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Investigation of Square Step Exercise Applied by Telerehabilitation in Chronic Obstructive Pulmonary Disease Patients (COPD)

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ClinicalTrials.gov Identifier: NCT04841005
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Alp Ozel, Abant Izzet Baysal University

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.

Condition or disease Intervention/treatment Phase
COPD Cognitive Impairment Balance; Distorted Other: The Square-Step Exercise Training Other: Strengthening Exercise Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Investigation of the Effect of Square-Step Exercise Applied by Telerehabilitation on Cognitive Functions, Balance and Quality of Life in COPD Patients
Actual Study Start Date : April 6, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Square-Step Exercise group
Square-step exercise for 8 weeks will be applied under the supervision of a physiotherapist.
Other: The Square-Step Exercise Training
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.

Experimental: Strengthening Exercise Group
Strengthening exercise for 8 weeks will be applied under the supervision of a physiotherapist.
Other: Strengthening Exercise Training
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 Measures :
  1. Change of the point in the cognitive test [ Time Frame: Two measurements: At the beginning and after eight weeks ]
    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.

  2. Measurement of change in postural stability [ Time Frame: Two measurements: At the beginning and after eight weeks ]
    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.

  3. Measurement of change in functional balance [ Time Frame: Two measurements: At the beginning and after eight weeks ]
    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.

  4. Measuring change in quality of life [ Time Frame: Two measurements: At the beginning and after eight weeks ]
    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.

  5. Hospital Anxiety and Depression Scale [ Time Frame: Two measurements: At the beginning and after eight weeks ]
    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 :
  1. Assessment of the COPD [ Time Frame: Time Frame: At the enrollment process ]
    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.

  2. Assessment of comorbidities [ Time Frame: Time Frame: At the enrollment process ]
    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.

  3. Evaluation of shortness of breath [ Time Frame: Time Frame: At the enrollment process ]
    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

  4. 1 Minute Sit and Stand Test [ Time Frame: Time Frame: At the enrollment process ]
    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.

  5. Forced expiratory volume in the first second [ Time Frame: Time Frame: At the enrollment process ]
    Forced expiratory volume in the first second (FEV1)

  6. Forced vital capacity [ Time Frame: Time Frame: At the enrollment process ]
    Forced vital capacity (FVC)

  7. The ratio of FEV1 to FVC [ Time Frame: Time Frame: At the enrollment process ]
    The ratio of FEV1 to FVC

  8. Mini mental test [ Time Frame: Two measurements: At the beginning and after eight weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841005


Contacts
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Contact: Alp Özel, MSc +903742541000 ext 4135 ptalpozel@gmail.com
Contact: Eylem Tütün Yümin, PhD +903742541000 ext 4111 tutun_e@ibu.edu.tr

Locations
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Turkey
Bolu Abant Izzet Baysal University, Faculty of Health Sciences, Physiotherapy and rehabilitation department Recruiting
Bolu, Turkey, 14030
Contact: Alp Özel, MSc    +903742541010 ext 4135    ptalpozel@gmail.com   
Contact: Eylme Tütün Yümin, PhD    +903742541010 ext 4111    tutun_e@ibu.edu.tr   
Principal Investigator: Alp Özel, MSc         
Principal Investigator: Eylem Tütün Yümin, PhD         
Principal Investigator: Suat Konuk, MD         
Sponsors and Collaborators
Abant Izzet Baysal University
Investigators
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Principal Investigator: Alp Özel, MSc BAIBU, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Principal Investigator: Eylem Tütün Yümin, PhD BAIBU, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Principal Investigator: Suat Konuk, MD BAIBU, Faculty of Medicine, Department of Chest Diseases
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Responsible Party: Alp Ozel, MSc,Research assistant, Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT04841005    
Other Study ID Numbers: AIBU-FTR-AO-01
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders