Peripheral Arterial DiseaseROMEPADNCT05209724
Remote Monitoring of Home Exercise in Peripheral Arterial Disease
A study testing Provider supervision/ feedback in people with Peripheral Arterial Disease, run by Dallas VA Medical Center at 1 site in United States.
Trial summary
Many patients with blockages in the arteries in their legs (peripheral arterial disease, "PAD") suffer from pain in their legs when walking. Exercise therapy is known to decrease pain levels as well as increase the distance that patients with PAD can walk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Provider supervision/ feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2021to Jun 2023
- 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
- Age >18
- Diagnosis of PAD (based on ABI <0.9 in either leg or prior intervention) with mild/moderate claudication
Who cannot join
- Prior above ankle amputation
- Wheelchair bound
- Inability to walk >200m during 6 min walk test
- Use of walking aid other than cane
- Walking impairment for reason other than PAD
- Critical limb ischemia
- Planned vascular surgery within next 3 months, recent surgery within past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dallas North Texas Veterans Affairs Hospital
Dallas, Texas, 75216
Cristina Sanchez, 214-857-3048, cristina.sanchez@va.gov
About this study
Many patients with blockages in the arteries in their legs (peripheral arterial disease, "PAD") suffer from pain in their legs when walking. Exercise therapy is known to decrease pain levels as well as increase the distance that patients with PAD can walk. The purpose of this study is to understand whether home exercise using a digital exercise monitoring system (LIVMOR) with provider supervision/ feedback will improve walking distance compared to those undergoing home exercise using the same monitoring system but without provider supervision/ feedback.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Provider supervision/ feedback
- Keywords
- PAD, Home walking, Remote monitoring, Claudication
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider supervision/ feedbackBehavioural
Provider supervision/ feedback provided before and after walking sessions
| Study group | Role | What they receive |
|---|---|---|
| Provider Supervised | Experimental | Digital monitoring system with provider supervision Receives: Behavioral: Provider supervision/ feedback |
| Self Supervised | No intervention | Digital monitoring system without provider supervision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 minute walk test distance between groups
Change in 6 minute walk test distance between groups
Measured: 12 weeks
Secondary outcomes (2)
Change in Walking Impairment Questionnaire score
Change in Walking Impairment Questionnaire score between groups
Measured: 12 weeks
Change in VascuQOL-6 (VQ6) quality of life survey
Change in VascuQOL-6 (VQ6) quality of life survey between groups
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 posted27 Jan 2022
- Study start21 Nov 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Subhash Banerjee, Dallas VA Medical Center
- Investigators
- Subhash Banerjee, MD, MBA, Principal investigator, Dallas VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209724
- Sponsor's protocol ID
- 1602740
- Acronym
- ROMEPAD
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD are to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring of Home Exercise in Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT05209724
- Acronym / sponsor ID
- ROMEPAD / 1602740
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD, Home walking, Remote monitoring, Claudication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Study start
- 21 Nov 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 27 Jan 2022 (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.
Many patients with blockages in the arteries in their legs (peripheral arterial disease, "PAD") suffer from pain in their legs when walking. Exercise therapy is known to decrease pain levels as well as increase the distance that patients with PAD can walk. The purpose of this study is to understand whether home exercise using a digital exercise monitoring system (LIVMOR) with provider supervision/ feedback will improve walking distance compared to those undergoing home exercise using the same monitoring system but without provider supervision/ feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider Supervised | Experimental | Behavioral: Provider supervision/ feedbackDigital monitoring system with provider supervision |
| Self Supervised | No intervention | –Digital monitoring system without provider supervision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18
- Diagnosis of PAD (based on ABI <0.9 in either leg or prior intervention) with mild/moderate claudication
Key exclusion criteria (7 listed)
- Prior above ankle amputation
- Wheelchair bound
- Inability to walk >200m during 6 min walk test
- Use of walking aid other than cane
- Walking impairment for reason other than PAD
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 |
|---|---|---|
| Provider supervision/ feedbackProvider supervision/ feedback provided before and after walking sessions | Behavioural | Provider Supervised |
Primary outcome
Change in 6 minute walk test distance between groups
Time frame: 12 weeks
Change in 6 minute walk test distance between groups
2 secondary outcomes
Change in Walking Impairment Questionnaire score
Time frame: 12 weeks
Change in VascuQOL-6 (VQ6) quality of life survey
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No. No IPD are to be shared.
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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.
Subhash Banerjee, MD, MBA principal investigator
Dallas VA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider supervision/ feedback in people with Peripheral Arterial Disease, run by Dallas VA Medical Center 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 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 27 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact McCall Walker, MD (985-381-6661, mccall.walker@phhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6 minute walk test distance between groups (time frame: 12 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 27 Jan 2022.