Mobile Intervention Supervised Exercise Therapy Study 1

NCT04832308 | Withdrawn

• 1 other identifier: 61023
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized controlled trial evaluating the impact of the mobile phone delivered SVS SET Program on utilization, functional capacity, symptoms and quality of life.

Conditions

Peripheral Artery Disease; Claudication, Intermittent

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Complete a 12-week Exercise Therapy Program

  Completion of a 12-week program in the treatment group will be completion of the remote SVS SET Program while the "usual care" group may have an in-person 12-week exercise therapy program.

  12 weeks.

Secondary Outcomes (5)

• Mobile Phone Delivered 6-Minute Walk Test

  Weeks 0, 6 and 12

• Passive Activity as Measured on Mobile Device

  12 weeks.

• Quality of Life Survey as measured by the mini-Walking Impairment Questionnaire (mini-WIQ)

  Weeks 1, 6, and 12

• Adherence as Measured by Completion of Scheduled Daily Walks

  12 weeks.

• Freedom From Intervention as Measured by Absence of Surgical Intervention at One Year

  1 year.

Study Arms (2)

SVS SET Program

EXPERIMENTAL

Participants enroll in SVS Program which includes 1) educational information on PAD, exercise and nutrition, 2) weekly health coaching, and 3) walking therapy prescription.

Behavioral: Exercise Therapy

Usual Care

NO INTERVENTION

This usual care arm will allow sites to direct patients as they usually do. This could include an in-person exercise therapy program or simply exercise instruction during an office visit.

Interventions

Exercise Therapy BEHAVIORAL

This is a health coach driven exercise prescription for patients recommending 30 minutes or more of moderate effort walking 3-5 days a week with expected walk-rest-walk-rest intervals.

SVS SET Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of Age
• Rutherford Class I-II PAD (claudication)
• Ambulatory
• Exercise Therapy Naive (\>18 mo)
• Primary Owner of an Android or iOS device
• Willingness to participate (text, call, fill out surveys) via a mobile phone

You may not qualify if:

• Symptomatic coronary artery disease
• Oxygen dependent COPD
• Significant osteoarthritis limiting ambulation

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• Society for Vascular Surgery: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Surgery

Model Details: Block randomization stratified by site.

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: August 20, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share