Clinical trial NCT05930158: The Effectiveness of Dual-task Exercises in Individuals With COPD
Official title: The Effectiveness of Dual-task Exercises in Individuals With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Healthy
Keywords: COPD
dual-task
balance
walking
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 63
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effect of dual-task performance on motor and cognitive functions and to determine the effect of dual-task exercises given together with the pulmonary rehabilitation program on cardiopulmonary and musculoskeletal parameters in COPD.

The main question\[s\]it aims to answer are:

* Is dual-task performance in individuals with COPD different from healthy individuals?
* Are dual-task exercises affect cardiopulmonary and musculoskeletal parameters in individuals with COPD? Patients will be randomly divided into 2 groups (Pulmonary Rehabilitation Group, Dual Task Exercises Group). 8-week exercise program will include pulmonary rehabilitation and dual-task exercise group will do their walking and cycling exercises as dual task with another cognitive exercise.

Researchers also will compare (Pulmonary Rehabilitation Group, Dual Task Exercises Group) to see if there is a difference in cardiopulmonary and musculoskeletal parameters.

Researchers also will compare \[COPD patients and Healthy Controls\] to see if there is a difference in dual-task performance.

Detailed description: Central nervous system dysfunction is an extrapulmonary complication of chronic obstructive pulmonary disease (COPD). Brain functions, particularly frontal lobe functions, have been shown to be impaired as a result of COPD. Studies have shown that patients with COPD have impaired ability to perform complex multitasking, such as driving or walking, along with a cognitive task. It has also been reported that the time to complete a functional test with a cognitive task is prolonged in patients with COPD. For many activities of daily life, it is very important to perform multiple tasks at the same time (such as maintaining balance with a cognitive task) in patients with COPD. Studies evaluating dual-task performance in COPD patients are limited. Since this is an important clinical issue, the reversibility of this situation should also be investigated. In addition, considering the positive effects of pulmonary rehabilitation on cognitive functions such as planning, selective attention and verbal memory, additional dual-task exercises may be an appropriate treatment method and increase the effectiveness of pulmonary rehabilitation and the quality of life of patients.

The aim of this study is to evaluate the effect of dual-task performance on motor and cognitive functions in COPD and to determine the effect of dual-task exercises given together with the pulmonary rehabilitation program on cardiopulmonary and musculoskeletal parameters.

The research will be carried out at the University of Health Sciences Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital between June 2023 and November 2024. Patients with a diagnosis of COPD who were admitted to Pulmonary Rehabilitation, met the inclusion criteria, and voluntarily agreed to participate in the study will be included. Demographic information (age, occupation, height, body weight, etc.), clinical status (duration of diagnosis, disease severity), medical conditions, exacerbations and hospitalizations of all participants will be recorded. COPD Assessment Test (CAT) will be administered, and dyspnea evaluation will be made with the Modified Medical Research Council Dyspnea Scale (mMRC). Mini-Mental State Examination and Frontal Assessment Battery will be used in the cognitive status evaluation of the patients. For balance evaluation, it will be done with Mini-BESTest: Balance Evaluation Systems Test. Functional balance and mobility assessment will be made with the Timed Up and Go Test and the 10-meter Walk Test, and the tests will be applied twice as both a single task (normal walking) and a dual task (walking and cognitive task). 6 Minute Walk Test will be used in functional capacity evaluation. Quality of life will be assessed with St. George\&#39;s Respiratory Questionnaire (SGRQ). In addition, the results of the Pulmonary Function Test performed during the routine controls of the patients will be taken. Patients will be randomly divided into 2 groups (Pulmonary Rehabilitation Group, Dual Task Exercises Group). Evaluations will be repeated at the end of the 8-week exercise program.

Dual-task performances of healthy individuals with similar demographic characteristics in COPD patients will be compared. For this, the demographic information of healthy volunteers will be recorded, and the Timed Up and Go Test, which will be done as a dual task and a single task, and the 10-meter Walk Test will be evaluated.

SPSS (Statistical Package for Social Sciences) (SPSS Inc, IBM Corp, Armonk, New York) statistical program will be used in the classification of the data to be obtained in the research, using qualitative and quantitative statistical methods. With the values in the 95% confidence interval, the significance will be evaluated at the p\&lt;0.05 level. In the examination of the variables, appropriate statistical tests will be applied depending on the provision of the parametric test conditions.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with COPD
* COPD patients aged 40-75 years
* COPD stable period
* Absence of abnormal laboratory findings
* Not having a mental problem that prevents them from completing the questionnaires to be - used in the research
* No diagnosed cardiac or pulmonary disease for the healthy control group

Exclusion Criteria:

* COPD exacerbation
* Cognitive impairment
* Having a pregnancy status
* Having advanced age
* Having ischemic heart disease
* Kyphoscoliosis, advanced postural disorder
* Having an orthopedic disability and amputation surgery
* Presence of any neurological disease that causes balance problems
* Having a different respiratory disease that impairs respiratory functions
* Pulmonary embolism
* Pleural effusion
* Heart failure

Primary outcomes:
measure: Change in Mini-Mental State Exam Score
timeFrame: Baseline and the end of the 8 weeks exercise program
measure: Change in Frontal Assessment Battery Score
timeFrame: Baseline and the end of the 8 weeks exercise program
measure: Change in dual-task performance with Timed Up and Go Test
timeFrame: Baseline and the end of the 8 weeks exercise program
measure: Change in dual-task performance with 10 meter Walk Test
timeFrame: Baseline and the end of the 8 weeks exercise program
Secondary outcomes:
measure: Change in COPD Assessment Test
timeFrame: Baseline and the end of the 8 weeks exercise program
measure: Change in Dyspnea
timeFrame: Baseline and the end of the 8 weeks exercise program
measure: Change in Balance
timeFrame: Baseline and the end of the 8 weeks exercise program
measure: Change in Timed Up and Go Test
timeFrame: Baseline and the end of the 8 weeks exercise program
measure: Change in 10-meter Walk
timeFrame: Baseline and the end of the 8 weeks exercise program
measure: Change in Functional Capacity
timeFrame: Baseline and the end of the 8 weeks exercise program
measure: Change in Quality of Life
timeFrame: Baseline and the end of the 8 weeks exercise program
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital
Study officials:
affiliation: Marmara University
name: Aysel Yıldız Özer, PhD
role: STUDY_DIRECTOR
References: