Clinical trial NCT04222751: Static Muscular Stretching for Treatment of PAD
Official title: Static Muscular Stretching for Treatment of Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2020-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age 40+
* A resting ankle-brachial index (ABI) of 0.90 or less in either leg
* Stable disease (PAD) for a minimum of 3-months

Exclusion Criteria:

* Habitual exercise (30 minutes of continuous activity for 3 or more days per week)
* Cardiovascular rehabilitation program during the past 3 months
* Below or above-knee amputation, critical limb ischemia (ulceration or gangrene)
* Leg pain at rest
* Cardiorespiratory disease
* Diabetes
* Major surgery or lower extremity revascularization during the previous 3 months
* Major medical illness treatment during the prior 12 months
* Central neurological disease
* Limited ankle or knee joint range of motion
* Requirement of oxygen with activity or exercise
* More than a class II New York Heart Association level of heart failure
* Wheelchair confinement, or inability to walk
* Cognitive disorder
* Vasculitis problem including Takayasu's arteritis, Buerger's disease, collagen disease or Raynaud's disease

Primary outcomes:
measure: Change in Muscle Oxygenation
timeFrame: 4 weeks
measure: Change in Continuous Walking Distance
timeFrame: 4 weeks
measure: Change in Total Walking Distance
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Florida State University, College of Medicine
name: Judy Delp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida State University, College of Medicine
name: Emily Pritchard, PhD
role: PRINCIPAL_INVESTIGATOR
References: