Results of a Study Based on a Telerehabilitation Program in Patients With Peripheral Arterial Disease of the Lower Limbs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Weeks exceeding an average of 10,000 steps per day
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Telerehabilitation
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.
干预措施: Home-based telerehabilitation (Behavioral)
结局指标
主要结局
Weeks exceeding an average of 10,000 steps per day
时间窗: Throughout the 6-month intervention period
Percentage of weeks in which the participant exceeded an average of 10,000 steps per day.
Achievement of the prescribed average daily step target
时间窗: 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
时间窗: 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
时间窗: Throughout the 6-month intervention period
Percentage of weeks in which the participant exceeded an average of 5,000 steps per day.
Median average daily step count during each 12-week period
时间窗: Throughout the 6-month intervention period
Median average daily step count during each 12-week period of the intervention.
次要结局
- Maximum exercise workload(Baseline, 3 months, and 6 months)
- Diastolic blood pressure(Baseline, 3 months, and 6 months)
- LDL cholesterol(Baseline, 3 months, and 6 months)
- Distance to onset of intermittent claudication(Baseline, 3 months, and 6 months)
- 6-Minute Walk Test distance(Baseline, 3 months, and 6 months)
- Percentage of predicted 6-Minute Walk Test distance(Baseline, 3 months, and 6 months)
- Heart rate during cardiopulmonary exercise testing(Baseline, 3 months, and 6 months)
- Oxygen consumption (VO2)(Baseline, 3 months, and 6 months)
- VE/VCO2 ratio(Baseline, 3 months, and 6 months)
- PADQOL score(Baseline, 3 months, and 6 months)
- QOLPAD score(Baseline, 3 months, and 6 months)
- VascuQoL-6 score(Baseline, 3 months, and 6 months)
- Systolic blood pressure(Baseline, 3 months, and 6 months)
- Ankle-brachial index(Baseline, 3 months, and 6 months)
- Body mass index(Baseline, 3 months, and 6 months)
- Fasting glucose(Baseline, 3 months, and 6 months)
- Glycated hemoglobin (HbA1c)(Baseline, 3 months, and 6 months)
- Total cholesterol(Baseline, 3 months, and 6 months)
- HDL cholesterol(Baseline, 3 months, and 6 months)
- Triglycerides(Baseline, 3 months, and 6 months)
研究者
Andreea Rotundu
Assistant Professor
Grigore T. Popa University of Medicine and Pharmacy