undergo Pulmonary Rehabilitation exercise. Participants will perform endurance (treadmill or cycle ergometer), strength (weight resistance) and flexibility training twice a week for a period of an hour per session | Behavioural | Pulmonary Rehabilitation |
| Home Based ExerciseParticipants will undergo Home based exercise program consisting of strength and conditioning. Participants will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the second week, in their home environment. The total duration of the intervention will be 12 weeks. Participants will be provided with pedometers, REST video and binder, with instructions on how to perform exercises, and resistance bands. | Behavioural | Home based program |
Primary outcome
Change in 6 minute walk test
Time frame: baseline, 3 months
Participants will walk on a straight, flat surface for 6 minutes at a self-determined pace.
Results and safety
The study was stopped early (reason given: difficulty recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Acute-on-Chronic Liver Failure (ACLF)
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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.
Kymberly D Watt 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 Pulmonary Rehabilitation Exercise and Home Based Exercise in people with End Stage Liver Disease, 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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Dec 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 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?
The study was stopped early (reason given: difficulty recruiting). 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 in 6 minute walk test (time frame: baseline, 3 months). 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 12 Dec 2024.