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

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

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.

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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

Resource links provided by the National Library of Medicine


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.




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.



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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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04627935


Contacts
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Contact: Nilufer Kablan, Asst. Prof. 05067638556 niluferkablan@yahoo.com
Contact: Ayca Evkaya Acar, Res. Asst. 05544263263 ayca.evkaya@gmail.com

Locations
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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
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Study Director: Nilufer Kablan, Asst. Prof. Istanbul Sağlık Bilimleri University
Principal Investigator: Ayca Evkaya Acar, Res. Asst. Maltepe University
Publications:
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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    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020

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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:
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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