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CompletedNCT01241747Updated Mar 1, 2019

Exercise for Women With Peripheral Arterial Disease

An interventional study of Walking Exercise and Control in Peripheral Artery Disease, Claudication and Women, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to female participants aged 60 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-03-01.

Sponsored by University of Oklahoma · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
60 Years to 100 Years
Sex
Female
01

Study 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. The change in peripheral vascular function will be predictive of improved exercise performance following the supervised exercise program.

02

Conditions studied

  • Peripheral Artery Disease
  • Claudication
  • Women
03

In context

Peripheral Arterial Disease

1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.

This study's enrollment of 33 is below the median of 73 across 1,078 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Browse University of Oklahoma studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Supervised Exercise

    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.

    Behavioral: Walking Exercise

  • Active comparator
    Control

    Light resistance training without any walking

    Behavioral: Control

Interventions

  • BehavioralWalking Exercise

    3 times per week for 3 months

  • BehavioralControl

    Resistance training 3 times per week for 3 months

06

What researchers measure

Primary outcomes

  1. Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain

    Time frame: 3 months

  2. Change in 6-minute walk distance

    Time frame: 3 months

Secondary outcomes

  1. Change in calf muscle oxygen saturation

    Time frame: 3 months

  2. Change in daily ambulatory activity

    Time frame: 3 months

  3. Change in walking economy

    Time frame: 3 months

  4. Change in peak oxygen uptake

    Time frame: 3 months

07

Study locations

1 site
  • Clinical Research Center, Penn State College of Medicine
    Hershey, Pennsylvania 17033, United States
08

References and documents

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 7674529 ↗
  • Gardner 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 11454114 ↗
  • Gardner 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 12042688 ↗
  • Gardner 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 14981444 ↗
  • Gardner 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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2009, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2010
First posted
Nov 16, 2010
Start
Jul 2009
Primary completionActual
Feb 2016
CompletionActual
Feb 2016
Last update
Mar 1, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01241747
Lead sponsor
University of Oklahoma
Collaborators
Oklahoma Center for the Advancement of Science and Technology, Milton S. Hershey Medical Center
Responsible party
Sponsor
First posted
Nov 16, 2010
Start date
Jul 2009
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Mar 1, 2019

Study contacts

Andrew W Gardner, PhD
principal investigator · Penn State College of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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