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Completed

NCT Number: NCT03458754

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University, Ankara, Turkey (Türkiye)

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About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Maximal exercise capacity

    Time frame: First day

    Cardiopulmonary exercise testing (Oxygen consumption measurement during test)

Secondary outcomes

  1. Functional exercise capacity

    Time frame: Second day

    Six minute stepper test

  2. Physical activity

    Time frame: Second day

    Multi sensor activity monitor

  3. Pulmonary function

    Time frame: First day

    Spirometry

  4. Respiratory muscle strength

    Time frame: First day

    Mouth pressure device

  5. Peripheral muscle strength

    Time frame: Second day

    Hand held dynamometer

  6. Respiratory muscle endurance

    Time frame: Second day

    Incremental threshold loading test

  7. Depression

    Time frame: Second day

    Beck depression inventory (Turkish version)

  8. Life quality

    Time frame: Second day

    SF-36 Health Survey (Turkish version)

  9. Intermittent claudication

    Time frame: Second day

    Walking Impairment Questionnaire (Turkish version)

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 8, 2018
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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