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
Verified date | April 2023 |
Source | Saglik Bilimleri Universitesi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Yedikule Chest Disease Hospital | Istanbul | Zeytinburnu |
Lead Sponsor | Collaborator |
---|---|
Saglik Bilimleri Universitesi |
Turkey,
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
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 |
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