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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03458754
Enrollment
35
Registered
2018-03-08
Start date
2018-01-01
Completion date
2019-03-31
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease, Exercise capacity, Physical activity, Respiratory muscle strength, Peripheric muscle strength

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)

Interventions

None listed

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maximal exercise capacityFirst dayCardiopulmonary exercise testing (Oxygen consumption measurement during test)

Secondary

MeasureTime frameDescription
Physical activitySecond dayMulti sensor activity monitor
Pulmonary functionFirst daySpirometry
Respiratory muscle strengthFirst dayMouth pressure device
Peripheral muscle strengthSecond dayHand held dynamometer
Functional exercise capacitySecond daySix minute stepper test
DepressionSecond dayBeck depression inventory (Turkish version)
Life qualitySecond daySF-36 Health Survey (Turkish version)
Intermittent claudicationSecond dayWalking Impairment Questionnaire (Turkish version)
Respiratory muscle enduranceSecond dayIncremental threshold loading test

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026