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

NCT04841005 | Completed

• 1 other identifier: AIBU-FTR-AO-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Cognitive Impairment; Balance; Distorted

Outcome Measures

Primary Outcomes (5)

• 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.

  Two measurements: At the beginning and after eight weeks

• 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.

  Two measurements: At the beginning and after eight weeks

• 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.

  Two measurements: At the beginning and after eight weeks

• 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.

  Two measurements: At the beginning and after eight weeks

• 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.

  At the enrollment process

Secondary Outcomes (8)

• Assessment of the COPD

  At the enrollment process

• Assessment of comorbidities

  At the enrollment process

• Evaluation of shortness of breath

  At the enrollment process

• 1 Minute Sit and Stand Test

  Two measurements: At the beginning and after eight weeks

• Forced expiratory volume in the first second

  At the enrollment process

Study Arms (2)

Square-Step Exercise group

EXPERIMENTAL

Square-step exercise for 8 weeks will be applied under the supervision of a physiotherapist.

Other: The Square-Step Exercise Training

Strengthening Exercise Group

EXPERIMENTAL

Strengthening exercise for 8 weeks will be applied under the supervision of a physiotherapist.

Other: Strengthening Exercise Training

Interventions

The Square-Step Exercise Training OTHER

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.

Square-Step Exercise group

Strengthening Exercise Training OTHER

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.

Strengthening Exercise Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University, Faculty of Health Sciences, Physiotherapy and rehabilitation department

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc,Research assistant

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 12, 2021
• Study Start: April 6, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)