Clinical trial NCT04627935: The Effect of Foot Deformities on Physical Activity, Fatigue Level and Quality of Life in Elderly COPD Patients
Official title: The Effect of Foot Deformities on Physical Activity, Fatigue Level and Quality of Life in Elderly COPD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 77
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 77 COPD patients, over 60 years of age

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.

Eligibility 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.)

Primary outcomes:
measure: Navicular Drop Test
timeFrame: Day 0
Secondary outcomes:
measure: The COPD Assessment Test
timeFrame: Day 0
measure: International Physical Activity Questionnaires (IPAQ)
timeFrame: Day 0
measure: COPD and Asthma Fatigue Scale (CAFS)
timeFrame: Day 0
measure: Saint George Respiratory Questionnaire
timeFrame: Day 0
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Saglık Bilimleri University
Study officials:
affiliation: Istanbul Sağlık Bilimleri University
name: Nilufer Kablan, Asst. Prof.
role: STUDY_DIRECTOR
affiliation: Maltepe University
name: Ayca Evkaya Acar, Res. Asst.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: Atasever A, Erdinc E. [Quality of life in COPD]. Tuberk Toraks. 2003;51(4):446-55. Turkish.
citation: 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.