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

• ClinicalTrials.gov Identifier: NCT04627935
• Recruitment Status: Not yet recruiting
• First Posted: November 13, 2020
• Last Update Posted: November 13, 2020
• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Information provided by (Responsible Party): Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study Description

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.

Condition or disease	Intervention/treatment
Chronic Obstructive Pulmonary Disease; Foot Deformities; Quality of Life; Activity, Motor; Fatigue	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

Detailed Description:

Chronic obstructive pulmonary disease (COPD) is usually a progressive disease associated with the increased chronic inflammatory response of the airways and lungs to the toxic effects of harmful gases and particles. It causes pathological changes such as increased secretion production in the airways, epithelial changes, inflammation, smooth muscle hypertrophy, and hyperplasia in the submucosal glands. Hyperinflammation in the lungs results in muscle atrophy, shortening of the respiratory muscles, and increased respiratory workload. On the other hand, the increase in pro-inflammatory plasma cytokine levels seen in the systemic circulation causes oxidative stress, leading to the development of musculoskeletal system disorders and a decrease in functional capacity. Pulmonary dysfunction and increased dyspnea lead to a decrease in physical condition, physical exercise tolerance, and activity, while the decrease in muscle mass results in atrophy in the peripheral extremities.

Age and gender are cited as major risk factors for COPD. Therefore, lower extremity atrophy, which is seen in peripheral extremities and increases with aging, causes foot dysfunctions. Considering that the ability of elderly people to maintain their independence is related to a good level of consciousness and ongoing ambulation, and the frequency of foot problems seen in elderly people is approximately twice as high as the general population, foot problems seen in elderly individuals are very important for this group. In particular, the decrease in foot mobility and the fall of the medial longitudinal arch negatively affect the absorption of shocks during heel strike and foot flat and the momentum of the trunk forward. This situation may result in the expenditure of energy above normal and deterioration of balance while ensuring the proper transfer of body weight. All of these cause early fatigue and a decrease in the quality of life in the individual. In the literature, foot deformities in elderly healthy individuals and the parameters these deformities will affect people are stated. However, there is no study examining the effects of foot deformities on physical activity, fatigue, and quality of life in elderly COPD patients.

Study Design

• Study Type: Observational
• Estimated Enrollment: 77 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Effect of Foot Deformities on Physical Activity, Fatigue Level and Quality of Life in Elderly COPD Patients
• Estimated Study Start Date: March 1, 2021
• Estimated Primary Completion Date: September 1, 2021
• Estimated Study Completion Date: December 30, 2021

Groups and Cohorts

Group/Cohort

Intervention/treatment

COPD patients; Patients with a diagnosis of COPD aged over 60 years

Behavioral: The COPD Assessment Test; Used to assess symptoms in COPD patients.; Diagnostic Test: Navicular Drop Test; It is the test used to measure the amount of pronation in the foot.; Behavioral: International Physical Activity Questionnaires (IPAQ); 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.; Behavioral: COPD and Asthma Fatigue Scale (CAFS); CAFS is a comprehensive, brief, patient-centered questionnaire developed to capture fatigue experienced by patients with asthma or COPD.; Behavioral: Saint George Respiratory Questionnaire; Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.

Outcome Measures

Primary Outcome Measures :

1. Navicular Drop Test [ Time Frame: Day 0 ]
   It is the test used to measure the amount of pronation in the foot.

Secondary Outcome Measures :

1. The COPD Assessment Test [ Time Frame: Day 0 ]
   Used to assess symptoms in COPD patients.
2. International Physical Activity Questionnaires (IPAQ) [ Time Frame: Day 0 ]
   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.
3. COPD and Asthma Fatigue Scale (CAFS) [ Time Frame: Day 0 ]
   CAFS is a comprehensive, brief, patient-centered questionnaire developed to capture fatigue experienced by patients with asthma or COPD.
4. Saint George Respiratory Questionnaire [ Time Frame: Day 0 ]
   Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 100 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

77 COPD patients, over 60 years of age

Criteria

Inclusion Criteria:

• Confirmed diagnosis of COPD
• Age over 60

Exclusion Criteria:

• 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.)

Contacts and Locations

Contacts

Contact: Nilufer Kablan, Asst. Prof.; 05067638556; niluferkablan@yahoo.com

Contact: Ayca Evkaya Acar, Res. Asst.; 05544263263; ayca.evkaya@gmail.com

Locations

Turkey

Istanbul Saglık Bilimleri University

Istanbul, Turkey

Contact: Nilufer Kablan, Asst. Prof 05067638556 niluferkablan@yahoo.com

Contact: Ayca Evkaya Acar, Res. Asst. 05544263263 ayca.evkaya@gmail.com

Sub-Investigator: Sibel Gayretli Atan, Lecturer

Sponsors and Collaborators

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

• Study Director: Nilufer Kablan, Asst. Prof.; Istanbul Sağlık Bilimleri University
• Principal Investigator: Ayca Evkaya Acar, Res. Asst.; Maltepe University

More Information

Publications:

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.

de Sá 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.

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.

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

Theander K, Unosson M. Fatigue in patients with chronic obstructive pulmonary disease. J Adv Nurs. 2004 Jan;45(2):172-7.

• Responsible Party: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• ClinicalTrials.gov Identifier: NCT04627935
• Other Study ID Numbers: 09.2020.766
• First Posted: November 13, 2020
• Last Update Posted: November 13, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey:

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

Additional relevant MeSH terms:

Foot Deformities; Foot Deformities, Congenital; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Congenital Abnormalities; Fatigue; Respiratory Tract Diseases; Musculoskeletal Diseases; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities