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

NCT ID: NCT04627935

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD patients

Patients with a diagnosis of COPD aged over 60 years

The COPD Assessment Test

Intervention Type BEHAVIORAL

Used to assess symptoms in COPD patients.

Navicular Drop Test

Intervention Type DIAGNOSTIC_TEST

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

International Physical Activity Questionnaires (IPAQ)

Intervention Type 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 and Asthma Fatigue Scale (CAFS)

Intervention Type BEHAVIORAL

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

Saint George Respiratory Questionnaire

Intervention Type BEHAVIORAL

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

Interventions

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The COPD Assessment Test

Used to assess symptoms in COPD patients.

Intervention Type BEHAVIORAL

Navicular Drop Test

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.)
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nilufer Kablan, Asst. Prof.

Role: STUDY_DIRECTOR

Istanbul Sağlık Bilimleri University

Ayca Evkaya Acar, Res. Asst.

Role: PRINCIPAL_INVESTIGATOR

Maltepe University

Locations

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Istanbul Saglık Bilimleri University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Nilufer Kablan, Asst. Prof.

Role: CONTACT

Phone: 05067638556

Email: [email protected]

Ayca Evkaya Acar, Res. Asst.

Role: CONTACT

Phone: 05544263263

Email: [email protected]

Facility Contacts

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Nilufer Kablan, Asst. Prof

Role: primary

Ayca Evkaya Acar, Res. Asst.

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 23258783 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28286249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26251588 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 15143396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14706002 (View on PubMed)

Other Identifiers

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09.2020.766

Identifier Type: -

Identifier Source: org_study_id