Recruiting

Telehealth Walking

Sponsor:

VA Office of Research and Development

Code:

NCT06033924

Conditions

Peripheral Artery Disease

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Walking Program: Internet-based

Walking Program: Telehealth-based

Study Details

Brief summary:

Walking is beneficial for adults with peripheral arterial disease. Benefits include the ability to walk for longer periods and general well being (quality of life). This study will look at two types of delivery methods for a home-based walking program. The walking program includes step count goals, information on healthy walking and motivational messages. The two delivery methods include a web-based delivery and an telehealth delivery. Participants are randomized to either one of the delivery methods or usual care. After 12 weeks participants in the web based or telehealth based groups maybe re-randomized to receive a combination of both web-based and telehealth for a second 12 week period. After 24 weeks, everyone is followed for an additional 12 weeks, so the total time a participant is in the study is 36 weeks. At baseline, 12, 24 and 36 weeks the investigators ask participant to walk (slowly) on a treadmill, perform a six-minute walk test, and several questionnaires on quality of life. Vouchers are provided at each study visit. All participants who complete the study also keep their pedometer.

Conditions

Peripheral Artery Disease

Study ID

NCT06033924

Start date

Jul 1, 2024

Status verified date

Apr, 2026

Completion date

Oct 29, 2027

Anticipated

Primary completion date

Oct 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men and women
  • Diagnosis of lower extremity PAD due to atherosclerosis
  • Claudication with walking defined as stage 1-3 on the Rutherford Scale
  • Medical clearance from the patient's primary care provider or vascular care provider
  • Ability to walk at least one city block
  • Self-reported sedentary behaviors defined as < 150 minutes per week of physical activity
  • Access to a phone and/or email \& Internet
  • Competent to provide informed consent

Exclusion Criteria:

  • Life expectancy of less than six months
  • Comorbidities that limit walking to a severe degree (i.e., wheelchair-bound)
  • Resident of a nursing home
  • Recent enrollment in an exercise program or performing 150 minutes per week or more of exercise
  • Planned revascularization or amputation in the next two months
  • Recent CVD events (< 3 months) including stroke/TIA, MI, UA, PCI/CABG
  • Unstable cardiac conditions (severe valve disease, NYHA class III-IV heart failure, untreated complex congenital heart disease, or complex arrhythmias)
  • Current substance abuse
  • Psychiatric disorder which limits the patient's ability to follow the study protocol
  • Pregnancy
  • Inability to speak and read English

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Internet-based Walking Program

Internet pages allow participants to see step-count goals, progress over time and access to walking tips

experimental: Telehealth Counseling Walking Program

Telehealth sessions allow participants review step-count goals, progress over time and access to walking tips with the study coordinator

Interventions

Walking Program: Internet-based

Internet pages allow participants to see step-count goals, progress over time and access to walking tips for 12 weeks. Among participants who do not increase their step counts (>15%), these non-responders will be rerandomized to received the combination of internet and telehealth or either along for an additional 12-weeks (total intervention time is 24-weeks). A follow-up phase of 12-weeks will be completed for a total participant duration of 36 weeks.

Walking Program: Telehealth-based

Telehealth sessions allow participants review step-count goals, progress over time and access to walking tips with the study coordinator for 12 weeks. Among participants who do not increase their step counts (>15%), these non-responders will be rerandomized to received the combination of internet and telehealth or either along for an additional 12-weeks (total intervention time is 24-weeks). A follow-up phase of 12-weeks will be completed for a total participant duration of 36 weeks.

Primary outcome measure

  • Change in maximal walking distance [ Time Frame: baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Elizabeth A Jackson, MD

(205) 933-8101elizabeth.jackson2@va.gov

Megan A Baker, BS

(205) 240-6552megan.baker6@va.gov

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Recruiting

Palo Alto, California, United States, 94304-1207

Contacts

Jonathan N Myers, PhD

123-456-7890jonathan.myers@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • peripheral artery disease
  • physical activity
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-06.