Peripheral Artery DiseaseNCT01241747
Exercise for Women With Peripheral Arterial Disease
A study testing Walking Exercise in people with Peripheral Artery Disease and Claudication, run by University of Oklahoma at 1 site in United States.
Trial summary
Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in exercise performance, peripheral vascular function, and health-related quality of life than compared to the attention-control group. Hypothesis #2. Read more about this study
- Who is it for?
- Ages 60 to 100 years, women only
- Conditions the study is for
- Peripheral Artery Disease, Claudication, Women
- 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
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Feb 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 60 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women 60 years of age and older having a 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
- an ankle/brachial index (ABI) < 0.90 at rest or < 0.73 immediately following the treadmill exercise test
- at least one year past menopause
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.)
- use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation)
Show all 10Show fewer
- cognitive dysfunction (mini-mental state examination score < 24)
- active cancer, renal disease, or liver disease
- a calf skin fold measurement > 50 mm, because of potential interference with the light path of the near-infrared spectroscopy probe from penetrating the subcutaneous tissue
- pulse arterial oxygen saturation of the index finger < 95% because of the potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center, Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in exercise performance, peripheral vascular function, and health-related quality of life than compared to the attention-control group.
Hypothesis #2. The change in peripheral vascular function will be predictive of improved exercise performance following the supervised exercise program.
- Conditions
- Peripheral Artery Disease, Claudication, Women
- Being tested
- Walking Exercise, Control
- 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.
Walking ExerciseBehavioural
3 times per week for 3 months
ControlBehavioural
Resistance training 3 times per week for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise | Experimental | Supervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes at an exercise intensity of 40% of exercise capacity. Receives: Behavioral: Walking Exercise |
| Control | Active comparator | Light resistance training without any walking Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain
Measured: 3 months
Change in 6-minute walk distance
Measured: 3 months
Secondary outcomes (4)
Change in calf muscle oxygen saturation
Measured: 3 months
Change in daily ambulatory activity
Measured: 3 months
Change in walking economy
Measured: 3 months
Change in peak oxygen uptake
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 posted16 Nov 2010 (estimated)
- Study startJul 2009
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- 33 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, Milton S. Hershey Medical Center
- Responsible party
- Sponsor
- Investigators
- Andrew W Gardner, PhD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241747
- Sponsor's protocol ID
- HR09-035
- Status last verified
- Feb 2019
- First submitted
- 15 Nov 2010
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
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 16242558
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise for Women With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT01241747
- Acronym / sponsor ID
- HR09-035
- Conditions
- Peripheral Artery Disease, Claudication, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma Center for the Advancement of Science and Technology, Milton S. Hershey Medical Center
- Study start
- Jul 2009
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Nov 2010 (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.
Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in exercise performance, peripheral vascular function, and health-related quality of life than compared to the attention-control group.
Hypothesis #2. The change in peripheral vascular function will be predictive of improved exercise performance following the supervised exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise | Experimental | Behavioral: Walking ExerciseSupervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes at an exercise intensity of 40% of exercise capacity. |
| Control | Active comparator | Behavioral: ControlLight resistance training without any walking |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women 60 years of age and older having a 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
- an ankle/brachial index (ABI) < 0.90 at rest or < 0.73 immediately following the treadmill exercise test
- at least one year past menopause
Key exclusion criteria (10 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 Exercise3 times per week for 3 months | Behavioural | Supervised Exercise |
| ControlResistance training 3 times per week for 3 months | Behavioural | Control |
Primary outcome
Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain
Time frame: 3 months
Change in 6-minute walk distance
Time frame: 3 months
4 secondary outcomes
Change in calf muscle oxygen saturation
Time frame: 3 months
Change in daily ambulatory activity
Time frame: 3 months
Change in walking economy
Time frame: 3 months
Change in peak oxygen uptake
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 1 Mar 2019.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
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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
Penn State College 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 Walking Exercise in people with Peripheral Artery Disease and 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 4 inclusion and 10 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 1 Mar 2019. 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 walking distance to onset of leg pain and the change in walking distance to maximal leg pain (time frame: 3 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?
On the ClinicalTrials.gov record for NCT01241747, which also lists 5 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 1 Mar 2019.