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Clinical Trials/NCT03458754
NCT03458754
Completed
N/A

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

Gazi University2 sites in 1 country35 target enrollmentJanuary 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
Gazi University
Enrollment
35
Locations
2
Primary Endpoint
Maximal exercise capacity
Status
Completed
Last Updated
5 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
March 31, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meral Boşnak Güçlü

Assoc. Prof

Gazi University

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Maximal exercise capacity

Time Frame: First day

Cardiopulmonary exercise testing (Oxygen consumption measurement during test)

Secondary Outcomes

  • Life quality(Second day)
  • Intermittent claudication(Second day)
  • Functional exercise capacity(Second day)
  • Pulmonary function(First day)
  • Respiratory muscle strength(First day)
  • Peripheral muscle strength(Second day)
  • Depression(Second day)
  • Physical activity(Second day)
  • Respiratory muscle endurance(Second day)

Study Sites (2)

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