The Effectiveness Pulmonary Telerehabilitation and Cognitive Telerehabilitation in COPD Patients

Quality of Life Clinical Trial

Official title:

Comparison of the Effectiveness of Supervized Home-Based Pulmonary Telerehabilitation Program and Cognitive Telerehabilitation in Patients With Severe Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05222295
• Other study ID #: PulmoCogniRehab
• Status: Completed
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: February 24, 2023

Study information

• Verified date: April 2023
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 24, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Dyspnea
• Fatigue
• Functional Capacity
• Lung Diseases
• Lung Diseases, Obstructive
• Motor Imagery
• Muscle Strength
• Muscle Weakness
• Paresis
• Pulmonary Disease
• Pulmonary Disease, Chronic Obstructive
• Quality of Life
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Severe Chronic Obstructive Pulmonary Disease

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Yedikule Chest Disease Hospital	Istanbul	Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The exercise capacity	The exercise capacity will be evaluate by the 6 minute walking test (6MWT).The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines.	Change from baseline functional capacity at 8 weeks
Primary	Perception of dyspnea	The patients' dyspnea status will be evaluated with the Modified Medical Research Council Dyspnea Scale (mMRC Dyspnea Scale). he severity of dyspnea is rated on a scale of 0 to 4. "0" means no dyspnea perception, "4" means severe dyspnea perception.	Change from baseline dyspnea level at 8 weeks
Primary	Peripheral muscle strength	An electronic hand dynamometer will be used to measure peripheral muscle strength.	Change from baseline peripheral muscle strength at 8 weeks
Secondary	Respiratory muscle activity	Main and accessory respiratory muscle activity will be analyzed using an electromyographic (EMG) measuring device.	Change from baseline accessory respiratory muscle activity at 8 weeks
Secondary	Kinesthetic and Visual Imagery Questionnaire-20	Patients' mental imagery abilities will be assessed with the Kinesthetic and Visual Imagery Questionnaire-20. With the questionnaire, the intensity level of the imagery is recorded on a 5-point Likert scale (Visual imagery; 5= As clear as the original, 4: Quite clear, 3= Medium sharp, 2= Blurred, 1= No image) (Kinesthetic imagery; 5= As intense as if you were doing the movement) , 4 = Fairly intense, 3 = Moderately intense, 2 = Slightly intense, 1 = no sensation).	Change from baseline imagery abilities level at 8 weeks
Secondary	Mental chronometry method	Patients' mental imagery abilities will be assessed with mental chronometry method.	Change from baseline imagery abilities between real time and imagery time level at 8 weeks
Secondary	Blood Lactate Measurement	Measurement will be made from the middle finger with a portable blood lactate meter.	Change from baseline blood lactate level at 8 weeks
Secondary	the London Chest Activity of Daily Living Scale	Activities of daily living (ADL) will be assessed with the London Chest Activity of Daily Living Scale. Each item is scored from 0 to 5, and higher scores indicate greater difficulty in performing the ADL.	Change from baseline activities of daily living at 8 weeks
Secondary	The Saint George Respiratory Questionnaire (SGRQ)	Quality of life will be determined by The Saint George Respiratory Questionnaire. Scores range from 0-100. A score of zero indicates normal and a score of 100 indicates maximum disability. In the SGRQ questionnaire, four units of treatment-related change are considered significant.	Change from baseline quality of life at 8 weeks
Secondary	the Hospital Anxiety and Depression Scale	Anxiety and depression status will be determined by the Hospital Anxiety and Depression Scale. The items in the scale are evaluated with a 4-point Likert scale and are based on a scoring system between 0-3. According to the scoring, 0-1 is considered as non-patient, 2 as borderline patients, and 2-3 as severely ill.	Change from baseline anxiety and depression status at 8 weeks