Clinical trial NCT04841005: Investigation of Square Step Exercise Applied by Telerehabilitation in Chronic Obstructive Pulmonary Disease Patients
Official title: Investigation of the Effect of Square-Step Exercise Applied by Telerehabilitation on Cognitive Functions, Balance and Quality of Life in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Cognitive Impairment
Balance; Distorted
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Exercises will be applied with the telerehabilitation method to the individuals included in the study. Video and audio communication will be provided by free and widely used programs such as Whatsapp or Telegram. Pulse oximetry, tripod and exercise material will be given to each individual included in the study by the researcher. Individuals included in the study will be randomly divided into two groups. Exercises in both groups will be done 3 days a week for 8 weeks. Before and after each exercise session, the heart rate and oxygen saturation values of the patients will be measured by pulse oximetry, and their perception of dyspnea and leg fatigue according to the Borg scale will be recorded. The first and last evaluation of individuals will be done face to face.
Primary purpose: TREATMENT

Brief summary: COPD is a progressive disease associated with systemic inflammation, with many extrapulmonary outcomes such as cognitive impairment. Most of the daily activities involve doing several tasks at the same time, such as walking while talking or avoiding obstacles.

Detailed description: The most prominent independent risk factor for cognitive impairment in COPD patients is reduced oxygen availability as a result of lung dysfunction. The prevalence of cognitive impairment in COPD patients ranges from 10% to 61%. A wide variety of tools have been developed for screening cognitive functions. The most widely used tests covering multiple cognitive domains are the Mini Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA).

When two tasks are performed at the same time, they compete for sources of attention, resulting in decreased performance on one or two tasks. Balance or postural control is a complex skill required for independent mobility and preventing falls. Balance performance naturally decreases with age; however, certain conditions are associated with more pronounced and rapid declines. Balance problems and fall risk are increased in COPD patients.From this perspective aim of this study is to assess the effect of square-step exercise and strengthening exercise applied with telerehabilitation on cognitive status and balance in patients with COPD.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with mild / moderate COPD by Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Chest Diseases.
* Mini mental score is 23 or higher
* Being between the ages of 50-80
* Spirometric evaluation result is forced expiratory volume at one second / Forced vital capacity \<70% and airflow restriction is 50% forced expiratory volume at one second \<80% (expected) degree compared to post-bronchodilator forced expiratory volume at one second.
* No drug change or antibiotic use due to acute exacerbation for at least three weeks

Exclusion Criteria:

* Individuals who need continuous oxygen support
* Individuals with partial pressure of carbon dioxide≥70 mmHg
* Having a history of uncontrolled illness that may affect cognitive skills
* Have uncorrected vision and hearing impairment
* Having kyphoscoliosis and/or severe postural impairment
* Having additional risk factors (stroke, neurological disease, dementia, depression, postural hypotension, diaphragm dysfunction)

Primary outcomes:
measure: Change of the point in the cognitive test
timeFrame: Two measurements: At the beginning and after eight weeks
measure: Measurement of change in postural stability
timeFrame: Two measurements: At the beginning and after eight weeks
measure: Measurement of change in functional balance
timeFrame: Two measurements: At the beginning and after eight weeks
measure: Measuring change in quality of life
timeFrame: Two measurements: At the beginning and after eight weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: At the enrollment process
Secondary outcomes:
measure: Assessment of the COPD
timeFrame: At the enrollment process
measure: Assessment of comorbidities
timeFrame: At the enrollment process
measure: Evaluation of shortness of breath
timeFrame: At the enrollment process
measure: 1 Minute Sit and Stand Test
timeFrame: Two measurements: At the beginning and after eight weeks
measure: Forced expiratory volume in the first second
timeFrame: At the enrollment process
measure: Forced vital capacity
timeFrame: At the enrollment process
measure: The ratio of FEV1 to FVC
timeFrame: At the enrollment process
measure: Mini mental test
timeFrame: At the enrollment process
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University, Faculty of Health Sciences, Physiotherapy and rehabilitation department
Study officials:
affiliation: BAIBU, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
name: Alp Özel, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: BAIBU, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
name: Eylem Tütün Yümin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: BAIBU, Faculty of Medicine, Department of Chest Diseases
name: Suat Konuk, MD
role: PRINCIPAL_INVESTIGATOR
References: