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Comparison of Pulmonary Telerehabilitation and Physical Activity Recommendations in Patients With Post Covid Fibrosis

Primary Purpose

COVID-19, Pulmonary Fibrosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Post covid fibrosis, Pulmonary Rehabilitation, Physical Activity

Eligibility Criteria

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

Inclusion Criteria:

  • >18 years old
  • Patients who have been infected with the COVID-19 virus at least three months ago and have been diagnosed with a positive PCR
  • Patients with post-COVID-19 pulmonary fibrosis followed by a pulmonologist
  • Patients who have sufficient technological infrastructure to participate in the telerehabilitation program and can adapt to online systems
  • Patients who are clinically stable

Exclusion Criteria:

  • Patients with orthopedic/neurological problems that prevent walking and exercise
  • Patients with uncontrolled cardiovascular disease
  • Patients with uncontrolled medical conditions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pulmonary Rehabilitation Group

    Physical Activity Group

    Arm Description

    A total of 24 sessions of breathing exercises and high-repetitive muscle endurance and strengthening exercises will be applied to the pulmonary telerehabilitation group for 8 weeks, two days a week and one day a week unsupervised, via online systems. High-repetition muscle endurance and strengthening exercises will be applied to large muscle groups of the lower and upper extremities by creating resistance with body weight and theraband.

    Respiratory exercises and physical activity recommendations will be given to the physical activity group. Physical activity recommendations are; It will include information about the importance of physical activity and walking 3-5 days a week for at least 30 minutes of moderate intensity (4-6 on the Modified Borg scale of perceived exertion level).

    Outcomes

    Primary Outcome Measures

    Exercise capacity
    Six minute walk test and
    Exercise capacity
    Shuttle walk tests
    Peripheral muscle strength
    Hand-held dynamometer

    Secondary Outcome Measures

    Physical activity
    Pedometer and activity monitor
    Symptoms
    Modified Medical Research Council Dyspnea Scale stratifies severity of dyspnea in respiratory diseases
    Symptoms
    Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue. FSS contains nine statements that rate the severity of your fatigue symptoms. A low value indicates strong disagreement with the statement, whereas a high value indicates strong agreement.
    Physical fitness
    1 min sit to stand test
    Functionality
    Post covid-19 functionality scale (PCFS): The PCFS scale stratifies functional status limitation as follows: grade 0 (No functional limitations), grade 1 (Negligible functional limitations), grade 2 (Slight functional limitations), grade 3 (Moderate functional limitations), grade 4 (Severe functional limitations), and grade 5 (death)

    Full Information

    First Posted
    March 25, 2022
    Last Updated
    March 28, 2022
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05299333
    Brief Title
    Comparison of Pulmonary Telerehabilitation and Physical Activity Recommendations in Patients With Post Covid Fibrosis
    Official Title
    Comparison of the Effectiveness of Pulmonary Telerehabilitation and Physical Activity Recommendations in Patients With Pulmonary Fibrosis Due to COVID-19
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 4, 2022 (Anticipated)
    Primary Completion Date
    June 7, 2024 (Anticipated)
    Study Completion Date
    June 7, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University - Cerrahpasa (IUC)

    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
    Rehabilitation plays a very important role in the management of patients with COVID-19, focusing on respiratory and motor functions, and therefore the importance of establishing treatment strategies to ensure optimal recovery of these patients has been emphasized. It has been stated that physical activity recommendations should be clarified for the management of symptoms associated with prolonged COVID-19 Syndrome and for the continuation of activities of daily living. It has been stated that after COVID-19 pneumonia, it is necessary to evaluate the physical functions of patients with long-term follow-up and to establish rehabilitation programs. The importance of being included in the rehabilitation program was emphasized, especially for patients with lung fibrosis. The primary aim of this study was to compare the effects of pulmonary telerehabilitation and physical activity recommendations on exercise capacity and peripheral muscle strength in patients with pulmonary fibrosis due to COVID-19. The secondary aim of this study is to compare the effects of pulmonary telerehabilitation and physical activity recommendations on symptoms, activity and participation in patients with pulmonary fibrosis due to COVID-19.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19, Pulmonary Fibrosis
    Keywords
    Post covid fibrosis, Pulmonary Rehabilitation, Physical Activity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pulmonary Rehabilitation Group
    Arm Type
    Experimental
    Arm Description
    A total of 24 sessions of breathing exercises and high-repetitive muscle endurance and strengthening exercises will be applied to the pulmonary telerehabilitation group for 8 weeks, two days a week and one day a week unsupervised, via online systems. High-repetition muscle endurance and strengthening exercises will be applied to large muscle groups of the lower and upper extremities by creating resistance with body weight and theraband.
    Arm Title
    Physical Activity Group
    Arm Type
    Active Comparator
    Arm Description
    Respiratory exercises and physical activity recommendations will be given to the physical activity group. Physical activity recommendations are; It will include information about the importance of physical activity and walking 3-5 days a week for at least 30 minutes of moderate intensity (4-6 on the Modified Borg scale of perceived exertion level).
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    High repetition muscle endurance and strengthening exercises Walking
    Primary Outcome Measure Information:
    Title
    Exercise capacity
    Description
    Six minute walk test and
    Time Frame
    1 week-8 week
    Title
    Exercise capacity
    Description
    Shuttle walk tests
    Time Frame
    1 week-8 week
    Title
    Peripheral muscle strength
    Description
    Hand-held dynamometer
    Time Frame
    1 week-8 week
    Secondary Outcome Measure Information:
    Title
    Physical activity
    Description
    Pedometer and activity monitor
    Time Frame
    1 week-8 week
    Title
    Symptoms
    Description
    Modified Medical Research Council Dyspnea Scale stratifies severity of dyspnea in respiratory diseases
    Time Frame
    1 week-8 week
    Title
    Symptoms
    Description
    Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue. FSS contains nine statements that rate the severity of your fatigue symptoms. A low value indicates strong disagreement with the statement, whereas a high value indicates strong agreement.
    Time Frame
    1 week-8 week
    Title
    Physical fitness
    Description
    1 min sit to stand test
    Time Frame
    1 week-8 week
    Title
    Functionality
    Description
    Post covid-19 functionality scale (PCFS): The PCFS scale stratifies functional status limitation as follows: grade 0 (No functional limitations), grade 1 (Negligible functional limitations), grade 2 (Slight functional limitations), grade 3 (Moderate functional limitations), grade 4 (Severe functional limitations), and grade 5 (death)
    Time Frame
    1 week-8 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: >18 years old Patients who have been infected with the COVID-19 virus at least three months ago and have been diagnosed with a positive PCR Patients with post-COVID-19 pulmonary fibrosis followed by a pulmonologist Patients who have sufficient technological infrastructure to participate in the telerehabilitation program and can adapt to online systems Patients who are clinically stable Exclusion Criteria: Patients with orthopedic/neurological problems that prevent walking and exercise Patients with uncontrolled cardiovascular disease Patients with uncontrolled medical conditions

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Pulmonary Telerehabilitation and Physical Activity Recommendations in Patients With Post Covid Fibrosis

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