NCT07497360

Brief Summary

Peripheral artery disease (PAD) is a chronic and progressive condition caused by narrowing or blockage of arteries in the lower limbs due to atherosclerosis. It primarily affects adults over 50, with prevalence increasing with age, and its clinical presentation ranges from asymptomatic cases to severe ischemia that may require amputation. Intermittent claudication, characterized by exercise-induced leg pain that resolves with rest, is the most common early symptom. Impaired blood flow, poor vascularization, and muscle loss contribute to reduced lower limb strength and functional capacity, which are associated with higher morbidity and mortality. Walking exercises is a cornerstone of PAD management, particularly for patients with no or mild symptoms, making the assessment of lower limb strength and mobility essential for designing rehabilitation programs. The 30-second sit-to-stand test is a validated and practical measure of functional capacity and walking ability. Tele-assessment using video technology has been shown to be feasible and reliable in other patient populations. Although tele-rehabilitation has been widely studied and shown to improve functional outcomes, research on tele-assessment methods to accurately evaluate patient performance and the effectiveness of rehabilitation programs is still limited, particularly in PAD patients. This study aims to examine the reliability of the 30-second sit-to-stand test when performed via tele-assessment compared with face-to-face evaluation in patients with PAD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2026Jul 2026

Study Start

First participant enrolled

February 10, 2026

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 9, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

peripheral arterial diseasetelemedicineRemote ConsultationPhysical Functional Performance

Outcome Measures

Primary Outcomes (1)

  • Lower Extremity Function

    Lower extremity strength and functional mobility will be evaluated using the 30-second sit-to-stand test. Participants will sit on a 44 cm high chair with a backrest and no armrests, arms crossed over the shoulders, and will be instructed to stand and sit as many times as possible within 30 seconds. The number of complete repetitions will be recorded.

    From February 2026 to June 2026

Secondary Outcomes (5)

  • Perceived Fatigue Response to 30 Second Sit-to-Stand Test

    February 2026 to June 2026

  • Dyspnea Response to 30 Second Sit-to-Stand Test

    February 2026 to June 2026

  • Heart Rate Response to 30 Second Sit-to-Stand Test

    February 2026 to June 2026

  • Blood Pressure

    February 2026 to June 2026

  • Oxygen Saturation

    February 2026 to June 2026

Study Arms (1)

Peripheral Arterial Disease

This cohort includes adult patients diagnosed with peripheral artery disease. Participants will undergo a single assessment of lower extremity function using the 30-second sit-to-stand test, performed both face-to-face and via tele-assessment.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with peripheral artery disease, aged 18 to 65 years.

You may qualify if:

  • Aged between 18 and 65 years
  • Diagnosed with peripheral artery disease, Fontaine stage I-II, confirmed by peripheral angiography or Doppler ultrasonography
  • Willingness to participate in the study
  • Access to a smartphone and the internet

You may not qualify if:

  • Presence of orthopedic, neurological, or psychological conditions that limit physical activity
  • Neurological or musculoskeletal disorders affecting standing or walking
  • History of ischemic amputation
  • Acute inflammatory condition
  • Use of walking aids
  • Visual or hearing impairment
  • Vestibular system disorder
  • Cognitive impairment affecting cooperation
  • Severe cardiopulmonary diseases limiting walking ability
  • Major surgery or myocardial infarction within the last three months
  • Unstable coronary artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University Faculty of Medicine

Izmir, Balçova, 35330, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Zischke C, Simas V, Hing W, Milne N, Spittle A, Pope R. The utility of physiotherapy assessments delivered by telehealth: A systematic review. J Glob Health. 2021 Dec 18;11:04072. doi: 10.7189/jogh.11.04072. eCollection 2021.

    PMID: 34956637BACKGROUND
  • Bowman A, Denehy L, Benjemaa A, Crowe J, Bruns E, Hall T, Traill A, Edbrooke L. Feasibility and safety of the 30-second sit-to-stand test delivered via telehealth: An observational study. PM R. 2023 Jan;15(1):31-40. doi: 10.1002/pmrj.12783. Epub 2022 Mar 22.

    PMID: 35138036BACKGROUND
  • Aktan R, Yilmaz H, Demir I, Ozalevli S. Agreement between tele-assessment and face-to-face assessment of 30-s sit-to-stand test in patients with type 2 diabetes mellitus. Ir J Med Sci. 2023 Oct;192(5):2173-2178. doi: 10.1007/s11845-022-03238-w. Epub 2022 Dec 2.

    PMID: 36456718BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Central Study Contacts

Hazal Yakut Ozdemir, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 27, 2026

Study Start

February 10, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to privacy concerns.

Locations