Intermittent ClaudicationNCT00618670
Home-based vs. Supervised Exercise for People With Claudication
A study testing Walking Exercise in people with Intermittent Claudication, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function. Read more about this study
- Who is it for?
- Ages 35 to 100 years
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- Walking Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2016
- 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 35 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive history of intermittent claudication assessed by the San Diego Claudication Questionnaire
- Exercise limited by intermittent claudication during a screening treadmill test using the Gardner protocol
- Ankle/brachial index (ABI) less than 0.90 at rest, which decreases to less than 0.73 immediately following the treadmill exercise test
Who cannot join
- Absence of PAD (peripheral artery disease)
- Asymptomatic PAD (Fontaine stage I)
- Rest pain due to PAD (Fontaine stage III)
- Tissue loss due to PAD (Fontaine stage IV)
- Medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.)
- Cognitive dysfunction (mini-mental state examination score less than 24)
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
About this study
Official title: Home-based vs. Supervised Exercise for Claudicants
The purpose of this study is to examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function.
Read the detailed description
This study seeks to 1) compare the changes in ambulatory function, vascular function, and health-related quality of life in patients limited by intermittent claudication following a home-based exercise rehabilitation program, a supervised exercise program, and a light resistance training exercise program; and 2) determine whether changes in walking efficiency, calf muscle circulation, and calf muscle oxygen are the reasons by which both home-based and supervised exercise rehabilitation improve ambulatory function.
We hypothesize that a home-based exercise program utilizing new physical activity monitoring technology that can accurately quantify exercise adherence as well as the intensity, duration, and volume of exercise sessions will result in similar changes in ambulatory function, vascular function, and health-related quality of life compared to a standard, supervised exercise program. Further, both the home-based and supervised exercise rehabilitation programs will result in greater changes in ambulatory function, vascular function, and health-related quality of life than a light resistance training exercise program. Finally, we hypothesize that the changes in walking efficiency, calf muscle circulation, and calf muscle oxygen will each be predictive of improved ambulation following the home-based exercise program as well as the supervised exercise program.
The 3-month program will consist of walking 3 times per week, with progressive increases in duration and intensity. The two walking exercise programs will be matched on the estimated caloric expenditure during the training sessions. Patients in the control group will perform light resistance training without any walking exercise.
- Conditions
- Intermittent Claudication
- Being tested
- Walking Exercise, Control--Resistance Training
- Keywords
- aging, gait, musculoskeletal disorder therapy, peripheral blood vessel disorder, muscle function, muscle strength, quality of life
- Medical subject headings
- Intermittent Claudication, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking ExerciseBehavioural
Three times per week for 3 months
Control--Resistance TrainingBehavioural
Three times per week for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Home-based program with progressive increases in exercise duration and intensity (i.e., cadence); walking duration will be longer for the home-based group because the intensity of walking will be lower than the graded treadmill walking performed by the supervised group Receives: Behavioral: Walking Exercise |
| 2 | Experimental | Supervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 70% of exercise capacity Receives: Behavioral: Walking Exercise |
| 3 | Active comparator | Light resistance training without any walking exercise Receives: Behavioral: Control--Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain
Measured: 3 months
Secondary outcomes (3)
Change in walking efficiency
Measured: 3 months
Change in calf muscle circulation and calf muscle oxygen
Measured: 3 months
Change in health-related quality of life
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startSep 2006
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma Center for the Advancement of Science and Technology, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Andrew W Gardner, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618670
- Sponsor's protocol ID
- AG0095
- Other IDs
- R01AG024296
- Status last verified
- Mar 2018
- First submitted
- 15 Feb 2008
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.
PubMed 7674529Gardner AW, Katzel LI, Sorkin JD, Bradham DD, Hochberg MC, Flinn WR, Goldberg AP. Exercise rehabilitation improves functional outcomes and peripheral circulation in patients with intermittent claudication: a randomized controlled trial. J Am Geriatr Soc. 2001 Jun;49(6):755-62. doi: 10.1046/j.1532-5415.2001.49152.x.
PubMed 11454114Gardner AW, Katzel LI, Sorkin JD, Goldberg AP. Effects of long-term exercise rehabilitation on claudication distances in patients with peripheral arterial disease: a randomized controlled trial. J Cardiopulm Rehabil. 2002 May-Jun;22(3):192-8. doi: 10.1097/00008483-200205000-00011.
PubMed 12042688Gardner AW, Killewich LA, Montgomery PS, Katzel LI. Response to exercise rehabilitation in smoking and nonsmoking patients with intermittent claudication. J Vasc Surg. 2004 Mar;39(3):531-8. doi: 10.1016/j.jvs.2003.08.037.
PubMed 14981444Gardner AW, Montgomery PS, Flinn WR, Katzel LI. The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. J Vasc Surg. 2005 Oct;42(4):702-9. doi: 10.1016/j.jvs.2005.05.049.
PubMed 16242558Gardner AW, Montgomery PS, Wang M, Liang M. Effects of Long-Term Home Exercise in Participants With Peripheral Artery Disease. J Am Heart Assoc. 2023 Nov 7;12(21):e029755. doi: 10.1161/JAHA.122.029755. Epub 2023 Nov 6.
PubMed 37929770Gardner AW, Parker DE, Montgomery PS. Changes in vascular and inflammatory biomarkers after exercise rehabilitation in patients with symptomatic peripheral artery disease. J Vasc Surg. 2019 Oct;70(4):1280-1290. doi: 10.1016/j.jvs.2018.12.056. Epub 2019 Mar 25.
PubMed 30922751Gardner AW, Parker DE, Montgomery PS. Predictors of Improved Walking after a Supervised Walking Exercise Program in Men and Women with Peripheral Artery Disease. Int J Vasc Med. 2016;2016:2191350. doi: 10.1155/2016/2191350. Epub 2016 Dec 25.
PubMed 28116164Gardner AW, Parker DE, Montgomery PS. Sex-specific predictors of improved walking with step-monitored, home-based exercise in peripheral artery disease. Vasc Med. 2015 Oct;20(5):424-31. doi: 10.1177/1358863X15596237. Epub 2015 Aug 3.
PubMed 26240075Gardner AW, Parker DE, Montgomery PS, Blevins SM. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J Am Heart Assoc. 2014 Sep 18;3(5):e001107. doi: 10.1161/JAHA.114.001107.
PubMed 25237048Gardner AW, Alaupovic P, Parker DE, Montgomery PS, Esponda OL, Casanegra AI. Influence of peripheral artery disease and statin therapy on apolipoprotein profiles. Int J Vasc Med. 2013;2013:548764. doi: 10.1155/2013/548764. Epub 2013 Sep 11.
PubMed 24102029Gardner AW, Parker DE, Montgomery PS, Scott KJ, Blevins SM. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation. 2011 Feb 8;123(5):491-8. doi: 10.1161/CIRCULATIONAHA.110.963066. Epub 2011 Jan 24.
PubMed 21262997
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based vs. Supervised Exercise for Claudicants
- ClinicalTrials.gov ID
- NCT00618670
- Acronym / sponsor ID
- AG0095
- Conditions
- Intermittent Claudication
- Keywords
- aging, gait, musculoskeletal disorder therapy, peripheral blood vessel disorder, muscle function, muscle strength, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma Center for the Advancement of Science and Technology, National Institute on Aging (NIA)
- Study start
- Sep 2006
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Feb 2008 (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 examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function.
Detailed description
This study seeks to 1) compare the changes in ambulatory function, vascular function, and health-related quality of life in patients limited by intermittent claudication following a home-based exercise rehabilitation program, a supervised exercise program, and a light resistance training exercise program; and 2) determine whether changes in walking efficiency, calf muscle circulation, and calf muscle oxygen are the reasons by which both home-based and supervised exercise rehabilitation improve ambulatory function.
We hypothesize that a home-based exercise program utilizing new physical activity monitoring technology that can accurately quantify exercise adherence as well as the intensity, duration, and volume of exercise sessions will result in similar changes in ambulatory function, vascular function, and health-related quality of life compared to a standard, supervised exercise program. Further, both the home-based and supervised exercise rehabilitation programs will result in greater changes in ambulatory function, vascular function, and health-related quality of life than a light resistance training exercise program. Finally, we hypothesize that the changes in walking efficiency, calf muscle circulation, and calf muscle oxygen will each be predictive of improved ambulation following the home-based exercise program as well as the supervised exercise program.
The 3-month program will consist of walking 3 times per week, with progressive increases in duration and intensity. The two walking exercise programs will be matched on the estimated caloric expenditure during the training sessions. Patients in the control group will perform light resistance training without any walking exercise.
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: Walking ExerciseHome-based program with progressive increases in exercise duration and intensity (i.e., cadence); walking duration will be longer for the home-based group because the intensity of walking will be lower than the graded treadmill walking performed by the supervised group |
| 2 | Experimental | Behavioral: Walking ExerciseSupervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 70% of exercise capacity |
| 3 | Active comparator | Behavioral: Control--Resistance TrainingLight resistance training without any walking exercise |
Who may qualify
- Ages
- 35 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Positive history of intermittent claudication assessed by the San Diego Claudication Questionnaire
- Exercise limited by intermittent claudication during a screening treadmill test using the Gardner protocol
- Ankle/brachial index (ABI) less than 0.90 at rest, which decreases to less than 0.73 immediately following the treadmill exercise test
Key exclusion criteria (6 listed)
- Absence of PAD (peripheral artery disease)
- Asymptomatic PAD (Fontaine stage I)
- Rest pain due to PAD (Fontaine stage III)
- Tissue loss due to PAD (Fontaine stage IV)
- Medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, 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 |
|---|---|---|
| Walking ExerciseThree times per week for 3 months | Behavioural | 1, 2 |
| Control--Resistance TrainingThree times per week for 3 months | Behavioural | 3 |
Primary outcome
Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain
Time frame: 3 months
3 secondary outcomes
Change in walking efficiency
Time frame: 3 months
Change in calf muscle circulation and calf muscle oxygen
Time frame: 3 months
Change in health-related quality of life
Time frame: 3 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 2 Apr 2018.
- Background: PubMed 7674529Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.
- Background: PubMed 11454114Gardner AW, Katzel LI, Sorkin JD, Bradham DD, Hochberg MC, Flinn WR, Goldberg AP. Exercise rehabilitation improves functional outcomes and peripheral circulation in patients with intermittent claudication: a randomized controlled trial. J Am Geriatr Soc. 2001 Jun;49(6):755-62. doi: 10.1046/j.1532-5415.2001.49152.x.
- Background: PubMed 12042688Gardner AW, Katzel LI, Sorkin JD, Goldberg AP. Effects of long-term exercise rehabilitation on claudication distances in patients with peripheral arterial disease: a randomized controlled trial. J Cardiopulm Rehabil. 2002 May-Jun;22(3):192-8. doi: 10.1097/00008483-200205000-00011.
- Background: PubMed 14981444Gardner AW, Killewich LA, Montgomery PS, Katzel LI. Response to exercise rehabilitation in smoking and nonsmoking patients with intermittent claudication. J Vasc Surg. 2004 Mar;39(3):531-8. doi: 10.1016/j.jvs.2003.08.037.
- Background: PubMed 16242558Gardner AW, Montgomery PS, Flinn WR, Katzel LI. The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. J Vasc Surg. 2005 Oct;42(4):702-9. doi: 10.1016/j.jvs.2005.05.049.
- Derived from this study: PubMed 37929770Gardner AW, Montgomery PS, Wang M, Liang M. Effects of Long-Term Home Exercise in Participants With Peripheral Artery Disease. J Am Heart Assoc. 2023 Nov 7;12(21):e029755. doi: 10.1161/JAHA.122.029755. Epub 2023 Nov 6.
- Derived from this study: PubMed 30922751Gardner AW, Parker DE, Montgomery PS. Changes in vascular and inflammatory biomarkers after exercise rehabilitation in patients with symptomatic peripheral artery disease. J Vasc Surg. 2019 Oct;70(4):1280-1290. doi: 10.1016/j.jvs.2018.12.056. Epub 2019 Mar 25.
- Derived from this study: PubMed 28116164Gardner AW, Parker DE, Montgomery PS. Predictors of Improved Walking after a Supervised Walking Exercise Program in Men and Women with Peripheral Artery Disease. Int J Vasc Med. 2016;2016:2191350. doi: 10.1155/2016/2191350. Epub 2016 Dec 25.
- Derived from this study: PubMed 26240075Gardner AW, Parker DE, Montgomery PS. Sex-specific predictors of improved walking with step-monitored, home-based exercise in peripheral artery disease. Vasc Med. 2015 Oct;20(5):424-31. doi: 10.1177/1358863X15596237. Epub 2015 Aug 3.
- Derived from this study: PubMed 25237048Gardner AW, Parker DE, Montgomery PS, Blevins SM. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J Am Heart Assoc. 2014 Sep 18;3(5):e001107. doi: 10.1161/JAHA.114.001107.
- Derived from this study: PubMed 24102029Gardner AW, Alaupovic P, Parker DE, Montgomery PS, Esponda OL, Casanegra AI. Influence of peripheral artery disease and statin therapy on apolipoprotein profiles. Int J Vasc Med. 2013;2013:548764. doi: 10.1155/2013/548764. Epub 2013 Sep 11.
- Derived from this study: PubMed 21262997Gardner AW, Parker DE, Montgomery PS, Scott KJ, Blevins SM. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation. 2011 Feb 8;123(5):491-8. doi: 10.1161/CIRCULATIONAHA.110.963066. Epub 2011 Jan 24.
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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.
Andrew W Gardner, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking Exercise in people with Intermittent Claudication, run by University of Oklahoma 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 3 inclusion and 6 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 2 Apr 2018. 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?
Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain (time frame: 3 months). 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 NCT00618670, which also lists 12 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 2 Apr 2018.