Clinical trial NCT03458754: Maximal Exercise Capacity, Physical Activity and Respiratory Muscle Strength in Peripheral Artery Disease
Official title: Assessment of Exercise Capacity, Physical Activity, Pulmonary Function, Peripheric and Respiratory Muscle Strength, Respiratory Muscle Endurance in Patient With Peripheral Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Exercise capacity
Physical activity
Respiratory muscle strength
Peripheric muscle strength
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 15 patients with PAD will be included in patients group and 15 healthy individuals will be included in control group

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)

Eligibility criteria: 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

Primary outcomes:
measure: Maximal exercise capacity
timeFrame: First day
Secondary outcomes:
measure: Functional exercise capacity
timeFrame: Second day
measure: Physical activity
timeFrame: Second day
measure: Pulmonary function
timeFrame: First day
measure: Respiratory muscle strength
timeFrame: First day
measure: Peripheral muscle strength
timeFrame: Second day
measure: Respiratory muscle endurance
timeFrame: Second day
measure: Depression
timeFrame: Second day
measure: Life quality
timeFrame: Second day
measure: Intermittent claudication
timeFrame: Second day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
city: Yenimahalle
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Study officials:
affiliation: Gazi University
name: İnci Hazal Ayas, MSc
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral Boşnak Güçlü, Assoc. Prof
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Burcu Camcıoğlu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Dilek Erer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Abdullah Özer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leeper NJ, Myers J, Zhou M, Nead KT, Syed A, Kojima Y, Caceres RD, Cooke JP. Exercise capacity is the strongest predictor of mortality in patients with peripheral arterial disease. J Vasc Surg. 2013 Mar;57(3):728-33. doi: 10.1016/j.jvs.2012.07.051. Epub 2012 Oct 6.
citation: Pande RL, Perlstein TS, Beckman JA, Creager MA. Secondary prevention and mortality in peripheral artery disease: National Health and Nutrition Examination Study, 1999 to 2004. Circulation. 2011 Jul 5;124(1):17-23. doi: 10.1161/CIRCULATIONAHA.110.003954. Epub 2011 Jun 20.
citation: Nordanstig J, Broeren M, Hensater M, Perlander A, Osterberg K, Jivegard L. Six-minute walk test closely correlates to "real-life" outdoor walking capacity and quality of life in patients with intermittent claudication. J Vasc Surg. 2014 Aug;60(2):404-9. doi: 10.1016/j.jvs.2014.03.003. Epub 2014 Mar 29.
citation: Colas-Ribas C, Signolet I, Henni S, Feuillloy M, Gagnadoux F, Abraham P. High prevalence of known and unknown pulmonary diseases in patients with claudication during exercise oximetry: A retrospective analysis. Medicine (Baltimore). 2016 Oct;95(40):e4888. doi: 10.1097/MD.0000000000004888.
citation: Sieminski DJ, Gardner AW. The relationship between free-living daily physical activity and the severity of peripheral arterial occlusive disease. Vasc Med. 1997 Nov;2(4):286-91. doi: 10.1177/1358863X9700200402.
citation: Gardner AW, Montgomery PS, Scott KJ, Blevins SM, Afaq A, Nael R. Association between daily ambulatory activity patterns and exercise performance in patients with intermittent claudication. J Vasc Surg. 2008 Nov;48(5):1238-44. doi: 10.1016/j.jvs.2008.06.062. Epub 2008 Sep 4.