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Completed

NCT Number: NCT05222295

The Effectiveness Pulmonary Telerehabilitation and Cognitive Telerehabilitation in COPD Patients

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.

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Key information

Conditions

Severe Chronic Obstructive Pulmonary Disease COPD Chronic Disease Disease Attributes Dyspnea Fatigue Functional Capacity Lung Diseases Lung Diseases, Obstructive Motor Imagery Muscle Strength Muscle Weakness Muscle; Accessory Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease Pulmonary Disease, Chronic Obstructive Quality of Life Respiration Disorders Respiratory Disease Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised Pulmonary Telerehabilitation

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

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.

Primary outcomes

  1. The exercise capacity

    Time frame: Change from baseline functional capacity at 8 weeks

    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.

  2. Perception of dyspnea

    Time frame: Change from baseline dyspnea level at 8 weeks

    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.

  3. Peripheral muscle strength

    Time frame: Change from baseline peripheral muscle strength at 8 weeks

    An electronic hand dynamometer will be used to measure peripheral muscle strength.

Secondary outcomes

  1. Respiratory muscle activity

    Time frame: Change from baseline accessory respiratory muscle activity at 8 weeks

    Main and accessory respiratory muscle activity will be analyzed using an electromyographic (EMG) measuring device.

  2. Kinesthetic and Visual Imagery Questionnaire-20

    Time frame: Change from baseline imagery abilities level at 8 weeks

    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).

  3. Mental chronometry method

    Time frame: Change from baseline imagery abilities between real time and imagery time level at 8 weeks

    Patients' mental imagery abilities will be assessed with mental chronometry method.

  4. Blood Lactate Measurement

    Time frame: Change from baseline blood lactate level at 8 weeks

    Measurement will be made from the middle finger with a portable blood lactate meter.

  5. the London Chest Activity of Daily Living Scale

    Time frame: Change from baseline activities of daily living at 8 weeks

    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.

  6. The Saint George Respiratory Questionnaire (SGRQ)

    Time frame: Change from baseline quality of life at 8 weeks

    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.

  7. the Hospital Anxiety and Depression Scale

    Time frame: Change from baseline anxiety and depression status at 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2022
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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