Smartstep Smartphone PAD (SMARTSTEP)

  • STATUS
    Recruiting
  • End date
    Sep 26, 2023
  • participants needed
    50
  • sponsor
    Emory University
Updated on 5 March 2022
intermittent claudication
exercise therapy

Summary

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

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.

Details
Condition Peripheral Arterial Disease
Treatment Smartphone-enabled structured exercise therapy (SE-SET), Standard exercise therapy
Clinical Study IdentifierNCT03479255
SponsorEmory University
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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