Peripheral Arterial DiseaseAction3NCT02607033
Exercise and Weight Loss in PAD
A study testing Exercise and Weight Loss in people with Peripheral Arterial Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study is designed to examine the added benefits of weight loss to an exercise program in older obese Veterans with peripheral arterial disease. The investigators want to determine if weight loss in addition to exercise will 1) improve walking ability to a greater extent than exercise alone and 2) determine the… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Exercise and Weight Loss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >25 kg/m2
- Ankle Brachial Index (ABI) <.90
- Able to participate in a supervised exercise program at the Baltimore VA
- No current plan for surgical revascularization
- Claudication or leg symptoms when walking
Who cannot join
- Unstable angina or a recent heart attack
- Active cancer
- Dementia
- Current foot or leg ulcers
- Already exercise 2x/week or more.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: Exercise and Weight Loss to Improve Mobility Function in Veterans With PAD
This study is designed to examine the added benefits of weight loss to an exercise program in older obese Veterans with peripheral arterial disease. The investigators want to determine if weight loss in addition to exercise will 1) improve walking ability to a greater extent than exercise alone and 2) determine the underlying reasons why walking ability improves by measuring blood flow and the amount of muscle in the leg muscles.
Read the detailed description
Peripheral artery disease (PAD) affects an estimated 12 -15 million adults in the US and an estimated 20% of older Veterans. Those with PAD ambulate with slow gait and experience decreased leg strength, dysmobility, reduced quality of life, serious morbidity and often premature death. It is estimated that over 60% of individuals with PAD are overweight or obese. While PAD itself worsens mobility, obesity adds a further functional burden to older adults with PAD. Individuals diagnosed with PAD, who are also obese typically claudicate 40% more quickly than non-obese individuals and take 20% longer to recover after claudication. Studies of older obese adults without PAD have demonstrated that the combination of exercise and weight loss is more effective at improving physical function and body composition than exercise alone. While these findings likely translate to older adults with PAD, this hypothesis has yet to be tested. This study is designed to determine whether weight loss and exercise (WL+EX) versus exercise ( EX ) alone will 1) improve mobility function (walking ability) to a greater extent than exercise alone and 2) determine the mechanisms underlying changes in mobility function by measuring muscle microvascular perfusion and composition. The investigators hypothesize that a combined intervention of weight loss and exercise (aerobic and restive) will result in greater improvements in mobility function through improved muscle perfusion and reduced muscle fat infiltration than exercise alone in obese Veterans with PAD.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Exercise, Weight Loss
- Keywords
- Exercise, Weight Loss, Mobility Limitation
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity, Weight Loss, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
Weight LossOther
Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Weight Loss | Experimental | Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months Receives: Other: Exercise; Other: Weight Loss |
| Exercise | Active comparator | Individuals assigned to this group will be asked to complete the exercise intervention for xic months Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Time to Onset of Calf Pain (Claudication Onset Time) Pre-intervention to Post-intervention
The change in the amount of time it takes for calf pain to first appear while walking on a treadmill comparing pre and post-intervention
Measured: 6 months
Difference in Ankle Brachial Index Pre-intervention to Post-intervention
A change in the muscle blood flow to the legs determined by taking blood pressure in the arms and legs before and after cessation of exercise comparing the change pre to post exercise scores pre-intervention (baseline) and post intervention (6 months). There are no units because the ankle brachial index is a ratio. An improvement would be a higher number a post-intervention testing than pre-intervention testing. A negative number indicates improvement while a positive number indicates a worse score post-testing.
Measured: 6 months
Secondary outcomes (2)
Score on the Modified Physical Performance Test Post-intervention
A mobility measure that utilizes 9 tasks scored 0-4 (total possible score 36) to determine functional status. Scores from each of the nine items are summed for the total score. Scores are from 0-36 with higher scores considered to be better. The post-testing median score will be reported for post-testing.
Measured: 6 months
Change in Muscle Composition of the Calf Muscles Pre-intervention to Post-intervention
A measure of the amount of muscle and fat in the muscle using a CT scan of the legs. Pre-test levels will be compared to post-test levels.
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 posted17 Nov 2015 (estimated)
- Study start1 Oct 2015
- Primary completion1 Jun 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Odessa R. Addison, PhD DPT, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607033
- Sponsor's protocol ID
- E1788-W
- Other IDs
- IK2RX001788-01
- Acronym
- Action3
- Status last verified
- Jan 2024
- First submitted
- 13 Nov 2015
- Last updated
- 17 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Weight Loss to Improve Mobility Function in Veterans With PAD
- ClinicalTrials.gov ID
- NCT02607033
- Acronym / sponsor ID
- Action3 / E1788-W
- Conditions
- Peripheral Arterial Disease
- Keywords
- Exercise, Weight Loss, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Posted 17 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to examine the added benefits of weight loss to an exercise program in older obese Veterans with peripheral arterial disease. The investigators want to determine if weight loss in addition to exercise will 1) improve walking ability to a greater extent than exercise alone and 2) determine the underlying reasons why walking ability improves by measuring blood flow and the amount of muscle in the leg muscles.
Detailed description
Peripheral artery disease (PAD) affects an estimated 12 -15 million adults in the US and an estimated 20% of older Veterans. Those with PAD ambulate with slow gait and experience decreased leg strength, dysmobility, reduced quality of life, serious morbidity and often premature death. It is estimated that over 60% of individuals with PAD are overweight or obese. While PAD itself worsens mobility, obesity adds a further functional burden to older adults with PAD. Individuals diagnosed with PAD, who are also obese typically claudicate 40% more quickly than non-obese individuals and take 20% longer to recover after claudication. Studies of older obese adults without PAD have demonstrated that the combination of exercise and weight loss is more effective at improving physical function and body composition than exercise alone. While these findings likely translate to older adults with PAD, this hypothesis has yet to be tested. This study is designed to determine whether weight loss and exercise (WL+EX) versus exercise ( EX ) alone will 1) improve mobility function (walking ability) to a greater extent than exercise alone and 2) determine the mechanisms underlying changes in mobility function by measuring muscle microvascular perfusion and composition. The investigators hypothesize that a combined intervention of weight loss and exercise (aerobic and restive) will result in greater improvements in mobility function through improved muscle perfusion and reduced muscle fat infiltration than exercise alone in obese Veterans with PAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and Weight Loss | Experimental | Other: Exercise, Other: Weight LossIndividuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months |
| Exercise | Active comparator | Other: ExerciseIndividuals assigned to this group will be asked to complete the exercise intervention for xic months |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI >25 kg/m2
- Ankle Brachial Index (ABI) <.90
- Able to participate in a supervised exercise program at the Baltimore VA
- No current plan for surgical revascularization
- Claudication or leg symptoms when walking
Key exclusion criteria (5 listed)
- Unstable angina or a recent heart attack
- Active cancer
- Dementia
- Current foot or leg ulcers
- Already exercise 2x/week or more.
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 |
|---|---|---|
| ExerciseIndividuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs. | Other | Exercise, Exercise and Weight Loss |
| Weight LossIndividuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months. | Other | Exercise and Weight Loss |
Primary outcome
Difference in Time to Onset of Calf Pain (Claudication Onset Time) Pre-intervention to Post-intervention
Time frame: 6 months
The change in the amount of time it takes for calf pain to first appear while walking on a treadmill comparing pre and post-intervention
Difference in Ankle Brachial Index Pre-intervention to Post-intervention
Time frame: 6 months
A change in the muscle blood flow to the legs determined by taking blood pressure in the arms and legs before and after cessation of exercise comparing the change pre to post exercise scores pre-intervention (baseline) and post intervention (6 months). There are no units because the ankle brachial index is a ratio. An improvement would be a higher number a post-intervention testing than pre-intervention testing. A negative number indicates improvement while a positive number indicates a worse score post-testing.
2 secondary outcomes
Score on the Modified Physical Performance Test Post-intervention
Time frame: 6 months
Change in Muscle Composition of the Calf Muscles Pre-intervention to Post-intervention
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Odessa R. Addison, PhD DPT principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Weight Loss in people with Peripheral Arterial Disease, run by VA Office of Research and Development 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 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 17 Jun 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?
Yes. Results are posted in the registry (first posted 17 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Time to Onset of Calf Pain (Claudication Onset Time) Pre-intervention to Post-intervention (time frame: 6 months). 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 17 Jun 2024.