The Effect of Foot Deformities on Physical Activity, Fatigue Level and Quality of Life in Elderly COPD Patients

NCT04627935 | Unknown

• 1 other identifier: 09.2020.766
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of changes in foot structure on physical activity level, fatigue and quality of life in COPD patients.

Conditions

Chronic Obstructive Pulmonary Disease; Foot Deformities; Quality of Life; Activity, Motor; Fatigue

Keywords

Chronic Obstructive Pulmonary Disease; Foot deformities; quality of life; physical activity; fatigue; geriatric patient

Outcome Measures

Primary Outcomes (1)

• Navicular Drop Test

  It is the test used to measure the amount of pronation in the foot.

  Day 0

Secondary Outcomes (4)

• The COPD Assessment Test

  Day 0

• International Physical Activity Questionnaires (IPAQ)

  Day 0

• COPD and Asthma Fatigue Scale (CAFS)

  Day 0

• Saint George Respiratory Questionnaire

  Day 0

Study Arms (1)

COPD patients

Patients with a diagnosis of COPD aged over 60 years

Behavioral: The COPD Assessment Test; Diagnostic Test: Navicular Drop Test; Behavioral: International Physical Activity Questionnaires (IPAQ); Behavioral: COPD and Asthma Fatigue Scale (CAFS); Behavioral: Saint George Respiratory Questionnaire

Interventions

The COPD Assessment Test BEHAVIORAL

Used to assess symptoms in COPD patients.

COPD patients

Navicular Drop Test DIAGNOSTIC_TEST

It is the test used to measure the amount of pronation in the foot.

COPD patients

International Physical Activity Questionnaires (IPAQ) BEHAVIORAL

The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.

COPD patients

COPD and Asthma Fatigue Scale (CAFS) BEHAVIORAL

CAFS is a comprehensive, brief, patient-centered questionnaire developed to capture fatigue experienced by patients with asthma or COPD.

COPD patients

Saint George Respiratory Questionnaire BEHAVIORAL

Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.

COPD patients

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

77 COPD patients, over 60 years of age

You may qualify if:

• Confirmed diagnosis of COPD
• Age over 60

You may not qualify if:

• Having an orthopedic or neurological disorder that affects the walking pattern
• Having a peripheral vascular disease
• Being diagnosed with Diabetes Mellitus
• Having systemic diseases such as arthritis
• Having a previous history of foot-ankle fractures
• Having a dermatological disease (fungal and bacterial infection etc.)

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Istanbul Saglık Bilimleri University

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Jones PW, Adamek L, Nadeau G, Banik N. Comparisons of health status scores with MRC grades in COPD: implications for the GOLD 2011 classification. Eur Respir J. 2013 Sep;42(3):647-54. doi: 10.1183/09031936.00125612. Epub 2012 Dec 20.

  PMID: 23258783 BACKGROUND

• de Sa RB, Pessoa MF, Cavalcanti AGL, Campos SL, Amorim C, Dornelas de Andrade A. Immediate effects of respiratory muscle stretching on chest wall kinematics and electromyography in COPD patients. Respir Physiol Neurobiol. 2017 Aug;242:1-7. doi: 10.1016/j.resp.2017.03.002. Epub 2017 Mar 10.

  PMID: 28286249 BACKGROUND

• Sun KS, Lin MS, Chen YJ, Chen YY, Chen SC, Chen W. Is asymptomatic peripheral arterial disease associated with walking endurance in patients with COPD? Int J Chron Obstruct Pulmon Dis. 2015 Jul 29;10:1487-92. doi: 10.2147/COPD.S85430. eCollection 2015.

  PMID: 26251588 BACKGROUND

• Atasever A, Erdinc E. [Quality of life in COPD]. Tuberk Toraks. 2003;51(4):446-55. Turkish.

  PMID: 15143396 BACKGROUND

• Theander K, Unosson M. Fatigue in patients with chronic obstructive pulmonary disease. J Adv Nurs. 2004 Jan;45(2):172-7. doi: 10.1046/j.1365-2648.2003.02878.x.

  PMID: 14706002 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Foot Deformities; Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases; Behavior; Signs and Symptoms

Study Officials

• Nilufer Kablan, Asst. Prof.

  Istanbul Sağlık Bilimleri University

  STUDY DIRECTOR

• Ayca Evkaya Acar, Res. Asst.

  Maltepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nilufer Kablan, Asst. Prof.

CONTACT

05067638556; niluferkablan@yahoo.com

Ayca Evkaya Acar, Res. Asst.

CONTACT

05544263263; ayca.evkaya@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 13, 2020
• Study Start: March 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 30, 2021
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

TU (1)