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

NCT ID: NCT03458754

Last Updated: 2020-11-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-03-31

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)

Conditions

Peripheral Arterial Disease

Keywords

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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)

No interventions assigned to this group

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)

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Meral Boşnak Güçlü

Assoc. Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İnci Hazal Ayas, MSc

Role: STUDY_CHAIR

Gazi University

Meral Boşnak Güçlü, Assoc. Prof

Role: STUDY_DIRECTOR

Gazi University

Burcu Camcıoğlu, PhD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Dilek Erer, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Abdullah Özer, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University

Ankara, , Turkey (Türkiye)

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

Yenimahalle, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 23044259 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21690489 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24690492 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27749546 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9575600 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18771878 (View on PubMed)

Other Identifiers

Gazi University 9

Identifier Type: -

Identifier Source: org_study_id