Telerehabilitation in Patients With Peripheral Arterial Disease

NCT07825168 | Completed

• 1 other identifier: GTP-TR-PAD-2023
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective longitudinal study evaluated the feasibility, adherence, and clinical and functional effects of a 6-month home-based telerehabilitation program in patients with peripheral arterial disease of the lower limbs. The program consisted of walking-based physical activity monitored using a smartwatch and weekly telephone counselling. Patients were encouraged to progressively increase their daily physical activity, with assessments performed at baseline, 3 months, and 6 months.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; telerehabilitation; home walking program; digital health; exercise adherence; wearable tracking

Outcome Measures

Primary Outcomes (5)

• Achievement of the prescribed average daily step target

  Percentage of weeks in which the participant achieved the average daily step target established for the following week.

  Throughout the 6-month intervention period

• Increase in average daily step count

  Percentage of weeks in which average daily steps increased compared with the previous week.

  Throughout the 6-month intervention period

• Weeks exceeding an average of 5,000 steps per day

  Percentage of weeks in which the participant exceeded an average of 5,000 steps per day.

  Throughout the 6-month intervention period

• Weeks exceeding an average of 10,000 steps per day

  Percentage of weeks in which the participant exceeded an average of 10,000 steps per day.

  Throughout the 6-month intervention period

• Median average daily step count during each 12-week period

  Median average daily step count during each 12-week period of the intervention.

  Throughout the 6-month intervention period

Secondary Outcomes (20)

• Distance to onset of intermittent claudication

  Baseline, 3 months, and 6 months

• 6-Minute Walk Test distance

  Baseline, 3 months, and 6 months

• Percentage of predicted 6-Minute Walk Test distance

  Baseline, 3 months, and 6 months

• Heart rate during cardiopulmonary exercise testing

  Baseline, 3 months, and 6 months

• Maximum exercise workload

  Baseline, 3 months, and 6 months

Study Arms (1)

Telerehabilitation

EXPERIMENTAL

Participants received a 6-month home-based telerehabilitation program consisting of walking-based physical activity monitored using a Xiaomi Smart Band 8 and supported by weekly telephone counselling. Participants were encouraged to progressively increase their daily step count according to individualized targets.

Behavioral: Home-based telerehabilitation

Interventions

Home-based telerehabilitation BEHAVIORAL

A 6-month home-based walking program supported by smartwatch-based monitoring of daily step counts and weekly telephone counselling. During weekly telephone contacts, the investigator reviewed the participant's activity during the preceding 7 days, assessed adherence, and provided individualized guidance and encouragement to continue and progressively increase walking activity.

Telerehabilitation

Eligibility Criteria

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

You may qualify if:

• age ≥18 years;
• diagnosis of PAD, defined by an ankle-brachial index (ABI) ≤0.90, arterial stenosis \>70% documented by angiography, or previous lower-extremity revascularization;
• ability to safely perform walking exercise at home;
• ability to use the activity-monitoring device and read the number of daily steps displayed on the device;
• access to and ability to use a mobile phone for telephone counseling;
• ability to complete the activity journal;
• provision of written informed consent.

You may not qualify if:

• chronic limb-threatening ischemia (CLTI);
• locomotor disability preventing participation in the walking exercise program;
• significant visual or hearing impairment interfering with participation in the in-tervention;
• moderate-to-severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \<17 \[17\];
• requirement for long-term oxygen therapy;
• incomplete medical records;
• inability to provide reliable information required for study assessments.

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead

Study Sites (1)

Spitalul Clinic de Recuperare Iași

Iași, Iaşi, 700686, Romania

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: January 3, 2023
• Primary Completion: June 5, 2024
• Study Completion: January 6, 2025
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)