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).
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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University Faculty of Medicine
Izmir, Balçova, 35330
Kıvanç Metin, PhD, +9005322966938, kivanc.metin@deu.edu.tr
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).
- Conditions
- Peripheral Arterial Disease
- 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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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.
- First posted27 Mar 2026
- Study start10 Feb 2026
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Taşpınar, Izmir Democracy University
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 34956637Bowman 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 35138036Aktan 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07497360
- Acronym / sponsor ID
- 2025/43-08
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral arterial disease, telemedicine, Remote Consultation, Physical Functional Performance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with peripheral artery disease, aged 18 to 65 years.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lower Extremity Function
Time frame: From February 2026 to June 2026
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.
5 secondary outcomes
Perceived Fatigue Response to 30 Second Sit-to-Stand Test
Time frame: February 2026 to June 2026
Dyspnea Response to 30 Second Sit-to-Stand Test
Time frame: February 2026 to June 2026
Heart Rate Response to 30 Second Sit-to-Stand Test
Time frame: February 2026 to June 2026
Blood Pressure
Time frame: February 2026 to June 2026
Oxygen Saturation
Time frame: February 2026 to June 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 34956637Zischke 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.
- Background: PubMed 35138036Bowman 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.
- Background: PubMed 36456718Aktan 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns.
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.