The Effectiveness of Dual-task Exercises in Individuals With COPD

NCT05930158 | Completed DMC

• 1 other identifier: 136
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Healthy

Keywords

COPD; dual-task; balance; walking

Outcome Measures

Primary Outcomes (4)

• Change in Mini-Mental State Exam Score

  Mini-Mental State Exam will be used for cognitive status assessment. Mini-Mental State Exam is evaluated out of a total score of 30. Traditionally, scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment. The assessment can be completed in 10 minutes. Change from baseline at the end of 8 weeks exercise program will be assessed. Healthy Controls' assessment will be only at the baseline.

  Baseline and the end of the 8 weeks exercise program

• Change in Frontal Assessment Battery Score

  The Frontal Assessment Battery will be used for cognitive status assessment. It has 6 items and each item has a score of 0-3. A higher score means better performance. The assessment can be completed in 15 minutes. Change from baseline at the end of 8 weeks exercise program will be assessed. Healthy Controls' assessment will be only at the baseline.

  Baseline and the end of the 8 weeks exercise program

• Change in dual-task performance with Timed Up and Go Test

  Dual-task Assessment will be done with Timed Up and Go Test. While TUG is being performed, the participant initially sits on the chair, gets up from the chair with the start command 3 m. He goes to the marked place ahead, returns, and sits down on the chair again. Patients will be given cognitive tasks during the walking test, while the elapsed time is recorded. The assessment can be completed in 10 minutes. Change from baseline at the end of 8 weeks exercise program will be assessed. Healthy Controls' assessment will be only at the baseline.

  Baseline and the end of the 8 weeks exercise program

• Change in dual-task performance with 10 meter Walk Test

  Dual-task Assessment will be done with Timed Up and Go Test and 10 meter Walk Test. For 10-meter Walk Test participants are asked to walk 14m during the test. The first 2 m section of the walkway to be applied is the acceleration section, and the last 2 m section is the deceleration section. Patients will be given cognitive tasks during walking test, while the elapsed time is recorded. The assessment can be completed in 10 minutes. Change from baseline at the end of 8 weeks exercise program will be assessed. Healthy Controls' assessment will be only at the baseline.

  Baseline and the end of the 8 weeks exercise program

Secondary Outcomes (7)

• Change in COPD Assessment Test

  Baseline and the end of the 8 weeks exercise program

• Change in Dyspnea

  Baseline and the end of the 8 weeks exercise program

• Change in Balance

  Baseline and the end of the 8 weeks exercise program

• Change in Timed Up and Go Test

  Baseline and the end of the 8 weeks exercise program

• Change in 10-meter Walk

  Baseline and the end of the 8 weeks exercise program

Study Arms (3)

Pulmonary Rehabilitation Group

ACTIVE COMPARATOR

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.

Other: Pulmonary Rehabilitation

Dual Task Exercises Group

EXPERIMENTAL

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.

Other: Dual Task Exercises; Other: Pulmonary Rehabilitation

Healthy Controls

NO INTERVENTION

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.

Interventions

Dual Task Exercises 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.

Dual Task Exercises Group

Pulmonary Rehabilitation 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; Pulmonary Rehabilitation Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40390096 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aysel Yıldız Özer, PhD

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc, PT

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 5, 2023
• Study Start: October 13, 2023
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)