Peripheral Vascular DiseaseNCT02767895
Prehabilitation for PAD Revascularization Patients
A study testing Prehabilitation in people with Peripheral Vascular Disease and Peripheral Artery Disease, run by University of Michigan at 1 site in United States.
Trial summary
Patients undergoing elective revascularization of their peripheral artery disease will be randomized to a prehabilitation program or usual care prior to their scheduled procedure. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Vascular Disease, Peripheral Artery Disease
- What is being tested?
- Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 7 Nov 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented lower extremity PAD
- Ability to walk at least 1 block
- Sedentary
- Medical clearance from the surgical team
- Competent to provide consent
Who cannot join
- Life expectancy < 6 months
- Co-morbidities which limit walking to a severe degree
- Signs of critical limb ischemia
- Recent or current enrollment in a formal exercise program
- Recent cardiovascular events including stroke, TIA, severe valve disease, etc.
- Current substance abuse
- Psychiatric disorder which limits ability to participate in study procedures
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Trial of Prehabilitation Among Patients Undergoing PAD Revascularization
Patients undergoing elective revascularization of their peripheral artery disease will be randomized to a prehabilitation program or usual care prior to their scheduled procedure.
Read the detailed description
Patients undergoing elective revascularization for their peripheral artery disease will be randomized to a "prehabilitation" program prior to their surgery or to usual care. The prehabilitation program is self-directed program designed to improve health and quality of life prior to surgery. The program is currently offered to general surgery patients; this study will examine the feasibility and acceptability of such a program in a different patient population.
- Being tested
- Prehabilitation
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
Also called MSHOP - Michigan Surgical & Health Optimization Program
Participants will receive an informational DVD, a pedometer, an incentive spirometer and access to the program website to help promote healthful behaviors and improved well-being in the days leading up to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Participants will be referred to the Michigan Surgical \& Health Optimization Program in the month leading up to their surgery. Individuals are encouraged to increase their physical activity, practice stress reduction, and other behaviors associated with good health Receives: Behavioral: Prehabilitation |
| Usual Care | No intervention | Participants will follow the pre-operative instructions provided by their surgical team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Study as Indicated by Number of Participants
The feasibility of the study will be assessed by analyzing the recruitment of subjects to the study and the compliance of recruited subjects to the protocol. Feasibility will be defined as able to screening, approaching, and enrolling 25 eligible patients to the pilot study.
Measured: 1 day
Acceptability of Study as Indicated by Percentage of Participation
The willingness of patients to enroll and complete the basic study procedures. Acceptability will be defined as low drop out-rates (<15%), completion of quality of life surveys, and >85% usage of the pedometers.
Measured: 8 months
Secondary outcomes (2)
Increased Physical Activity Characteristics
Increased physical activity characteristics will be assessed through the Godin Leisure Time and International Physical Activity Questionnaire, and questionnaires on barriers to and self-efficacy of exercise.
Measured: 8 months
Health-related Quality of Life
Health-related quality of life and physical activity characteristics will be measured during the pre, peri, and post-operative period. This will be done through PROMIS surveys, which assess physical function, fatigue, depression, anxiety, and ability to participate in and satisfaction with social roles/activities.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study start1 Jul 2016
- Primary completion7 Nov 2017
- Study completion7 Nov 2017
Why it stopped: Difficulty with enrollment and change in available study resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth A. Jackson, University of Michigan
- Investigators
- Elizabeth Jackson, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767895
- Sponsor's protocol ID
- HUM00113096
- Status last verified
- Sep 2019
- First submitted
- 6 May 2016
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Prehabilitation Among Patients Undergoing PAD Revascularization
- ClinicalTrials.gov ID
- NCT02767895
- Acronym / sponsor ID
- HUM00113096
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with enrollment and change in available study resources
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 10 May 2016 (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.
Patients undergoing elective revascularization of their peripheral artery disease will be randomized to a prehabilitation program or usual care prior to their scheduled procedure.
Detailed description
Patients undergoing elective revascularization for their peripheral artery disease will be randomized to a "prehabilitation" program prior to their surgery or to usual care. The prehabilitation program is self-directed program designed to improve health and quality of life prior to surgery. The program is currently offered to general surgery patients; this study will examine the feasibility and acceptability of such a program in a different patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: PrehabilitationParticipants will be referred to the Michigan Surgical \& Health Optimization Program in the month leading up to their surgery. Individuals are encouraged to increase their physical activity, practice stress reduction, and other behaviors associated with good health |
| Usual Care | No intervention | –Participants will follow the pre-operative instructions provided by their surgical team. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented lower extremity PAD
- Ability to walk at least 1 block
- Sedentary
- Medical clearance from the surgical team
- Competent to provide consent
Key exclusion criteria (8 listed)
- Life expectancy < 6 months
- Co-morbidities which limit walking to a severe degree
- Signs of critical limb ischemia
- Recent or current enrollment in a formal exercise program
- Recent cardiovascular events including stroke, TIA, severe valve disease, etc.
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 |
|---|---|---|
| PrehabilitationAlso: MSHOP - Michigan Surgical & Health Optimization ProgramParticipants will receive an informational DVD, a pedometer, an incentive spirometer and access to the program website to help promote healthful behaviors and improved well-being in the days leading up to surgery. | Behavioural | Prehabilitation |
Primary outcome
Feasibility of Study as Indicated by Number of Participants
Time frame: 1 day
The feasibility of the study will be assessed by analyzing the recruitment of subjects to the study and the compliance of recruited subjects to the protocol. Feasibility will be defined as able to screening, approaching, and enrolling 25 eligible patients to the pilot study.
Acceptability of Study as Indicated by Percentage of Participation
Time frame: 8 months
The willingness of patients to enroll and complete the basic study procedures. Acceptability will be defined as low drop out-rates (<15%), completion of quality of life surveys, and >85% usage of the pedometers.
2 secondary outcomes
Increased Physical Activity Characteristics
Time frame: 8 months
Health-related Quality of Life
Time frame: 8 months
Results and safety
The study was stopped early (reason given: Difficulty with enrollment and change in available study resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Elizabeth Jackson, MD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Peripheral Vascular Disease and Peripheral Artery Disease, run by University of Michigan 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 5 inclusion and 8 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 9 Sep 2019. 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 with enrollment and change in available study resources). 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?
Feasibility of Study as Indicated by Number of Participants (time frame: 1 day). 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 9 Sep 2019.