COMPLETED

Static Muscular Stretching for Treatment of PAD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Therefore, the purpose of this study is to determine whether prescriptive muscle stretching improves muscle oxygenation and walking ability in PAD patients. This is a single-blinded study in 40 patients with stable symptomatic PAD. Patients assigned to the stretch group will use ankle splints (both legs) to perform static muscle stretching for 4 weeks (ankle dorsiflexion applied 30 min/d, 5 days/wk). Patients assigned to the control group will also wear the ankle splints daily but without invoking any dorsiflexion, i.e., without stretching. Measurements will consist of ankle-brachial index (ABI) at rest and post-exercise, skeletal muscle oxygenation (evaluated with near-infrared spectroscopy (NIRS)), and 6 minute walk test (6MWT), performed at baseline and after 4 weeks of stretching (or control splint placement). In addition, NIRS will be used to evaluate muscle oxygenation while patients are wearing the splint device in order to quantitatively prescribe the angle of dorsiflexion that provides optimum stretch and deoxygenation of the calf muscles without causing pain. Primary outcomes include increased muscle oxygenation during exercise and walking distance after 4 weeks of static muscle stretching. Results from this study will be used to support funding applications for a larger efficacy trial.

Official Title

Static Muscular Stretching for Treatment of Peripheral Artery Disease

Quick Facts

Study Start:2020-07-29
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04222751

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 40+
  2. * A resting ankle-brachial index (ABI) of 0.90 or less in either leg
  3. * Stable disease (PAD) for a minimum of 3-months
  1. * Habitual exercise (30 minutes of continuous activity for 3 or more days per week)
  2. * Cardiovascular rehabilitation program during the past 3 months
  3. * Below or above-knee amputation, critical limb ischemia (ulceration or gangrene)
  4. * Leg pain at rest
  5. * Cardiorespiratory disease
  6. * Diabetes
  7. * Major surgery or lower extremity revascularization during the previous 3 months
  8. * Major medical illness treatment during the prior 12 months
  9. * Central neurological disease
  10. * Limited ankle or knee joint range of motion
  11. * Requirement of oxygen with activity or exercise
  12. * More than a class II New York Heart Association level of heart failure
  13. * Wheelchair confinement, or inability to walk
  14. * Cognitive disorder
  15. * Vasculitis problem including Takayasu's arteritis, Buerger's disease, collagen disease or Raynaud's disease

Contacts and Locations

Principal Investigator

Judy Delp, PhD
PRINCIPAL_INVESTIGATOR
Florida State University, College of Medicine
Emily Pritchard, PhD
PRINCIPAL_INVESTIGATOR
Florida State University, College of Medicine

Study Locations (Sites)

Mayo Clinic Florida
Jacksonville, Florida, 32224
United States

Collaborators and Investigators

Sponsor: Florida State University

  • Judy Delp, PhD, PRINCIPAL_INVESTIGATOR, Florida State University, College of Medicine
  • Emily Pritchard, PhD, PRINCIPAL_INVESTIGATOR, Florida State University, College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-29
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2020-07-29
Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Peripheral Artery Disease