Peripheral Arterial Disease
Conditions
Keywords
Peripheral Arterial Disease, telerehabilitation, home walking program, digital health, exercise adherence, wearable tracking
Brief 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. 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.
Interventions
BEHAVIORALHome-based telerehabilitation
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.
Sponsors
Grigore T. Popa University of Medicine and Pharmacy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥18 years; 2. diagnosis of PAD, defined by an ankle-brachial index (ABI) ≤0.90, arterial stenosis \>70% documented by angiography, or previous lower-extremity revascularization; 3. ability to safely perform walking exercise at home; 4. ability to use the activity-monitoring device and read the number of daily steps displayed on the device; 5. access to and ability to use a mobile phone for telephone counseling; 6. ability to complete the activity journal; 7. provision of written informed consent.
Exclusion criteria
1. chronic limb-threatening ischemia (CLTI); 2. locomotor disability preventing participation in the walking exercise program; 3. significant visual or hearing impairment interfering with participation in the in-tervention; 4. moderate-to-severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \<17 \[17\]; 5. requirement for long-term oxygen therapy; 6. incomplete medical records; 7. inability to provide reliable information required for study assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of the prescribed average daily step target | 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 | 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 | 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 | 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 | Throughout the 6-month intervention period | Median average daily step count during each 12-week period of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distance to onset of intermittent claudication | Baseline, 3 months, and 6 months | Distance (meters) walked until the onset of intermittent claudication symptoms during the 6-minute walk test. |
| 6-Minute Walk Test distance | Baseline, 3 months, and 6 months | Total distance (meters) walked during the 6-minute walk test. |
| Percentage of predicted 6-Minute Walk Test distance | Baseline, 3 months, and 6 months | Percentage of predicted 6-minute walk distance achieved during the test. |
| Heart rate during cardiopulmonary exercise testing | Baseline, 3 months, and 6 months | Heart rate (beats/minute) measured during cardiopulmonary exercise testing. |
| Maximum exercise workload | Baseline, 3 months, and 6 months | Maximum exercise workload (watts)achieved during cardiopulmonary exercise testing. |
| Oxygen consumption (VO2) | Baseline, 3 months, and 6 months | Oxygen consumption (mL/kg/min) measured during cardiopulmonary exercise testing. |
| VE/VCO2 ratio | Baseline, 3 months, and 6 months | Minute ventilation to carbon dioxide production ratio during cardiopulmonary exercise testing. |
| PADQOL score | Baseline, 3 months, and 6 months | Health-related quality of life assessed using the PADQOL questionnaire (points). |
| QOLPAD score | Baseline, 3 months, and 6 months | Health-related quality of life assessed using the QOLPAD questionnaire (points). |
| VascuQoL-6 score | Baseline, 3 months, and 6 months | Health-related quality of life assessed using the VascuQoL-6 questionnaire (points). |
| Systolic blood pressure | Baseline, 3 months, and 6 months | Systolic blood pressure (mmHg) measured during clinical assessment. |
| Diastolic blood pressure | Baseline, 3 months, and 6 months | Diastolic blood pressure (mmHg)measured during clinical assessment. |
| Ankle-brachial index | Baseline, 3 months, and 6 months | Ankle-brachial index calculated as the ratio of ankle to brachial systolic blood pressure. |
| Body mass index | Baseline, 3 months, and 6 months | Body mass index (kg/m²)calculated from body weight and height. |
| Fasting glucose | Baseline, 3 months, and 6 months | Fasting blood glucose concentration (mg/dL). |
| Glycated hemoglobin (HbA1c) | Baseline, 3 months, and 6 months | Glycated hemoglobin(%) measured during laboratory assessment. |
| Total cholesterol | Baseline, 3 months, and 6 months | Serum total cholesterol concentration (mg/dL). |
| HDL cholesterol | Baseline, 3 months, and 6 months | Serum high-density lipoprotein cholesterol concentration (mg/dL). |
| LDL cholesterol | Baseline, 3 months, and 6 months | Serum low-density lipoprotein cholesterol concentration (mg/dL). |
| Triglycerides | Baseline, 3 months, and 6 months | Serum triglyceride concentration (mg/dL). |
Countries
Romania
Outcome results
None listed