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

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT03458754
• Lead Sponsor: Gazi University

Brief Summary

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

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)

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximal exercise capacity	First day	Cardiopulmonary exercise testing (Oxygen consumption measurement during test)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation; 🇹🇷 Yenimahalle, Turkey

Gazi University; 🇹🇷 Ankara, Turkey