The Effectiveness of Dual-task Exercises in Individuals With COPD

NCT ID: NCT05930158

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-13

Study Completion Date

2025-08-21

Brief Summary

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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

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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\'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\<0.05 level. In the examination of the variables, appropriate statistical tests will be applied depending on the provision of the parametric test conditions.

Conditions

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COPD Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pulmonary Rehabilitation Group

Patients in this group will continue the classic rehabilitation programs determined in the Pulmonary Rehabilitation Unit. The program will continue for 8 weeks, 2 sessions per week.

Group Type ACTIVE_COMPARATOR

Pulmonary Rehabilitation

Intervention Type OTHER

Pulmonary Rehabilitation content; relaxation exercises, stretching exercises, strengthening exercises, walking exercises, cycling exercises, balance exercises. Exercise intensity will be planned as moderate intensity. Walking and cycling exercises will have warm-up and cool-down periods.

Dual Task Exercises Group

The patients in this group will continue the determined rehabilitation programs, during the walking and balance exercises in the program, they will also do the cognitive exercises that are different from the patients in the Pulmonary Rehabilitation group. The program will continue for 8 weeks, 2 sessions per week. Walking exercises and balance exercises will be planned for 15 minutes each. The intensity of the walking exercise will be planned as moderate intensity according to the results of 6 MWT, it will start with the warm-up period and end with a cool-down. A treadmill will be used for the exercise.

Balance exercises program will consist of tandem walking (walking with the heel touching the toe of the other foot), standing on one foot (eyes open-closed), walking in a straight line, and standing on soft ground with eyes closed.

Cognitive exercises to be added during walking and balance exercises will be given as a dual task.

Group Type EXPERIMENTAL

Dual Task Exercises

Intervention Type OTHER

Cognitive exercises to be added during walking and balance exercises will be given as a dual task. Cognitive exercises will consist of exercises for memory, executive functions, calculation, information processing speed (reaction time) and working memory areas. Cognitive exercises such as grouping the words given, giving appropriate answers to the simple situations described, simple addition, subtraction, multiplication, and asking the words that the patient is asked to remember before the exercise will be used. Cognitive exercises will be performed simultaneously with walking and balance exercises.

Pulmonary Rehabilitation

Intervention Type OTHER

Pulmonary Rehabilitation content; relaxation exercises, stretching exercises, strengthening exercises, walking exercises, cycling exercises, balance exercises. Exercise intensity will be planned as moderate intensity. Walking and cycling exercises will have warm-up and cool-down periods.

Healthy Controls

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dual Task Exercises

Cognitive exercises to be added during walking and balance exercises will be given as a dual task. Cognitive exercises will consist of exercises for memory, executive functions, calculation, information processing speed (reaction time) and working memory areas. Cognitive exercises such as grouping the words given, giving appropriate answers to the simple situations described, simple addition, subtraction, multiplication, and asking the words that the patient is asked to remember before the exercise will be used. Cognitive exercises will be performed simultaneously with walking and balance exercises.

Intervention Type OTHER

Pulmonary Rehabilitation

Pulmonary Rehabilitation content; relaxation exercises, stretching exercises, strengthening exercises, walking exercises, cycling exercises, balance exercises. Exercise intensity will be planned as moderate intensity. Walking and cycling exercises will have warm-up and cool-down periods.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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begumunlu

Msc, PT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysel Yıldız Özer, PhD

Role: STUDY_DIRECTOR

Marmara University

Locations

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University of Health Sciences Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Unlu B, Yildiz Ozer A, Ozmen I, Polat MG. The effectiveness of dual-task exercises in individuals with chronic obstructive pulmonary disease: a study protocol for a randomized controlled trial. Trials. 2025 May 19;26(1):164. doi: 10.1186/s13063-025-08854-2.

Reference Type DERIVED
PMID: 40390096 (View on PubMed)

Other Identifiers

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136

Identifier Type: -

Identifier Source: org_study_id

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