The Effectiveness Pulmonary Telerehabilitation and Cognitive Telerehabilitation in COPD Patients

NCT05222295 | Completed

• 1 other identifier: PulmoCogniRehab
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• Respiratory muscle activity

  Change from baseline accessory respiratory muscle activity at 8 weeks

• Kinesthetic and Visual Imagery Questionnaire-20

  Change from baseline imagery abilities level at 8 weeks

• Mental chronometry method

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

• Blood Lactate Measurement

  Change from baseline blood lactate level at 8 weeks

• the London Chest Activity of Daily Living Scale

  Change from baseline activities of daily living at 8 weeks

Study Arms (2)

Supervised Pulmonary Telerehabilitation Group

EXPERIMENTAL

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.

Other: Supervised Pulmonary Telerehabilitation

Cognitive Telerehabilitation Group

EXPERIMENTAL

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.

Other: Cognitive Telerehabilitation

Interventions

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.

Supervised Pulmonary Telerehabilitation Group

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.

Cognitive Telerehabilitation Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 29145831 BACKGROUND

• 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.

  PMID: 29709583 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Muscle Weakness; Fatigue; Respiration Disorders; Lung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Physiotherapist

Model Details: Randomized prospective clinical trial

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 3, 2022
• Study Start: January 31, 2022
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

TU (1)