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

• Conditions: Chronic Obstructive Pulmonary Disease; Activity, Motor; Foot Deformities; Quality of Life; Fatigue
• Interventions: 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

• Registration Number: NCT04627935
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-08
• Study First Submitted QC: 2020-11-08
• Last Update Submitted: 2020-11-08
• Study First Posted: 2020-11-13
• Last Update Posted: 2020-11-13
• Study Start: 2021-03-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 77

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD patients	The COPD Assessment Test	Patients with a diagnosis of COPD aged over 60 years
COPD patients	Navicular Drop Test	Patients with a diagnosis of COPD aged over 60 years
COPD patients	International Physical Activity Questionnaires (IPAQ)	Patients with a diagnosis of COPD aged over 60 years
COPD patients	COPD and Asthma Fatigue Scale (CAFS)	Patients with a diagnosis of COPD aged over 60 years
COPD patients	Saint George Respiratory Questionnaire	Patients with a diagnosis of COPD aged over 60 years

Primary Outcome Measures

Name	Time	Method
Navicular Drop Test	Day 0	It is the test used to measure the amount of pronation in the foot.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istanbul Saglık Bilimleri University; 🇹🇷 Istanbul, Turkey