Investigation of Square Step Exercise Applied by Telerehabilitation in Chronic Obstructive Pulmonary Disease Patients (COPD)
Primary Purpose
COPD, Cognitive Impairment, Balance; Distorted
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Square-Step Exercise Training
Strengthening Exercise Training
Sponsored by

About this trial
This is an interventional treatment trial for 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)
Sites / Locations
- Bolu Abant Izzet Baysal University, Faculty of Health Sciences, Physiotherapy and rehabilitation department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Square-Step Exercise group
Strengthening Exercise Group
Arm Description
Square-step exercise for 8 weeks will be applied under the supervision of a physiotherapist.
Strengthening exercise for 8 weeks will be applied under the supervision of a physiotherapist.
Outcomes
Primary Outcome Measures
Change of the point in the cognitive test
Montreal Cognitive Assessment will be used to evaluate cognitive impairment. The application time of the single-page scale is approximately 10 minutes and includes 6 cognitive functions.Cognitive functions evaluated in the scale are as follows: 1. Memory 2. Visual-spatial skills 3. Executive functions, 4. Attention, concentration and working memory tasks, 5. Language, 6. Orientation. The lowest score that can be obtained from the scale is 0, the highest score is 30.
Measurement of change in postural stability
Postural stability is assessed using the Biodex Balance System. It consists of a mobile platform with 20 degrees of inclination in all directions and 12 levels of difficulty. With this system, balance is evaluated thanks to circular platforms that can oscillate simultaneously in the general, front-rear and left-right axes. The right-left stability indices are derived from the platform angular displacement in the frontal plane, while the anteroposterior angular displacement represents the platform displacement in the sagittal plane.
Measurement of change in functional balance
The Balance Evaluation Systems Test (BESTest) will be used to evaluate functional balance. BESTest examines the balance in 6 sections in order to reveal whether the special balance control systems, which are defined as biomechanical structures, stability limits / verticality, intuitive postural adjustments, postural responses, sensory orientation and walking stability, function adequately. Since some of the tasks of BESTest have two subtitles, right side and left side, the patient is evaluated under 36 titles in total. In a sequential scale where each title is scored at 4 levels, 0 represents the worst performance, 3: the best performance. The total score of the test, which has a maximum of 108 points, can be calculated separately by calculating the percentage at the end of each section, as well as calculating the percentage of the total score.
Measuring change in quality of life
St George's Respiratory Questionnaire (SGRQ) has been the most widely used quality of life measurement designed to evaluate the quality of life in lung diseases. SGRQ has distinctive (able to distinguish between different severity levels between patients) and descriptive (can detect disease progression and changes with treatment). The score range ranges from 0 (excellent health) to 100 (most severe disease) and the minimum clinically significant change is considered to be 4 units. This survey has good reproducibility in the short term. It consists of 50 questions in total. The numerical evaluation of the questionnaire is calculated in 4 separate sections as symptom score, activity score, impact score and total score.
Hospital Anxiety and Depression Scale
It was developed to screen mood disorders in groups with a medical illness. It is a scale filled by the patient. It consists of 14 items. Substances contain 4 properties. Depression and anxiety are tried to be evaluated with the help of two subscales. The 7-item depression subscale has a scoring system between 0 and 21. The threshold value indicates "Normal" between 0-7, "Mild" between 8-10, "Moderate" between 11-14, "Severe" between 15-21.
Secondary Outcome Measures
Assessment of the COPD
COPD Assessment Test (CAT) consists of 8 questions. It was developed to reveal how patients' quality of life is affected by COPD. Each question is scored from 0 to 5, with a total score between 0 and 40. Score 0 represents the best 40 points the worst health condition. The questions were intended to cover the patients' shortness of breath, cough, sputum spitting and wheezing, as well as systemic symptoms such as fatigue and sleepiness.
Assessment of comorbidities
The Charlson Comorbidity Index is a widely used index in many disease groups in which many potential comorbidity variables are evaluated and the relative risk is measured by giving different scores. The index consists of 19 different items. These scores given to comorbid diseases are determined according to the relative risk values of the diseases.
Evaluation of shortness of breath
The Modified Medical Research Council Dyspnoea Scale contains 5 statements about patients' dyspnea and categorizes their dyspnea level into a 0-4 point category. Evaluates shortness of breath and activity limitation in patients
1 Minute Sit and Stand Test
The ability to stand up from a chair is an important component of maintaining independence among seniors, as this movement depends on stability and balance. The 1-minute get up and sit test is performed with a 46 cm high chair as standard, without an armrest. After the start command, it is checked whether a sit-to-sit sequence is obtained to stand up and sit from each chair. The number of cycles performed exactly after 1 minute makes up the score.
Forced expiratory volume in the first second
Forced expiratory volume in the first second (FEV1)
Forced vital capacity
Forced vital capacity (FVC)
The ratio of FEV1 to FVC
The ratio of FEV1 to FVC
Mini mental test
Although this test has limited specificity in terms of differentiating clinical syndromes, it is a short, useful and standardized method that can be used to determine the cognitive level globally. It consists of eleven items grouped under five main headings: orientation, attention and calculation, memory, and language. The test is evaluated over a total score of 30. The total score is obtained by summing the points the patient obtains from each item. The cut-off score for mild and moderate dementia in our country is calculated as 23.
Full Information
NCT ID
NCT04841005
First Posted
April 2, 2021
Last Updated
February 15, 2022
Sponsor
Abant Izzet Baysal University
1. Study Identification
Unique Protocol Identification Number
NCT04841005
Brief Title
Investigation of Square Step Exercise Applied by Telerehabilitation in Chronic Obstructive Pulmonary Disease Patients
Acronym
COPD
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Cognitive Impairment, Balance; Distorted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Square-Step Exercise group
Arm Type
Experimental
Arm Description
Square-step exercise for 8 weeks will be applied under the supervision of a physiotherapist.
Arm Title
Strengthening Exercise Group
Arm Type
Experimental
Arm Description
Strengthening exercise for 8 weeks will be applied under the supervision of a physiotherapist.
Intervention Type
Other
Intervention Name(s)
The Square-Step Exercise Training
Intervention Description
The Square-Step Exercise is instructed to walk according to the step pattern shown on a 100 * 250 cm mat, divided into 40 squares of 25 cm each. It includes forward, backward, lateral and diagonal steps, and step patterns are progressively made more complex. Each pattern consists of two to 16 steps; Individuals are asked to repeat the step pattern until they reach the end of the mat. Each step pattern is repeated 4-10 times to ensure that individuals can complete the pattern. The individuals included in the study will exercise in easy-difficulty patterns for the first 2 weeks, medium-difficulty patterns in the 3rd and 4th weeks, medium and advanced patterns in the 5th and 6th weeks, and advanced patterns in the 7th and 8th weeks. The square-step exercise group will perform 15 minutes of warm-up exercise, 30 minutes of progressive square-step exercise, and 10 minutes of cool-down exercise accompanied by a physiotherapist, 3 days a week.
Intervention Type
Other
Intervention Name(s)
Strengthening Exercise Training
Intervention Description
Thera-Band brand elastic bands will be used to apply resistance in strengthening training. To determine the intensity of the exercise, the perceived difficulty level after 15 repetitions with the elastic band will be evaluated with the Borg scale. If the perceived difficulty level is at the level of 12-14 (slightly difficult), it will be considered as the starting difficulty level.In the strengthening exercise group will perform, shoulder abduction, shoulder press after elbow flexion, horizontal abduction, punching with an elastic band, triceps strengthening, external rotation of the shoulder, hip abduction with external rotation and sit-to-stand exercises for 8 weeks, 3 days / week , 3 sets / sessions, 8-12 repetitions. For each exercise, it will be applied as 8 repetitions in the initial workload. In the next exercise sessions, the number of repetitions will be increased until the patient can comfortably perform 12 repetitions with the same load.
Primary Outcome Measure Information:
Title
Change of the point in the cognitive test
Description
Montreal Cognitive Assessment will be used to evaluate cognitive impairment. The application time of the single-page scale is approximately 10 minutes and includes 6 cognitive functions.Cognitive functions evaluated in the scale are as follows: 1. Memory 2. Visual-spatial skills 3. Executive functions, 4. Attention, concentration and working memory tasks, 5. Language, 6. Orientation. The lowest score that can be obtained from the scale is 0, the highest score is 30.
Time Frame
Two measurements: At the beginning and after eight weeks
Title
Measurement of change in postural stability
Description
Postural stability is assessed using the Biodex Balance System. It consists of a mobile platform with 20 degrees of inclination in all directions and 12 levels of difficulty. With this system, balance is evaluated thanks to circular platforms that can oscillate simultaneously in the general, front-rear and left-right axes. The right-left stability indices are derived from the platform angular displacement in the frontal plane, while the anteroposterior angular displacement represents the platform displacement in the sagittal plane.
Time Frame
Two measurements: At the beginning and after eight weeks
Title
Measurement of change in functional balance
Description
The Balance Evaluation Systems Test (BESTest) will be used to evaluate functional balance. BESTest examines the balance in 6 sections in order to reveal whether the special balance control systems, which are defined as biomechanical structures, stability limits / verticality, intuitive postural adjustments, postural responses, sensory orientation and walking stability, function adequately. Since some of the tasks of BESTest have two subtitles, right side and left side, the patient is evaluated under 36 titles in total. In a sequential scale where each title is scored at 4 levels, 0 represents the worst performance, 3: the best performance. The total score of the test, which has a maximum of 108 points, can be calculated separately by calculating the percentage at the end of each section, as well as calculating the percentage of the total score.
Time Frame
Two measurements: At the beginning and after eight weeks
Title
Measuring change in quality of life
Description
St George's Respiratory Questionnaire (SGRQ) has been the most widely used quality of life measurement designed to evaluate the quality of life in lung diseases. SGRQ has distinctive (able to distinguish between different severity levels between patients) and descriptive (can detect disease progression and changes with treatment). The score range ranges from 0 (excellent health) to 100 (most severe disease) and the minimum clinically significant change is considered to be 4 units. This survey has good reproducibility in the short term. It consists of 50 questions in total. The numerical evaluation of the questionnaire is calculated in 4 separate sections as symptom score, activity score, impact score and total score.
Time Frame
Two measurements: At the beginning and after eight weeks
Title
Hospital Anxiety and Depression Scale
Description
It was developed to screen mood disorders in groups with a medical illness. It is a scale filled by the patient. It consists of 14 items. Substances contain 4 properties. Depression and anxiety are tried to be evaluated with the help of two subscales. The 7-item depression subscale has a scoring system between 0 and 21. The threshold value indicates "Normal" between 0-7, "Mild" between 8-10, "Moderate" between 11-14, "Severe" between 15-21.
Time Frame
At the enrollment process
Secondary Outcome Measure Information:
Title
Assessment of the COPD
Description
COPD Assessment Test (CAT) consists of 8 questions. It was developed to reveal how patients' quality of life is affected by COPD. Each question is scored from 0 to 5, with a total score between 0 and 40. Score 0 represents the best 40 points the worst health condition. The questions were intended to cover the patients' shortness of breath, cough, sputum spitting and wheezing, as well as systemic symptoms such as fatigue and sleepiness.
Time Frame
At the enrollment process
Title
Assessment of comorbidities
Description
The Charlson Comorbidity Index is a widely used index in many disease groups in which many potential comorbidity variables are evaluated and the relative risk is measured by giving different scores. The index consists of 19 different items. These scores given to comorbid diseases are determined according to the relative risk values of the diseases.
Time Frame
At the enrollment process
Title
Evaluation of shortness of breath
Description
The Modified Medical Research Council Dyspnoea Scale contains 5 statements about patients' dyspnea and categorizes their dyspnea level into a 0-4 point category. Evaluates shortness of breath and activity limitation in patients
Time Frame
At the enrollment process
Title
1 Minute Sit and Stand Test
Description
The ability to stand up from a chair is an important component of maintaining independence among seniors, as this movement depends on stability and balance. The 1-minute get up and sit test is performed with a 46 cm high chair as standard, without an armrest. After the start command, it is checked whether a sit-to-sit sequence is obtained to stand up and sit from each chair. The number of cycles performed exactly after 1 minute makes up the score.
Time Frame
Two measurements: At the beginning and after eight weeks
Title
Forced expiratory volume in the first second
Description
Forced expiratory volume in the first second (FEV1)
Time Frame
At the enrollment process
Title
Forced vital capacity
Description
Forced vital capacity (FVC)
Time Frame
At the enrollment process
Title
The ratio of FEV1 to FVC
Description
The ratio of FEV1 to FVC
Time Frame
At the enrollment process
Title
Mini mental test
Description
Although this test has limited specificity in terms of differentiating clinical syndromes, it is a short, useful and standardized method that can be used to determine the cognitive level globally. It consists of eleven items grouped under five main headings: orientation, attention and calculation, memory, and language. The test is evaluated over a total score of 30. The total score is obtained by summing the points the patient obtains from each item. The cut-off score for mild and moderate dementia in our country is calculated as 23.
Time Frame
At the enrollment process
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alp Özel, MSc
Organizational Affiliation
BAIBU, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eylem Tütün Yümin, PhD
Organizational Affiliation
BAIBU, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suat Konuk, MD
Organizational Affiliation
BAIBU, Faculty of Medicine, Department of Chest Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bolu Abant Izzet Baysal University, Faculty of Health Sciences, Physiotherapy and rehabilitation department
City
Bolu
ZIP/Postal Code
14030
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of Square Step Exercise Applied by Telerehabilitation in Chronic Obstructive Pulmonary Disease Patients
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