The Effectiveness Pulmonary Telerehabilitation and Cognitive Telerehabilitation in COPD Patients

NCT ID: NCT05222295

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-02-24

Brief Summary

The aim of our study is to compare the effectiveness of the supervized pulmonary telerehabilitation program and the cognitive telerehabilitation method, which includes pulmonary telerehabilitation methods, in patients with severe stage COPD who have difficulty exercising heavily. The effects of pulmonary and cognitive rehabilitation on dyspnea, muscle strength, functional capacity, quality of life, anxiety and depression levels in this patient group will be examined.

The number of studies in the literature in which the pulmonary rehabilitation program was applied as telerehabilitation is insufficient. Considering that this patient group is not motivated and has difficulty in exercising, motor imagery and movement observation methods from cognitive rehabilitation methods may be alternative methods for these patients. Although these methods have been very popular in recent years in terms of researching and demonstrating their effectiveness in various patient groups in the literature, no study has been found in which the effects of these methods have been applied in pulmonary disease groups. This study aims to contribute to the serious gap in the literature on the application of pulmonary telerehabilitation and its effectiveness, and to be an original study by investigating the effectiveness of motor imagery and action observation, which are popular rehabilitation methods of recent years, in COPD patients in the pulmonary disease group for the first time.

Detailed Description

The demographic information of the participants who accepted to participate in the study by reading and signing the voluntary consent form will be questioned with the demographic data form to be created by the researchers. The patients' dyspnea status will be evaluated with the Modified Medical Research Council Dyspnea Scale, and their exercise capacity will be evaluated with the 6-minute walk test (6 MWT). Modified Borg Scale will be used to determine dyspnea and leg fatigue before and after 6MWT, and a digital sphygmomanometer will be used to measure blood pressure. Before, during and after the test, saturation and heart rate will be determined by finger pulse oximetry. Blood lactate levels will be determined with a portable lactate meter. An electronic hand dynamometer will be used to measure peripheral muscle strength. Activities of daily living will be assessed with the London Chest Activity of Daily Living Scale. Quality of life will be determined by The Saint George Respiratory Questionnaire, and anxiety and depression status will be determined by the Hospital Anxiety and Depression Scale. Muscle activities will be analyzed using a surface electromyographic (EMG) measuring device. The mental imagery abilities of the patients will be evaluated with the Kinesthetic and Visual Imagery Questionnaire-20 and the mental chronometry method.

Evaluations will be made by the responsible physiotherapist at the hospital before the program, at the end of the 4th week and at the end of the 8th week of the program. The permissions for the use of the questionnaires to be used were obtained from the authors, who made the validity and reliability in Turkish, via e-mail. Ethical approval of the study was obtained from the Ethics Committee of Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital.

Conditions

Severe Chronic Obstructive Pulmonary Disease; Dyspnea; Muscle Weakness; Fatigue; Quality of Life; Muscle Strength; Motor Imagery; Functional Capacity; Muscle; Accessory; Respiratory Disease; Pulmonary Disease; COPD

Study Design

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

Study Groups

Supervised Pulmonary Telerehabilitation Group

Three times a week for 8 weeks, a supervised and standardized pulmonary rehabilitation program will be applied in the form of telerehabilitation with simultaneous video conference method, accompanied by a specialist physiotherapist, while the patients are at home.

Group Type: EXPERIMENTAL

Supervised Pulmonary Telerehabilitation

Intervention Type: OTHER

For pulmonary rehabilitation to be applied in the simultaneous telerehabilitation method, digital blood pressure measurement device, digital finger pulse oximeter device will be given to severe COPD patients for safe exercise and they will be informed about confidence intervals and how to use saturation and heart rate monitors. The relevant program and points to be considered will be delivered to the patients in the form of an online PDF brochure.

Cognitive Telerehabilitation Group

Motor imagery + action observation methods will be applied. In therapy, a video recording of each exercise in the supervised telerehabilitation group will be sent to the patients by the physiotherapist in accordance with the number of repetitions. At the end of the session, the cognitive telerehabilitation group will be asked to actively do the breathing exercises and active breathing techniques cycle in the supervised telerehabilitation group as well as to imagine with the instructions in the video recording, and commands will be given accordingly.

Group Type: EXPERIMENTAL

Cognitive Telerehabilitation

Intervention Type: OTHER

These patients will be asked to do a standardized pulmonary telerehabilitation program three times a week for 8 weeks by watching videos consisting of commands and exercise videos transmitted to them, some of them by actively doing, imagining.

Interventions

Supervised Pulmonary Telerehabilitation

For pulmonary rehabilitation to be applied in the simultaneous telerehabilitation method, digital blood pressure measurement device, digital finger pulse oximeter device will be given to severe COPD patients for safe exercise and they will be informed about confidence intervals and how to use saturation and heart rate monitors. The relevant program and points to be considered will be delivered to the patients in the form of an online PDF brochure.

Intervention Type: OTHER

Cognitive Telerehabilitation

These patients will be asked to do a standardized pulmonary telerehabilitation program three times a week for 8 weeks by watching videos consisting of commands and exercise videos transmitted to them, some of them by actively doing, imagining.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Volunteering to participate in the study
• Being diagnosed with C and D group COPD according to GOLD (Global iniative for chronic Obstructive Lung Disease) staging
• Not using an assistive device
• Using the same drugs for the last 4 weeks
• Permission to participate in the exercise for the patient from the responsible physician
• Getting a score of 24 or higher in the Standardized Mini Mental State Examination (MMDM)
• Absence of additional comorbid diseases of the orthopedic, neurological, cardiac system
• Having a score of 30 or higher on each of the Kinesthetic and Visual Imagery Questionnaire -20 (KGIA-20) visual imagery score and kinesthetic imagery score

Exclusion Criteria

• Refusing to participate in the study
• Presence of respiratory system disease other than COPD
• Contraindication for moderate-intensity exercise (eg, unstable heart disease or stage 2 hypertension)
• Being an active smoker
• Patients who have had an acute exacerbation of COPD in the last 4 weeks
• Patients who have used oral corticosteroid drugs in the last 4 weeks
• Internet, computer, etc. patients who do not have technological equipment
• Patients who had a COPD exacerbation during the study protocol
• Participants who cannot understand verbal instructions and are visually impaired
• Having participated in another clinical trial within the last 30 days and currently that could affect the results of the trial.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Amine Ataç

MSc Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Hansen H, Bieler T, Beyer N, Godtfredsen N, Kallemose T, Frolich A. COPD online-rehabilitation versus conventional COPD rehabilitation - rationale and design for a multicenter randomized controlled trial study protocol (CORe trial). BMC Pulm Med. 2017 Nov 16;17(1):140. doi: 10.1186/s12890-017-0488-1.

Reference Type: BACKGROUND

PMID: 29145831 (View on PubMed)

Blampain J, Ott L, Delevoye-Turrell YN. Seeing action simulation as it unfolds: The implicit effects of action scenes on muscle contraction evidenced through the use of a grip-force sensor. Neuropsychologia. 2018 Jun;114:231-242. doi: 10.1016/j.neuropsychologia.2018.04.026. Epub 2018 Apr 27.

Reference Type: BACKGROUND

PMID: 29709583 (View on PubMed)

Other Identifiers

PulmoCogniRehab

Identifier Type: -

Identifier Source: org_study_id