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Peripheral Arterial DiseaseNCT07497360

Tele-assessment and Face-to-face Assessment of the 30-second Sit-stand Test in Peripheral Artery Disease

An observational study of Peripheral Arterial Disease, run by Izmir Democracy University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Peripheral Arterial Disease
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Feb 2026to Jul 2026
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hazal Yakut Ozdemir, PhD contact

+9005074825877

hazal.yakutozdemir@idu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Dokuz Eylul University Faculty of Medicine

    Izmir, Balçova, 35330

    Kıvanç Metin, PhD, +9005322966938, kivanc.metin@deu.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Consistency Between Tele-Assessment and Face-to-Face Assessment Results of the 30-Second Sit-to-Stand Test in Patients With Peripheral Arterial Disease

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.

Read the detailed description

Peripheral artery disease (PAD) is a progressive, chronic cardiovascular disorder characterized by narrowing and occlusion of the lower extremity arteries due to atherosclerosis. Peripheral artery disease (PAD) predominantly affects individuals over the age of 50, with its prevalence increasing progressively with age. The clinical presentation of PAD varies widely, from asymptomatic cases to severe ischemia that may necessitate amputation. Globally, PAD affects over 200 million individuals, while in Turkey, prevalence has been reported at 19.76%. Major risk factors include age, race, sex, smoking, diabetes, hypertension, dyslipidemia, and sedentary lifestyle.

Peripheral artery disease (PAD) commonly presents with intermittent claudication (IC), characterized by exercise-induced lower limb pain that resolves with rest. IC, resulting from reduced oxygen delivery to leg muscles due to arterial obstruction, manifests as pain, cramps, or numbness during activity and may progress to rest pain in advanced stages, affecting 10-35% of patients. Impaired circulation, decreased vascularization, and muscle atrophy contribute to reductions in lower extremity strength and functional capacity, which are associated with increased morbidity and mortality. The Fontaine classification system stages PAD severity from asymptomatic (Stage I) to critical limb ischemia with ulceration or gangrene (Stage IV).

Management strategies include lifestyle modification, exercise, pharmacological therapy, and surgical interventions, with exercise recognized as the most effective and cost-efficient approach for asymptomatic or mildly symptomatic patients. Assessing lower limb strength and mobility is essential for tailoring rehabilitation programs, as PAD patients show significant deficits in functional mobility and muscle strength compared to healthy individuals. The 30-second sit-to-stand test is a validated, practical measure of lower extremity function and is an independent predictor of walking capacity in PAD.

Tele-assessment methods, enabled by internet and smartphone technologies, offer remote evaluation of functional mobility using tests such as the 30-second sit-to-stand, timed up-and-go, and five-repetition sit-to-stand tests. Evidence suggests tele-assessment is reliable, feasible, and cost- and time-efficient, particularly for elderly or mobility-limited populations. However, its accuracy depends on technology quality and patient compliance. Despite studies in populations with type 2 diabetes, hip osteoarthritis, and cancer, the reliability and agreement of the 30-second sit-to-stand test via tele-assessment have not yet been evaluated in PAD patients. Investigating this could inform the development of tele-rehabilitation programs targeting lower extremity strength and functional mobility in PAD.

Therefore, this study aims to investigate the reliability of the 30-second sit-to-stand test between tele-assessment and face-to-face assessment in patients with peripheral artery disease (PAD).

Participants' lower extremity strength and functional mobility will be evaluated using the 30-second sit-to-stand test both face-to-face and online via WhatsApp on the same day. Face-to-face assessments will be conducted at the Department of Cardiovascular Surgery, Dokuz Eylül University Faculty of Medicine.

During tele-assessment, the physiotherapist and the patient will be at the Department of Cardiovascular Surgery; however, the physiotherapist will be in a separate room and will complete the evaluation synchronously via online video. Face-to-face and tele-assessments will be performed by two different physiotherapists participating in the study. The two assessments will be conducted 20-30 minutes apart, and to control for any potential test order effect, the sequence of assessments will be randomized for each participant and physiotherapist using a simple random number table.

During the face-to-face assessment, demographic and clinical information will be collected, including age, sex, body weight and height, body mass index, educational level, occupation, marital status, lifestyle habits (smoking, alcohol consumption, physical activity), medical history (past illnesses), and clinical data (year of PAD diagnosis, disease duration, medications, and comorbidities).

Keywords
peripheral arterial disease, telemedicine, Remote Consultation, Physical Functional Performance
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07497360
Study groupRoleWhat they receive
Peripheral Arterial DiseaseThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From February 2026 to June 2026

Secondary outcomes (5)
  1. Perceived Fatigue Response to 30 Second Sit-to-Stand Test

    Perceived fatigue will be measured before, immediately after, and at 3 minutes of recovery following the sit-to-stand test using the Modified Borg Scale.

    Measured: February 2026 to June 2026

  2. Dyspnea Response to 30 Second Sit-to-Stand Test

    Dyspnea severity will be assessed before, immediately after, and at 3 minutes of recovery following the sit-to-stand test using the Modified Borg Scale.

    Measured: February 2026 to June 2026

  3. Heart Rate Response to 30 Second Sit-to-Stand Test

    Heart rate will be measured before, immediately after, and at 3 minutes of recovery following the sit-to-stand test using a pulse oximeter.

    Measured: February 2026 to June 2026

  4. Blood Pressure

    Systolic and diastolic blood pressure will be measured before, immediately after, and at 3 minutes of recovery following the sit-to-stand test.

    Measured: February 2026 to June 2026

  5. Oxygen Saturation

    Peripheral oxygen saturation (SpO₂) will be measured before, immediately after, and at 3 minutes of recovery following the sit-to-stand test using a pulse oximeter.

    Measured: February 2026 to June 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start10 Feb 2026
  3. Primary completionJun 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
45 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07497360
Sponsor's protocol ID
2025/43-08
Status last verified
Mar 2026
First submitted
9 Mar 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to privacy concerns.

Publications

  • 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.

    PubMed 34956637
  • 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.

    PubMed 35138036
  • 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.

    PubMed 36456718

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease, run by Izmir Democracy University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hazal Yakut Ozdemir, PhD (+9005074825877, hazal.yakutozdemir@idu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lower Extremity Function (time frame: From February 2026 to June 2026). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07497360, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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