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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458754
• Other study ID #: Gazi University 9
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: November 2020
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara
Turkey	Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation	Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. — View Citation

Nordanstig J, Broeren M, Hensäter M, Perlander A, Osterberg K, Jivegård 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal exercise capacity	Cardiopulmonary exercise testing (Oxygen consumption measurement during test)	First day
Secondary	Functional exercise capacity	Six minute stepper test	Second day
Secondary	Physical activity	Multi sensor activity monitor	Second day
Secondary	Pulmonary function	Spirometry	First day
Secondary	Respiratory muscle strength	Mouth pressure device	First day
Secondary	Peripheral muscle strength	Hand held dynamometer	Second day
Secondary	Respiratory muscle endurance	Incremental threshold loading test	Second day
Secondary	Depression	Beck depression inventory (Turkish version)	Second day
Secondary	Life quality	SF-36 Health Survey (Turkish version)	Second day
Secondary	Intermittent claudication	Walking Impairment Questionnaire (Turkish version)	Second day