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

NCT03458754 | Completed

• 1 other identifier: Gazi University 9
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Arterial Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximal exercise capacity

  Cardiopulmonary exercise testing (Oxygen consumption measurement during test)

  First day

Secondary Outcomes (9)

• Functional exercise capacity

  Second day

• Physical activity

  Second day

• Pulmonary function

  First day

• Respiratory muscle strength

  First day

• Peripheral muscle strength

  Second day

Study Arms (2)

Patients

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)

Healthy controls

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

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Gazi University

Ankara, 06500, Turkey (Türkiye)

Location

Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Yenimahalle, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 23044259 BACKGROUND

• 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.

  PMID: 21690489 BACKGROUND

• 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.

  PMID: 24690492 BACKGROUND

• 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.

  PMID: 27749546 BACKGROUND

• 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.

  PMID: 9575600 BACKGROUND

• 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.

  PMID: 18771878 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Study Officials

• İnci Hazal Ayas, MSc

  Gazi University

  STUDY CHAIR

• Meral Boşnak Güçlü, Assoc. Prof

  Gazi University

  STUDY DIRECTOR

• Burcu Camcıoğlu, PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

• Dilek Erer, MD

  Gazi University

  PRINCIPAL INVESTIGATOR

• Abdullah Özer, MD

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 8, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: March 31, 2019
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)