Liver TransplantationNCT01216722
Study of Resistance Strengthening Versus Ambulation Post-Liver Transplant
A study testing Resistance Strengthening Exercise Program in people with Liver Transplantation and Resistance Training, run by University of Miami at 1 site in United States.
Trial summary
Resistance strengthening exercise will increase strength and functional activity greater than ambulation in subjects post-liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Transplantation, Resistance Training, Activities of Daily Living
- What is being tested?
- Resistance Strengthening Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergone Liver Transplantation a minimum of 6 weeks and a maximum of 12 weeks prior to enrollment
- Ambulatory without physical assistance, but permitted to use a cane or walker
Who cannot join
- Diagnosis of Hepatocellular Carcinoma
- Significant Cardiopulmonary disease
- Neurological / Neuromuscular Disorder including cerebral vascular accident (CVA), Parkinson's Disease, Alzheimer's Disease, Dementia unrelated to Hepatic Encephalopathy, dystonia, multiple sclerosis, and polio.
- Blindness
- Inability to comprehend the English or Spanish Language
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Department of Physical Therapy
Coral Gables, Florida, 44146
About this study
Official title: Comparison of Targeted Lower Extremity Strengthening and Usual Care Progressive Ambulation in Subjects Post Liver Transplant: A Randomized Controlled Trial
Resistance strengthening exercise will increase strength and functional activity greater than ambulation in subjects post-liver transplantation.
Read the detailed description
Individuals post liver transplantation are significantly muscle wasted due to chronic liver disease. Current Usual care only involves progressive ambulation. Resistance exercise targeted at the lower extremities are anticipated to increase muscle strength in the muscles that extend the hip, extend the knee, and plantar flex the ankle more than seen with the usual care ambulation. The anticipated increases in strength should improve functional performance of activities such as standing from a chair, walking, and climbing stairs. The improvement in strength and functional performance should improve an individuals quality of life.
- Being tested
- Resistance Strengthening Exercise Program
- Keywords
- Muscle Wasting, Strengthening, Liver Disease, Transplant
- Medical subject headings
- Muscular Atrophy, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Strengthening Exercise ProgramOther
Home exercise Program. 3-4 days a week. 30 minutes a session. 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Resistance Strengthening | Experimental | Body weight antigravity positioning and elastic resistance bands are used to provide resistance for strengthening in supine, sitting, and standing in subjects post liver transplant. Receives: Other: Resistance Strengthening Exercise Program |
| Usual Care Control | No intervention | Subjects perform the usual care of progressive ambulation and increased activity post liver transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minute Walk Test
Measured: Baseline
Heel Rise Test
Measured: Baseline
30-Second Chair-Stand Test
Measured: Baseline
Bridge Test
Measured: Baseline
Six Minute Walk Test
Measured: 12 weeks
Heel Rise Test
Measured: 12 weeks
30-Second Chair-Stand Test
Measured: 12 weeks
Bridge Test
Measured: 12 weeks
Secondary outcomes (4)
Short Form (SF-36) Questionnaire
Measured: Baseline
Short Form (SF-36) Questionnaire
Measured: 12 weeks
Chronic Liver Disease Questionnaire (CLDQ)
Measured: Baseline
Chronic Liver Disease Questionnaire (CLDQ)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Investigators
- Kathryn Roach, PhD, PT, Study chair, University of MiamiDavid W Mandel, PhD, PT, Principal investigator, University of Miami Dept. of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216722
- Sponsor's protocol ID
- 20070787
- Status last verified
- Jul 2010
- First submitted
- 6 Oct 2010
- Last updated
- 7 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Targeted Lower Extremity Strengthening and Usual Care Progressive Ambulation in Subjects Post Liver Transplant: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01216722
- Acronym / sponsor ID
- 20070787
- Keywords
- Muscle Wasting, Strengthening, Liver Disease, Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Oct 2010 (estimated)
- 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.
Resistance strengthening exercise will increase strength and functional activity greater than ambulation in subjects post-liver transplantation.
Detailed description
Individuals post liver transplantation are significantly muscle wasted due to chronic liver disease. Current Usual care only involves progressive ambulation. Resistance exercise targeted at the lower extremities are anticipated to increase muscle strength in the muscles that extend the hip, extend the knee, and plantar flex the ankle more than seen with the usual care ambulation. The anticipated increases in strength should improve functional performance of activities such as standing from a chair, walking, and climbing stairs. The improvement in strength and functional performance should improve an individuals quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Strengthening | Experimental | Other: Resistance Strengthening Exercise ProgramBody weight antigravity positioning and elastic resistance bands are used to provide resistance for strengthening in supine, sitting, and standing in subjects post liver transplant. |
| Usual Care Control | No intervention | –Subjects perform the usual care of progressive ambulation and increased activity post liver transplant |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergone Liver Transplantation a minimum of 6 weeks and a maximum of 12 weeks prior to enrollment
- Ambulatory without physical assistance, but permitted to use a cane or walker
Key exclusion criteria (5 listed)
- Diagnosis of Hepatocellular Carcinoma
- Significant Cardiopulmonary disease
- Neurological / Neuromuscular Disorder including cerebral vascular accident (CVA), Parkinson's Disease, Alzheimer's Disease, Dementia unrelated to Hepatic Encephalopathy, dystonia, multiple sclerosis, and polio.
- Blindness
- Inability to comprehend the English or Spanish Language
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 |
|---|---|---|
| Resistance Strengthening Exercise ProgramHome exercise Program. 3-4 days a week. 30 minutes a session. 12 weeks | Other | Resistance Strengthening |
Primary outcome
Six Minute Walk Test
Time frame: Baseline
Heel Rise Test
Time frame: Baseline
30-Second Chair-Stand Test
Time frame: Baseline
Bridge Test
Time frame: Baseline
Six Minute Walk Test
Time frame: 12 weeks
Heel Rise Test
Time frame: 12 weeks
30-Second Chair-Stand Test
Time frame: 12 weeks
Bridge Test
Time frame: 12 weeks
4 secondary outcomes
Short Form (SF-36) Questionnaire
Time frame: Baseline
Short Form (SF-36) Questionnaire
Time frame: 12 weeks
Chronic Liver Disease Questionnaire (CLDQ)
Time frame: Baseline
Chronic Liver Disease Questionnaire (CLDQ)
Time frame: 12 weeks
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 Oct 2010.
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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.
Kathryn Roach, PhD, PT study chair
University of Miami
David W Mandel, PhD, PT principal investigator
University of Miami Dept. of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Strengthening Exercise Program in people with Liver Transplantation and Resistance Training, run by University of Miami 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 2 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 7 Oct 2010. 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 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?
Six Minute Walk Test (time frame: Baseline). The study lists 8 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 7 Oct 2010.