Smartphone-Enabled Supervised Exercise Therapy for the Treatment of Symptomatic Peripheral Arterial Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Emory University
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Change in 6-minute walk test (6MWT) distance completed
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Amit J. Shah
Assistant Professor
Emory University
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:
- •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
Outcomes
Primary Outcomes
Change in 6-minute walk test (6MWT) distance completed
Time Frame: Immediately before and after the 12-week period
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Secondary Outcomes
- Change in claudication onset time during 6MWT(Immediately before and after the 12-week period)
- Change in Physical Health Composite Score of SF-36(Immediately before and after the 12-week period)
- Change in ankle-brachial pressure index (ABPI)(Immediately before and after the 12-week period)
- Mortality(Over the 12-week study period)
- Change in Walking Impairment Questionnaire (WIQ) score(Immediately before and after the 12-week period)
- Change in number of steps/week(Immediately before and after the 12-week period)
- Exercise-Related Injury(Over the 12-week study period)
- Critical Limb Ischemia(Over the 12-week study period)
- Other Cardiovascular Outcomes(Over the 12-week study period)