Maximal Exercise Capacity, Physical Activity and Respiratory Muscle Strength in Peripheral Artery Disease

Study Overview
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Brief Summary
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The primary aim of the study is to evaluate the maximal and submaximal exercise capacity in patients with peripheral artery disease (PAD). The secondary aim of the study is assessment of physical activity level, respiratory function, peripheral and respiratory muscle strength, respiratory muscle endurance, depression, quality of life, intermittent claudication and cardiovascular risk factors in patients with PAD.

Detailed Description
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Peripheral artery disease is characterized by reduced exercise capacity, physical activity level and intermittent claudication. The number of studies investigating maximal and submaximal exercise capacity and physical activity level in PAD is limited. There is also no study investigated pulmonary functions, respiratory muscle strength and endurance in this patient population. According to the sample size analysis 15 patients and 15 healthy individuals with similar demographic characteristics will be included the study. Patients and healthy individuals will be selected according to predetermined inclusion and exclusion criteria. The assessments will be completed in two days.Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version)

Official Title
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Assessment of Exercise Capacity, Physical Activity, Pulmonary Function, Peripheric and Respiratory Muscle Strength, Respiratory Muscle Endurance in Patient With Peripheral Artery Disease

Conditions
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Peripheral Arterial Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients; Diagnosed with peripheral artery disease Ankle brachial index (ABI)≤ 1,5 or calcified vessel response Clinically stable and under standard medication patients will be included Exclusion Criteria: Patients with; Ischemic amputation Any pulmonary disease Unstable coronary artery disease Orthopedic and neurological problems Acute infection Myocardial infarction or major surgery in the last 3 months will be excluded Healthy controls: Ages 18-80 years will be included With any diagnosed disease and smoking more than 10 packsyears will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version) | |
| Healthy controls<br>Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal exercise capacity | Cardiopulmonary exercise testing (Oxygen consumption measurement during test) | First day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional exercise capacity | Six minute stepper test | Second day | 
| Physical activity | Multi sensor activity monitor | Second day | 
| Pulmonary function | Spirometry | First day | 
| Respiratory muscle strength | Mouth pressure device | First day | 
| Peripheral muscle strength | Hand held dynamometer | Second day | 
| Respiratory muscle endurance | Incremental threshold loading test | Second day | 
| Depression | Beck depression inventory (Turkish version) | Second day | 
| Life quality | SF-36 Health Survey (Turkish version) | Second day | 
| Intermittent claudication | Walking Impairment Questionnaire (Turkish version) | Second day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Peripheral Arterial Disease, Exercise capacity, Respiratory muscle strength, Peripheric muscle strength