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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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.
Spitalul Clinic de Recuperare Iași
Iași, Iaşi, Romania
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Throughout the 6-month intervention period
Distance to onset of intermittent claudication
Distance (meters) walked until the onset of intermittent claudication symptoms during the 6-minute walk test.
Time frame: Baseline, 3 months, and 6 months
6-Minute Walk Test distance
Total distance (meters) walked during the 6-minute walk test.
Time frame: Baseline, 3 months, and 6 months
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Percentage of predicted 6-Minute Walk Test distance
Percentage of predicted 6-minute walk distance achieved during the test.
Time frame: Baseline, 3 months, and 6 months
Heart rate during cardiopulmonary exercise testing
Heart rate (beats/minute) measured during cardiopulmonary exercise testing.
Time frame: Baseline, 3 months, and 6 months
Maximum exercise workload
Maximum exercise workload (watts)achieved during cardiopulmonary exercise testing.
Time frame: Baseline, 3 months, and 6 months
Oxygen consumption (VO2)
Oxygen consumption (mL/kg/min) measured during cardiopulmonary exercise testing.
Time frame: Baseline, 3 months, and 6 months
VE/VCO2 ratio
Minute ventilation to carbon dioxide production ratio during cardiopulmonary exercise testing.
Time frame: Baseline, 3 months, and 6 months
PADQOL score
Health-related quality of life assessed using the PADQOL questionnaire (points).
Time frame: Baseline, 3 months, and 6 months
QOLPAD score
Health-related quality of life assessed using the QOLPAD questionnaire (points).
Time frame: Baseline, 3 months, and 6 months
VascuQoL-6 score
Health-related quality of life assessed using the VascuQoL-6 questionnaire (points).
Time frame: Baseline, 3 months, and 6 months
Systolic blood pressure
Systolic blood pressure (mmHg) measured during clinical assessment.
Time frame: Baseline, 3 months, and 6 months
Diastolic blood pressure
Diastolic blood pressure (mmHg)measured during clinical assessment.
Time frame: Baseline, 3 months, and 6 months
Ankle-brachial index
Ankle-brachial index calculated as the ratio of ankle to brachial systolic blood pressure.
Time frame: Baseline, 3 months, and 6 months
Body mass index
Body mass index (kg/m²)calculated from body weight and height.
Time frame: Baseline, 3 months, and 6 months
Fasting glucose
Fasting blood glucose concentration (mg/dL).
Time frame: Baseline, 3 months, and 6 months
Glycated hemoglobin (HbA1c)
Glycated hemoglobin(%) measured during laboratory assessment.
Time frame: Baseline, 3 months, and 6 months
Total cholesterol
Serum total cholesterol concentration (mg/dL).
Time frame: Baseline, 3 months, and 6 months
HDL cholesterol
Serum high-density lipoprotein cholesterol concentration (mg/dL).
Time frame: Baseline, 3 months, and 6 months
LDL cholesterol
Serum low-density lipoprotein cholesterol concentration (mg/dL).
Time frame: Baseline, 3 months, and 6 months
Triglycerides
Serum triglyceride concentration (mg/dL).
Time frame: Baseline, 3 months, and 6 months