Clinical trial NCT05222295: The Effectiveness Pulmonary Telerehabilitation and Cognitive Telerehabilitation in COPD Patients
Official title: Comparison of the Effectiveness of Supervized Home-Based Pulmonary Telerehabilitation Program and Cognitive Telerehabilitation in Patients With Severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Keywords: severe COPD
Severe Chronic Obstructive Pulmonary Disease
Pulmonary Telerehabilitation
Cognitive Telerehabilitation
Motor Imagery
Action Observation
Dyspnea
Muscle Strength
Blood Lactate Level
Daily Living Activities
Quality of Life
Muscle Weakness
Functional Capacity
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The exercise capacity
timeFrame: Change from baseline functional capacity at 8 weeks
measure: Perception of dyspnea
timeFrame: Change from baseline dyspnea level at 8 weeks
measure: Peripheral muscle strength
timeFrame: Change from baseline peripheral muscle strength at 8 weeks
Secondary outcomes:
measure: Respiratory muscle activity
timeFrame: Change from baseline accessory respiratory muscle activity at 8 weeks
measure: Kinesthetic and Visual Imagery Questionnaire-20
timeFrame: Change from baseline imagery abilities level at 8 weeks
measure: Mental chronometry method
timeFrame: Change from baseline imagery abilities between real time and imagery time level at 8 weeks
measure: Blood Lactate Measurement
timeFrame: Change from baseline blood lactate level at 8 weeks
measure: the London Chest Activity of Daily Living Scale
timeFrame: Change from baseline activities of daily living at 8 weeks
measure: The Saint George Respiratory Questionnaire (SGRQ)
timeFrame: Change from baseline quality of life at 8 weeks
measure: the Hospital Anxiety and Depression Scale
timeFrame: Change from baseline anxiety and depression status at 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yedikule Chest Disease Hospital
state: Zeytinburnu
Study officials:
References:
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.
citation: 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.