Peripheral Arterial DiseasePAD_TRNCT07825168
Telerehabilitation in Patients With Peripheral Arterial Disease
A study testing Home-based telerehabilitation in people with Peripheral Arterial Disease, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Home-based telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteRomania
- Study dates
- 3 Jan 2023to 6 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Results of a Study Based on a Telerehabilitation Program in Patients With Peripheral Arterial Disease of the Lower Limbs
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.
Read the detailed description
This prospective, single-arm study evaluated the feasibility and implementation of a 6-month home-based telerehabilitation program in patients with peripheral arterial disease (PAD) of the lower limbs. The intervention consisted of an individually prescribed walking-based physical activity program performed at home, supported by wearable activity monitoring and weekly telephone counselling. Participants used a Xiaomi Smart Band 8 to monitor daily step counts and were encouraged to progressively increase their physical activity according to individualized weekly targets. During the weekly telephone contacts, the investigator reviewed the participant's activity during the preceding 7 days, assessed adherence and provided individualized encouragement and guidance regarding continuation and progression of the walking program.
Clinical, functional, laboratory, and health-related quality-of-life assessments were performed at baseline, 3 months, and 6 months. Functional evaluation included the 6-minute walk test, ankle-brachial index, and cardiopulmonary exercise testing. Laboratory assessments included selected cardiometabolic and inflammatory parameters. Disease-specific health-related quality of life was assessed using validated PAD-specific questionnaires.
The study was designed to evaluate the feasibility and adherence to a digitally supported home-based rehabilitation model and to explore longitudinal changes in physical activity, functional capacity, quality of life, and selected clinical and laboratory parameters during the 6-month intervention period. As the study used a single-arm design without a control group, longitudinal changes were considered exploratory and cannot be interpreted as causal effects of the intervention.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Home-based telerehabilitation
- Keywords
- Peripheral Arterial Disease, telerehabilitation, home walking program, digital health, exercise adherence, wearable tracking
- 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.
Home-based telerehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Home-based telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Throughout the 6-month intervention period
Secondary outcomes (20)
Distance to onset of intermittent claudication
Distance (meters) walked until the onset of intermittent claudication symptoms during the 6-minute walk test.
Measured: Baseline, 3 months, and 6 months
6-Minute Walk Test distance
Total distance (meters) walked during the 6-minute walk test.
Measured: Baseline, 3 months, and 6 months
Percentage of predicted 6-Minute Walk Test distance
Percentage of predicted 6-minute walk distance achieved during the test.
Measured: Baseline, 3 months, and 6 months
Heart rate during cardiopulmonary exercise testing
Heart rate (beats/minute) measured during cardiopulmonary exercise testing.
Measured: Baseline, 3 months, and 6 months
Maximum exercise workload
Maximum exercise workload (watts)achieved during cardiopulmonary exercise testing.
Measured: Baseline, 3 months, and 6 months
Oxygen consumption (VO2)
Oxygen consumption (mL/kg/min) measured during cardiopulmonary exercise testing.
Measured: Baseline, 3 months, and 6 months
VE/VCO2 ratio
Minute ventilation to carbon dioxide production ratio during cardiopulmonary exercise testing.
Measured: Baseline, 3 months, and 6 months
PADQOL score
Health-related quality of life assessed using the PADQOL questionnaire (points).
Measured: Baseline, 3 months, and 6 months
QOLPAD score
Health-related quality of life assessed using the QOLPAD questionnaire (points).
Measured: Baseline, 3 months, and 6 months
VascuQoL-6 score
Health-related quality of life assessed using the VascuQoL-6 questionnaire (points).
Measured: Baseline, 3 months, and 6 months
Systolic blood pressure
Systolic blood pressure (mmHg) measured during clinical assessment.
Measured: Baseline, 3 months, and 6 months
Diastolic blood pressure
Diastolic blood pressure (mmHg)measured during clinical assessment.
Measured: Baseline, 3 months, and 6 months
Ankle-brachial index
Ankle-brachial index calculated as the ratio of ankle to brachial systolic blood pressure.
Measured: Baseline, 3 months, and 6 months
Body mass index
Body mass index (kg/m²)calculated from body weight and height.
Measured: Baseline, 3 months, and 6 months
Fasting glucose
Fasting blood glucose concentration (mg/dL).
Measured: Baseline, 3 months, and 6 months
Glycated hemoglobin (HbA1c)
Glycated hemoglobin(%) measured during laboratory assessment.
Measured: Baseline, 3 months, and 6 months
Total cholesterol
Serum total cholesterol concentration (mg/dL).
Measured: Baseline, 3 months, and 6 months
HDL cholesterol
Serum high-density lipoprotein cholesterol concentration (mg/dL).
Measured: Baseline, 3 months, and 6 months
LDL cholesterol
Serum low-density lipoprotein cholesterol concentration (mg/dL).
Measured: Baseline, 3 months, and 6 months
Triglycerides
Serum triglyceride concentration (mg/dL).
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start3 Jan 2023
- Primary completion5 Jun 2024
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreea Rotundu, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825168
- Sponsor's protocol ID
- GTP-TR-PAD-2023
- Acronym
- PAD_TR
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be shared with other researchers outside the study team. Study results will be reported in aggregate and published in a scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of a Study Based on a Telerehabilitation Program in Patients With Peripheral Arterial Disease of the Lower Limbs
- ClinicalTrials.gov ID
- NCT07825168
- Acronym / sponsor ID
- PAD_TR / GTP-TR-PAD-2023
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, telerehabilitation, home walking program, digital health, exercise adherence, wearable tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 17 Sep 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.
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.
Detailed description
This prospective, single-arm study evaluated the feasibility and implementation of a 6-month home-based telerehabilitation program in patients with peripheral arterial disease (PAD) of the lower limbs. The intervention consisted of an individually prescribed walking-based physical activity program performed at home, supported by wearable activity monitoring and weekly telephone counselling. Participants used a Xiaomi Smart Band 8 to monitor daily step counts and were encouraged to progressively increase their physical activity according to individualized weekly targets. During the weekly telephone contacts, the investigator reviewed the participant's activity during the preceding 7 days, assessed adherence and provided individualized encouragement and guidance regarding continuation and progression of the walking program.
Clinical, functional, laboratory, and health-related quality-of-life assessments were performed at baseline, 3 months, and 6 months. Functional evaluation included the 6-minute walk test, ankle-brachial index, and cardiopulmonary exercise testing. Laboratory assessments included selected cardiometabolic and inflammatory parameters. Disease-specific health-related quality of life was assessed using validated PAD-specific questionnaires.
The study was designed to evaluate the feasibility and adherence to a digitally supported home-based rehabilitation model and to explore longitudinal changes in physical activity, functional capacity, quality of life, and selected clinical and laboratory parameters during the 6-month intervention period. As the study used a single-arm design without a control group, longitudinal changes were considered exploratory and cannot be interpreted as causal effects of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Behavioral: Home-based telerehabilitationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based telerehabilitationA 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. | Behavioural | Telerehabilitation |
Primary outcome
Achievement of the prescribed average daily step target
Time frame: Throughout the 6-month intervention period
Percentage of weeks in which the participant achieved the average daily step target established for the following week.
Increase in average daily step count
Time frame: Throughout the 6-month intervention period
Percentage of weeks in which average daily steps increased compared with the previous week.
Weeks exceeding an average of 5,000 steps per day
Time frame: Throughout the 6-month intervention period
Percentage of weeks in which the participant exceeded an average of 5,000 steps per day.
Weeks exceeding an average of 10,000 steps per day
Time frame: Throughout the 6-month intervention period
Percentage of weeks in which the participant exceeded an average of 10,000 steps per day.
Median average daily step count during each 12-week period
Time frame: Throughout the 6-month intervention period
Median average daily step count during each 12-week period of the intervention.
20 secondary outcomes
Distance to onset of intermittent claudication
Time frame: Baseline, 3 months, and 6 months
6-Minute Walk Test distance
Time frame: Baseline, 3 months, and 6 months
Percentage of predicted 6-Minute Walk Test distance
Time frame: Baseline, 3 months, and 6 months
Heart rate during cardiopulmonary exercise testing
Time frame: Baseline, 3 months, and 6 months
Maximum exercise workload
Time frame: Baseline, 3 months, and 6 months
Oxygen consumption (VO2)
Time frame: Baseline, 3 months, and 6 months
VE/VCO2 ratio
Time frame: Baseline, 3 months, and 6 months
PADQOL score
Time frame: Baseline, 3 months, and 6 months
QOLPAD score
Time frame: Baseline, 3 months, and 6 months
VascuQoL-6 score
Time frame: Baseline, 3 months, and 6 months
Systolic blood pressure
Time frame: Baseline, 3 months, and 6 months
Diastolic blood pressure
Time frame: Baseline, 3 months, and 6 months
Ankle-brachial index
Time frame: Baseline, 3 months, and 6 months
Body mass index
Time frame: Baseline, 3 months, and 6 months
Fasting glucose
Time frame: Baseline, 3 months, and 6 months
Glycated hemoglobin (HbA1c)
Time frame: Baseline, 3 months, and 6 months
Total cholesterol
Time frame: Baseline, 3 months, and 6 months
HDL cholesterol
Time frame: Baseline, 3 months, and 6 months
LDL cholesterol
Time frame: Baseline, 3 months, and 6 months
Triglycerides
Time frame: Baseline, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be shared with other researchers outside the study team. Study results will be reported in aggregate and published in a scientific journal.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based telerehabilitation in people with Peripheral Arterial Disease, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 17 Sep 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 Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of the prescribed average daily step target (time frame: Throughout the 6-month intervention period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.