Peripheral artery disease Circulatory System
Conditions
Interventions
Eligible patients were randomized either to an arm-ergometry supervised exercise training or a treadmill walking exercise protocol. Randomization was performed with a computer-based random number gene
then the patient stopped and rested until the claudication pain completely resolved and then resumed walking.
Arm-ergometry protocol: The arm-ergometry exercise prescription followed the guidelines f
exercise intensity was determined using the cardiopulmonary exercise test results.
Additionally, all patients received nutritional and psychological intervention according to international guidelines
Sponsors
Centro Hospitalar Universitário de Santo António
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Patients with PAD older than 18 years old referred to the Cardiovascular Rehabilitation Unit 2. PAD was diagnosed through a clinical history and physical examination and confirmed by an ankle-brachial index (ABI) =0.90 and/or an ABI decrease =10% after a symptom-limited treadmill stress test 3. Patients able to walk at a speed of at least 3.2 Km/h 4. Able to participate in a supervised exercise program for 12 weeks 5. No change in medication for PAD (cilostazol, pentoxifylline, statin and antiplatelet therapy) at least 3 months prior to study enrollment. Medication remained unchanged during the study intervention period.
Exclusion criteria
Exclusion criteria: 1. PAD Leriche-Fontaine stages I, III or IV 2. A revascularization procedure during the previous 12 months 3. Other chronic conditions causing exercise impairment more than PAD 4. Acute cardiovascular event less than 3 months prior to enrollment 5. Clinical contraindications for physical exercise practice, according to current guidelines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiorespiratory fitness: Oxygen uptake (VO2) peak evaluated on a treadmill cardiopulmonary exercise test (CPET) at baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. VO2 at VT-1 (first ventilatory threshold) assessed by CPET at baseline and 12 weeks 2. Ventilatory efficiency: minute ventilation to carbon dioxide production slope (VE/VCO2 slope) assessed by CPET at baseline and 12 weeks 3. Maximal walking distance (MWD) evaluated on CPET at baseline and 12 weeks 4. Pain-free walking distance (PFWD) evaluated on CPET at baseline and 12 weeks 5. Maximal walking distance (MWD) assessed in a 6-minute walking test at baseline and 12 weeks 6. Pain-free walking distance (PFWD) assessed in CPET at baseline and 12 weeks 7. Self-reported walking limitations, evaluated in the Walking Impairment Questionnaire (WIQ), taking into account: distance (WIQd), speed (WIQs) and stair climbing (WIQ sc) scores; at baseline and 12 weeks 8. Walking economy: Submaximal V?O2 evaluated on CPET at baseline and 12 weeks 9. Health-related quality of life assessed through the Short form 36 health survey version 2 at baseline and 12 weeks 10. Anxiety and depression symptoms assessed using the Hospital Anxiety and Depression Scale at baseline and 12 weeks 11. Resting brachial systolic blood pressure and diastolic blood pressure measured by an automated measurement device at baseline and 12 weeks 12. Hyperlipidemia measured through fasting blood biochemistry including total cholesterol (TC-C), low-density lipoprotein (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) at baseline and 12 weeks 13. Diabetes control measured through glycated haemoglobin (%) in fasting state at baseline and 12 weeks 14. Body composition: body mass index (BMI) and waist circumference (WC) at baseline and 12 weeks 15. Self-reported physical activity assessed using the International Physical Activity Questionnaire, classifying the activity into three categories (low activity levels, moderate activity levels or high activity levels) at baseline and 12 weeks 16. Physical activity: patients utilized a wearable smartwatch to monitor their daily step count at base | — |
Countries
Portugal
Contacts
Public ContactSandra Magalhães
Outcome results
None listed