Cardiovascular DiseasesNCT00106327
Improving Functioning in Peripheral Arterial Disease
A study testing Exercise and Diet in people with Cardiovascular Diseases and Peripheral Vascular Diseases, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of nutrition, a supervised treadmill exercise program, and supervised progressive resistance training program on peripheral arterial disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Peripheral Vascular Diseases
- What is being tested?
- Exercise and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Mar 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 150 peripheral arterial disease patients with and without IC
Who cannot join
- Below or above-knee amputation
- Wheelchair confinement
- Inability to walk on a treadmill or inability to perform progressive resistance training
- Inability to return to the medical center three times weekly for 6 months
- Walking impairment due to a cause other than PAD
- Class II New York Heart Association (NYHA) heart failure or angina (heart failure or angina occurring at rest or with minimal exertion)
Show all 22Show fewer
- Planned lower extremity revascularization or any other major surgery within 12 months
- Any increase in anginal symptoms during the previous 6 months or angina at rest
- Subjects with silent coronary ischemia, defined as ST segment depression greater than or equal to 1 mm during baseline exercise treadmill test without associated chest discomfort, unless they have had a normal perfusion stress test during the previous 6 months
- Subjects with left-bundle branch block or significant ST-T wave changes on their baseline ECG who do not have a perfusion stress test demonstrating absence of reversible ischemia within the previous 6 months
- Lower extremity revascularization, major orthopedic surgery, or other major surgery during the previous 3 months
- Myocardial infarction or coronary artery bypass grafting during the previous 3 months
- Major medical illnesses that may interfere with subject's ability to complete the interventions and/or follow-up testing
- Current foot ulcer
- ABI greater than 0.95
- Life expectancy less than 12 months
- Does not speak English
- Patient is currently involved in another clinical trial
- Dementia
- Poorly controlled blood pressure
- Current significant exercise, defined as exercising three times weekly for 30 minutes with sufficient exertion to produce a sweat or other exercise that is comparable to the exercise interventions offered in our protocol
- Treatment for cancer (other than non-melanoma skin cancer) during the past 12 months (including radiation therapy, chemotherapy, or surgery)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611-3008
About this study
The purpose of this study is to compare the effects of nutrition, a supervised treadmill exercise program, and supervised progressive resistance training program on peripheral arterial disease.
Read the detailed description
BACKGROUND:
Previous work demonstrates that functional limitations associated with peripheral arterial disease (PAD) are diverse and include slower walking speed, poorer walking endurance, and impaired balance as compared to persons without PAD. Although treadmill-walking exercise improves treadmill performance in patients with intermittent claudication (IC), treadmill performance does not correlate well with community walking ability in older men and women. In older patient populations without PAD, resistance training improves functioning and walking endurance, but this mode of exercise has not been sufficiently studied in PAD. Furthermore, although 65% to 70% of men and women with PAD are either asymptomatic or have exertional leg symptoms other than IC, no prior studies have assessed the effects of exercise interventions in PAD patients who do not have IC.
DESIGN NARRATIVE:
The randomized, control study will determine whether a 6-month supervised treadmill exercise program and a supervised lower extremity progressive resistance training program, respectively, improve lower extremity functioning compared to a nutrition control group among 150 PAD patients with and without IC. The investigators hypothesize that participants in the treadmill walking exercise program and participants in the progressive resistance training program, respectively, will experience greater improvement in functional outcomes than participants in the nutrition control group. The primary functional outcome measures in descending order of importance are 6-minute walk distance and the summary performance score. The summary performance score is a composite measure of lower extremity functioning (usual walking speed, standing balance, and time required for five repeated chair rises) measured on a 0-12 scale that predicts future risk of nursing home placement, mobility loss, and mortality. The study will also identify mechanisms by which the exercise interventions improve functioning in PAD. Mechanisms to be studied include changes in blood viscosity, calf blood flow, brachial artery endothelial reactivity, and inflammatory cytokine levels. By identifying the optimal exercise program for improving functioning in PAD patients with and without IC, the findings will have substantial clinical and public health implications for millions of patients with PAD.
- Being tested
- Exercise, Diet
- Medical subject headings
- Cardiovascular Diseases, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
6 months of supervised treadmill exercise or strength training, three times per week, followed by a 6 month home-based program.
DietBehavioural
11 nutrition education sessions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 6-month supervised treadmill exercise program Receives: Behavioral: Exercise |
| 2 | Experimental | 6-month supervised lower extremity progressive resistance training program Receives: Behavioral: Exercise |
| 3 | Active comparator | Diet/nutrition control group Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk distance
Measured: Measured at baseline and follow-up study visits
Summary performance score
Measured: Measured at baseline and follow-up study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2005 (estimated)
- Study startSep 2003
- Primary completionJul 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mary McDermott, Northwestern University
- Investigators
- Mary McDermott, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106327
- Sponsor's protocol ID
- 171
- Other IDs
- R01HL073351
- Status last verified
- Jul 2012
- First submitted
- 22 Mar 2005
- Last updated
- 25 Jul 2012
- Results posted
- No
Publications
Hammond MM, Tian L, Zhao L, Zhang D, McDermott MM. Attendance at Supervised Exercise Sessions and Walking Outcomes in Peripheral Artery Disease: Results From 2 Randomized Clinical Trials. J Am Heart Assoc. 2022 Dec 20;11(24):e026136. doi: 10.1161/JAHA.122.026136. Epub 2022 Dec 19.
PubMed 36533626McDermott MM, Tian L, Criqui MH, Ferrucci L, Greenland P, Guralnik JM, Kibbe MR, Li L, Sufit R, Zhao L, Polonsky TS. Perceived Versus Objective Change in Walking Ability in Peripheral Artery Disease: Results from 3 Randomized Clinical Trials of Exercise Therapy. J Am Heart Assoc. 2021 Jun 15;10(12):e017609. doi: 10.1161/JAHA.120.017609. Epub 2021 Jun 2.
PubMed 34075780Patel K, Polonsky TS, Kibbe MR, Guralnik JM, Tian L, Ferrucci L, Criqui MH, Sufit R, Leeuwenburgh C, Zhang D, Zhao L, McDermott MM. Clinical characteristics and response to supervised exercise therapy of people with lower extremity peripheral artery disease. J Vasc Surg. 2021 Feb;73(2):608-625. doi: 10.1016/j.jvs.2020.04.498. Epub 2020 May 19.
PubMed 32416309McDermott MM, Kibbe MR, Guralnik JM, Ferrucci L, Criqui MH, Domanchuk K, Tian L, Zhao L, Li L, Patel K, Polonsky TS. Durability of Benefits From Supervised Treadmill Exercise in People With Peripheral Artery Disease. J Am Heart Assoc. 2019 Jan 8;8(1):e009380. doi: 10.1161/JAHA.118.009380.
PubMed 30587066McDermott MM, Ferrucci L, Guralnik JM, Dyer AR, Liu K, Pearce WH, Clark E, Liao Y, Criqui MH. The ankle-brachial index is associated with the magnitude of impaired walking endurance among men and women with peripheral arterial disease. Vasc Med. 2010 Aug;15(4):251-7. doi: 10.1177/1358863X10365181. Epub 2010 May 28.
PubMed 20511294Payvandi L, Dyer A, McPherson D, Ades P, Stein J, Liu K, Ferrucci L, Criqui MH, Guralnik JM, Lloyd-Jones D, Kibbe MR, Liang ST, Kane B, Pearce WH, Verta M, McCarthy WJ, Schneider JR, Shroff A, McDermott MM. Physical activity during daily life and brachial artery flow-mediated dilation in peripheral arterial disease. Vasc Med. 2009 Aug;14(3):193-201. doi: 10.1177/1358863X08101018.
PubMed 19651668McDermott MM, Ades P, Guralnik JM, Dyer A, Ferrucci L, Liu K, Nelson M, Lloyd-Jones D, Van Horn L, Garside D, Kibbe M, Domanchuk K, Stein JH, Liao Y, Tao H, Green D, Pearce WH, Schneider JR, McPherson D, Laing ST, McCarthy WJ, Shroff A, Criqui MH. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. JAMA. 2009 Jan 14;301(2):165-74. doi: 10.1001/jama.2008.962.
PubMed 19141764McDermott MM, Ades PA, Dyer A, Guralnik JM, Kibbe M, Criqui MH. Corridor-based functional performance measures correlate better with physical activity during daily life than treadmill measures in persons with peripheral arterial disease. J Vasc Surg. 2008 Nov;48(5):1231-7, 1237.e1. doi: 10.1016/j.jvs.2008.06.050. Epub 2008 Oct 1.
PubMed 18829215
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Functioning in Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT00106327
- Acronym / sponsor ID
- 171
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 Mar 2005 (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.
The purpose of this study is to compare the effects of nutrition, a supervised treadmill exercise program, and supervised progressive resistance training program on peripheral arterial disease.
Detailed description
BACKGROUND:
Previous work demonstrates that functional limitations associated with peripheral arterial disease (PAD) are diverse and include slower walking speed, poorer walking endurance, and impaired balance as compared to persons without PAD. Although treadmill-walking exercise improves treadmill performance in patients with intermittent claudication (IC), treadmill performance does not correlate well with community walking ability in older men and women. In older patient populations without PAD, resistance training improves functioning and walking endurance, but this mode of exercise has not been sufficiently studied in PAD. Furthermore, although 65% to 70% of men and women with PAD are either asymptomatic or have exertional leg symptoms other than IC, no prior studies have assessed the effects of exercise interventions in PAD patients who do not have IC.
DESIGN NARRATIVE:
The randomized, control study will determine whether a 6-month supervised treadmill exercise program and a supervised lower extremity progressive resistance training program, respectively, improve lower extremity functioning compared to a nutrition control group among 150 PAD patients with and without IC. The investigators hypothesize that participants in the treadmill walking exercise program and participants in the progressive resistance training program, respectively, will experience greater improvement in functional outcomes than participants in the nutrition control group. The primary functional outcome measures in descending order of importance are 6-minute walk distance and the summary performance score. The summary performance score is a composite measure of lower extremity functioning (usual walking speed, standing balance, and time required for five repeated chair rises) measured on a 0-12 scale that predicts future risk of nursing home placement, mobility loss, and mortality. The study will also identify mechanisms by which the exercise interventions improve functioning in PAD. Mechanisms to be studied include changes in blood viscosity, calf blood flow, brachial artery endothelial reactivity, and inflammatory cytokine levels. By identifying the optimal exercise program for improving functioning in PAD patients with and without IC, the findings will have substantial clinical and public health implications for millions of patients with PAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Exercise6-month supervised treadmill exercise program |
| 2 | Experimental | Behavioral: Exercise6-month supervised lower extremity progressive resistance training program |
| 3 | Active comparator | Behavioral: DietDiet/nutrition control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 150 peripheral arterial disease patients with and without IC
Key exclusion criteria (22 listed)
- Below or above-knee amputation
- Wheelchair confinement
- Inability to walk on a treadmill or inability to perform progressive resistance training
- Inability to return to the medical center three times weekly for 6 months
- Walking impairment due to a cause 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 |
|---|---|---|
| Exercise6 months of supervised treadmill exercise or strength training, three times per week, followed by a 6 month home-based program. | Behavioural | 1, 2 |
| Diet11 nutrition education sessions | Behavioural | 3 |
Primary outcome
Six-minute walk distance
Time frame: Measured at baseline and follow-up study visits
Summary performance score
Time frame: Measured at baseline and follow-up study visits
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 25 Jul 2012.
- Derived from this study: PubMed 36533626Hammond MM, Tian L, Zhao L, Zhang D, McDermott MM. Attendance at Supervised Exercise Sessions and Walking Outcomes in Peripheral Artery Disease: Results From 2 Randomized Clinical Trials. J Am Heart Assoc. 2022 Dec 20;11(24):e026136. doi: 10.1161/JAHA.122.026136. Epub 2022 Dec 19.
- Derived from this study: PubMed 34075780McDermott MM, Tian L, Criqui MH, Ferrucci L, Greenland P, Guralnik JM, Kibbe MR, Li L, Sufit R, Zhao L, Polonsky TS. Perceived Versus Objective Change in Walking Ability in Peripheral Artery Disease: Results from 3 Randomized Clinical Trials of Exercise Therapy. J Am Heart Assoc. 2021 Jun 15;10(12):e017609. doi: 10.1161/JAHA.120.017609. Epub 2021 Jun 2.
- Derived from this study: PubMed 32416309Patel K, Polonsky TS, Kibbe MR, Guralnik JM, Tian L, Ferrucci L, Criqui MH, Sufit R, Leeuwenburgh C, Zhang D, Zhao L, McDermott MM. Clinical characteristics and response to supervised exercise therapy of people with lower extremity peripheral artery disease. J Vasc Surg. 2021 Feb;73(2):608-625. doi: 10.1016/j.jvs.2020.04.498. Epub 2020 May 19.
- Derived from this study: PubMed 30587066McDermott MM, Kibbe MR, Guralnik JM, Ferrucci L, Criqui MH, Domanchuk K, Tian L, Zhao L, Li L, Patel K, Polonsky TS. Durability of Benefits From Supervised Treadmill Exercise in People With Peripheral Artery Disease. J Am Heart Assoc. 2019 Jan 8;8(1):e009380. doi: 10.1161/JAHA.118.009380.
- Derived from this study: PubMed 20511294McDermott MM, Ferrucci L, Guralnik JM, Dyer AR, Liu K, Pearce WH, Clark E, Liao Y, Criqui MH. The ankle-brachial index is associated with the magnitude of impaired walking endurance among men and women with peripheral arterial disease. Vasc Med. 2010 Aug;15(4):251-7. doi: 10.1177/1358863X10365181. Epub 2010 May 28.
- Derived from this study: PubMed 19651668Payvandi L, Dyer A, McPherson D, Ades P, Stein J, Liu K, Ferrucci L, Criqui MH, Guralnik JM, Lloyd-Jones D, Kibbe MR, Liang ST, Kane B, Pearce WH, Verta M, McCarthy WJ, Schneider JR, Shroff A, McDermott MM. Physical activity during daily life and brachial artery flow-mediated dilation in peripheral arterial disease. Vasc Med. 2009 Aug;14(3):193-201. doi: 10.1177/1358863X08101018.
- Derived from this study: PubMed 19141764McDermott MM, Ades P, Guralnik JM, Dyer A, Ferrucci L, Liu K, Nelson M, Lloyd-Jones D, Van Horn L, Garside D, Kibbe M, Domanchuk K, Stein JH, Liao Y, Tao H, Green D, Pearce WH, Schneider JR, McPherson D, Laing ST, McCarthy WJ, Shroff A, Criqui MH. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. JAMA. 2009 Jan 14;301(2):165-74. doi: 10.1001/jama.2008.962.
- Derived from this study: PubMed 18829215McDermott MM, Ades PA, Dyer A, Guralnik JM, Kibbe M, Criqui MH. Corridor-based functional performance measures correlate better with physical activity during daily life than treadmill measures in persons with peripheral arterial disease. J Vasc Surg. 2008 Nov;48(5):1231-7, 1237.e1. doi: 10.1016/j.jvs.2008.06.050. Epub 2008 Oct 1.
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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.
Mary McDermott, MD principal investigator
Northwestern University
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 Diet in people with Cardiovascular Diseases and Peripheral Vascular Diseases, run by Northwestern University 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 1 inclusion and 22 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 25 Jul 2012. 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 distance (time frame: Measured at baseline and follow-up study visits). 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?
On the ClinicalTrials.gov record for NCT00106327, which also lists 8 linked publications.
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 25 Jul 2012.