Smartstep Smartphone PAD

Not Applicable

Recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Behavioral: Standard exercise therapy; Behavioral: Smartphone-enabled structured exercise therapy (SE-SET)

• Registration Number: NCT03479255
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-03-27
• Study Start: 2018-08-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-06
• Primary Completion: 2024-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard exercise therapy	Standard exercise therapy	Self-directed, unsupervised exercise as prescribed by the patient's physician.
Smartphone-enabled structured exercise therapy (SE-SET)	Smartphone-enabled structured exercise therapy (SE-SET)	This arm involves a smartphone app Movn - rehabilitation platform based on MULTIFIT, a case-management system for secondary prevention and patient surveillance after acute MI. The key features of the smartphone app include daily reminders to exercise, virtual diary for patients to enter data on exercise sessions, two-way secure messaging with the health coach, and educational videos on heart and vascular health.

Primary Outcome Measures

Name	Time	Method
Change in 6-minute walk test (6MWT) distance completed	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 Outcome Measures

Name	Time	Method
Exercise-Related Injury	Over the 12-week study period	Number of Exercise-Related Injury events reported by participants
Change in claudication onset time during 6MWT	Immediately before and after the 12-week period	One typical symptom of peripheral arterial occlusive disease' (PAOD) is claudication , which is defined as pain, cramps, numbness or a sense of fatigue in the muscles associated with walking, in one or both lower limbs, affecting either the distal or proximal muscle groups.
Change in Physical Health Composite Score of SF-36	Immediately before and after the 12-week period	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to use special software. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.
Change in ankle-brachial pressure index (ABPI)	Immediately before and after the 12-week period	The ankle-brachial pressure index (ABPI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). Compared to the arm, lower blood pressure in the leg suggests blocked arteries due to peripheral artery disease (PAD). The ABPI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm.
Mortality	Over the 12-week study period	Number of deaths
Change in Walking Impairment Questionnaire (WIQ) score	Immediately before and after the 12-week period	WIQ measures self-reported walking distance, speed, and stair-climbing ability. In the WIQ distance score, the participant is asked to assess the degree of walking difficulty in walking specific distances on a scale from 0 to 4. A score of 0 represents the inability to walk the distance and a score of 4 represents no difficulty. WIQ speed score assesses the degree of difficulty in walking one block at specific speeds, ranging from walking slowly to jogging, on a scale of 0 to 4. In the WIQ stair-climbing score, the participant is asked to report the degree of difficulty climbing specific numbers of flights of stairs, ranging from one to three flights of stairs, on a scale of 0 to 4. This graded score is multiplied by a prespecified weight for each distance, speed, or number of stair flights. The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform any of the tasks) to 100 (representing no difficulty).
Change in number of steps/week	Immediately before and after the 12-week period	Number of steps/week will be obtained from participants' fitness trackers
Critical Limb Ischemia	Over the 12-week study period	Number of Critical Limb Ischemia events reported by participants
Other Cardiovascular Outcomes	Over the 12-week study period	Number of Cardiovascular Outcomes other than Critical Limb Ischemia events reported by participants

Trial Locations

Locations (1)

Grady Health System (non-CRN); 🇺🇸 Atlanta, Georgia, United States