Clinical trial NCT03479255: Smartstep Smartphone PAD
Official title: Smartphone-Enabled Supervised Exercise Therapy for the Treatment of Symptomatic Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Smartphone
Exercise
Functional capacity
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Woodruff Health Sciences Center Foundation
First posted: 2018-03-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective clinical trial that will randomize patients in 1:1 ratio to smartphone-enabled structured exercise therapy (SE-SET) vs. standard exercise therapy (usual care)
Primary purpose: TREATMENT

Brief summary: The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).

Detailed description: Structured exercise therapy is a first line treatment for symptomatic peripheral artery disease, but compliance is poor. Coaching programs may help but requires significant resources. Smartphone programs may increase the efficiency of such efforts. The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care) in patients at Grady Memorial Hospital's vascular clinic.

Eligibility criteria: Inclusion Criteria:

* Clinically stable intermittent claudication
* Able to give informed consent
* Age 18-89 years

And one of the following:

* ABI \< 0.9 after 10 minutes of rest OR
* For subjects with an ABI of \>1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of \< 0.70 must be obtained for subject qualification. If ABI is \> 0.9 to 1.0, a reduction of 20% in ABI must be measured within 1 minute of treadmill testing.

Exclusion Criteria:

Life-threatening process including:

* Sepsis
* Critical limb ischemia (Rutherford class 4-6)
* Unstable angina
* Active malignancy with life expectancy \< 6 months
* Severe NYHA Class IV heart failure

Condition other than PAD that limits walking before claudication onset

This includes, but is not limited to:

* Severe angina or dyspnea
* Arthritis
* Muscle weakness/pain

Active behavioral conditions such as uncontrolled schizophrenia or illicit drug addiction that, in the opinion of the study team, will interfere with active participation

Inability to attend study visits

Primary outcomes:
measure: Change in 6-minute walk test (6MWT) distance completed
timeFrame: Immediately before and after the 12-week period
Secondary outcomes:
measure: Change in Walking Impairment Questionnaire (WIQ) score
timeFrame: Immediately before and after the 12-week period
measure: Change in Physical Health Composite Score of SF-36
timeFrame: Immediately before and after the 12-week period
measure: Change in claudication onset time during 6MWT
timeFrame: Immediately before and after the 12-week period
measure: Change in ankle-brachial pressure index (ABPI)
timeFrame: Immediately before and after the 12-week period
measure: Change in number of steps/week
timeFrame: Immediately before and after the 12-week period
measure: Critical Limb Ischemia
timeFrame: Over the 12-week study period
measure: Other Cardiovascular Outcomes
timeFrame: Over the 12-week study period
measure: Exercise-Related Injury
timeFrame: Over the 12-week study period
measure: Mortality
timeFrame: Over the 12-week study period
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System (non-CRN)
state: Georgia
Study officials:
affiliation: Emory University
name: Amit Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: