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

NCT ID: NCT04841005

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2022-02-15

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.

Conditions

COPD; Cognitive Impairment; Balance; Distorted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Square-Step Exercise group

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

Group Type: EXPERIMENTAL

The Square-Step Exercise Training

Intervention Type: 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.

Strengthening Exercise Group

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

Group Type: EXPERIMENTAL

Strengthening Exercise Training

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Alp Ozel

MSc,Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alp Özel, MSc

Role: PRINCIPAL_INVESTIGATOR

BAIBU, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

Eylem Tütün Yümin, PhD

Role: PRINCIPAL_INVESTIGATOR

BAIBU, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

Suat Konuk, MD

Role: PRINCIPAL_INVESTIGATOR

BAIBU, Faculty of Medicine, Department of Chest Diseases

Locations

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

Bolu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AIBU-FTR-AO-01

Identifier Type: -

Identifier Source: org_study_id