Peripheral Arterial Occlusive DiseaseACTIONNCT02189018
Activity To Improve Outcomes in Peripheral Arterial Disease
A study testing Active Exercise, Neuromuscular electrical stimulation and Weight loss and active exercise in people with Peripheral Arterial Occlusive Disease, run by Baltimore VA Medical Center at 1 site in United States.
Trial summary
Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- What is being tested?
- Active Exercise, Neuromuscular electrical stimulation and Weight loss and active exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 4 Jul 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-90 years
- Ankle brachial index < 0.9
Who cannot join
- Cancer under active treatment, except prostate, skin, and hematologic cancers
- Planned for open lower extremity bypass surgery
- Body mass index >45
- Lower extremity gangrene
Trial locations and contacts
1 site in 1 country.
About this study
Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project is being implemented in adults with PAD to examine the effects of exercise or weight loss programs on lower extremity blood flow, health, and physical function.
Read the detailed description
This pilot study seeks to gather data on different exercise interventions in PAD. Collectively, the proposed studies will gather data on the role of novel exercise interventions in those with PAD who are receiving conservative treatment as well as those who have undergone an endovascular intervention for lower extremity arterial disease.
We hypothesize that patients who undergo an exercise intervention will: A) show improved lower extremity perfusion and B) improve their functional ability, compared to a standard care control group over 6 months of follow-up. We further hypothesize that these improvements are mediated through angiogenesis and increased perfusion of the lower limb, as well as improvements in muscle strength, mass, and function.
- Conditions
- Peripheral Arterial Occlusive Disease
- Being tested
- Active Exercise, Neuromuscular electrical stimulation, Weight loss and active exercise, Ad lib activity at home
- Keywords
- Peripheral arterial disease, Endovascular, Exercise, Perfusion, Functional capacity
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ExerciseOther
Active exercise on a treadmill
Neuromuscular electrical stimulationOther
Neuromuscular electrical stimulation
Weight loss and active exerciseOther
Weight loss and active exercise on a treadmill
Ad lib activity at homeOther
Ad lib activity at home
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Ad lib activity at home Receives: Other: Ad lib activity at home |
| Active Exercise | Experimental | Active exercise on treadmill Receives: Other: Active Exercise |
| Neuromuscular electrical stimulation | Experimental | Neuromuscular electrical stimulation Receives: Other: Neuromuscular electrical stimulation |
| Weight loss and active exercise | Experimental | Weight loss plus active exercise on treadmill Receives: Other: Weight loss and active exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity perfusion
Ankle brachial index and ultrasound quantification of muscle perfusion
Measured: 6 months
Secondary outcomes (1)
Functional capacity
Treadmill exercise testing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startAug 2014
- Primary completion4 Jul 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Brajesh K Lal, Baltimore VA Medical Center
- Investigators
- Brajesh K Lal, MD, Principal investigator, Baltimore VAMC, University of Maryland School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189018
- Sponsor's protocol ID
- HP-00059151
- Acronym
- ACTION
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2014
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity To Improve Outcomes in Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT02189018
- Acronym / sponsor ID
- ACTION / HP-00059151
- Conditions
- Peripheral Arterial Occlusive Disease
- Keywords
- Peripheral arterial disease, Endovascular, Exercise, Perfusion, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Study start
- Aug 2014 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 14 Jul 2014 (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.
Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project is being implemented in adults with PAD to examine the effects of exercise or weight loss programs on lower extremity blood flow, health, and physical function.
Detailed description
This pilot study seeks to gather data on different exercise interventions in PAD. Collectively, the proposed studies will gather data on the role of novel exercise interventions in those with PAD who are receiving conservative treatment as well as those who have undergone an endovascular intervention for lower extremity arterial disease.
We hypothesize that patients who undergo an exercise intervention will: A) show improved lower extremity perfusion and B) improve their functional ability, compared to a standard care control group over 6 months of follow-up. We further hypothesize that these improvements are mediated through angiogenesis and increased perfusion of the lower limb, as well as improvements in muscle strength, mass, and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Ad lib activity at homeAd lib activity at home |
| Active Exercise | Experimental | Other: Active ExerciseActive exercise on treadmill |
| Neuromuscular electrical stimulation | Experimental | Other: Neuromuscular electrical stimulationNeuromuscular electrical stimulation |
| Weight loss and active exercise | Experimental | Other: Weight loss and active exerciseWeight loss plus active exercise on treadmill |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 21-90 years
- Ankle brachial index < 0.9
Key exclusion criteria (4 listed)
- Cancer under active treatment, except prostate, skin, and hematologic cancers
- Planned for open lower extremity bypass surgery
- Body mass index >45
- Lower extremity gangrene
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 |
|---|---|---|
| Active ExerciseActive exercise on a treadmill | Other | Active Exercise |
| Neuromuscular electrical stimulationNeuromuscular electrical stimulation | Other | Neuromuscular electrical stimulation |
| Weight loss and active exerciseWeight loss and active exercise on a treadmill | Other | Weight loss and active exercise |
| Ad lib activity at homeAd lib activity at home | Other | Control |
Primary outcome
Lower extremity perfusion
Time frame: 6 months
Ankle brachial index and ultrasound quantification of muscle perfusion
1 secondary outcome
Functional capacity
Time frame: 6 months
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 28 Jul 2023.
Related trials for Peripheral Arterial Occlusive Disease
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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.
Brajesh K Lal, MD principal investigator
Baltimore VAMC, University of Maryland School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Exercise, Neuromuscular electrical stimulation and Weight loss and active exercise in people with Peripheral Arterial Occlusive Disease, run by Baltimore 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 4 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 28 Jul 2023. 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?
Lower extremity perfusion (time frame: 6 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 28 Jul 2023.