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The Effectiveness Pulmonary Telerehabilitation and Cognitive Telerehabilitation in COPD Patients

Primary Purpose

Severe Chronic Obstructive Pulmonary Disease, Dyspnea, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Supervised Pulmonary Telerehabilitation
Cognitive Telerehabilitation
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Chronic Obstructive Pulmonary Disease focused on measuring 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

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yedikule Chest Disease Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Supervised Pulmonary Telerehabilitation Group

Cognitive Telerehabilitation Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Respiratory muscle activity
Main and accessory respiratory muscle activity will be analyzed using an electromyographic (EMG) measuring device.
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).
Mental chronometry method
Patients' mental imagery abilities will be assessed with mental chronometry method.
Blood Lactate Measurement
Measurement will be made from the middle finger with a portable blood lactate meter.
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.
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.
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.

Full Information

First Posted
January 22, 2022
Last Updated
April 10, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05222295
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
February 24, 2023 (Actual)
Study Completion Date
February 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized prospective clinical trial
Masking
Participant
Masking Description
Each patient will be interviewed and evaluated alone, and it will be ensured that they do not coincide with other patients who may be included in the study.
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised Pulmonary Telerehabilitation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Telerehabilitation Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Supervised Pulmonary Telerehabilitation
Intervention Description
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
Intervention Name(s)
Cognitive Telerehabilitation
Intervention Description
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 Outcome Measure Information:
Title
The exercise capacity
Description
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.
Time Frame
Change from baseline functional capacity at 8 weeks
Title
Perception of dyspnea
Description
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.
Time Frame
Change from baseline dyspnea level at 8 weeks
Title
Peripheral muscle strength
Description
An electronic hand dynamometer will be used to measure peripheral muscle strength.
Time Frame
Change from baseline peripheral muscle strength at 8 weeks
Secondary Outcome Measure Information:
Title
Respiratory muscle activity
Description
Main and accessory respiratory muscle activity will be analyzed using an electromyographic (EMG) measuring device.
Time Frame
Change from baseline accessory respiratory muscle activity at 8 weeks
Title
Kinesthetic and Visual Imagery Questionnaire-20
Description
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).
Time Frame
Change from baseline imagery abilities level at 8 weeks
Title
Mental chronometry method
Description
Patients' mental imagery abilities will be assessed with mental chronometry method.
Time Frame
Change from baseline imagery abilities between real time and imagery time level at 8 weeks
Title
Blood Lactate Measurement
Description
Measurement will be made from the middle finger with a portable blood lactate meter.
Time Frame
Change from baseline blood lactate level at 8 weeks
Title
the London Chest Activity of Daily Living Scale
Description
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.
Time Frame
Change from baseline activities of daily living at 8 weeks
Title
The Saint George Respiratory Questionnaire (SGRQ)
Description
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.
Time Frame
Change from baseline quality of life at 8 weeks
Title
the Hospital Anxiety and Depression Scale
Description
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.
Time Frame
Change from baseline anxiety and depression status at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Yedikule Chest Disease Hospital
City
Istanbul
State/Province
Zeytinburnu
ZIP/Postal Code
34200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29145831
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.
Results Reference
background
PubMed Identifier
29709583
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.
Results Reference
background

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The Effectiveness Pulmonary Telerehabilitation and Cognitive Telerehabilitation in COPD Patients

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