Back to resultsEffectiveness of Pulmonary Rehabilitation Program in Patients With SARS-CoV-2 Pneumonia
Primary Purpose
Covid19, Covid19 Pneumonia, SARS-CoV 2 Pneumonia
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Pneumonia without having severe findings or a need for oxygen support therapy (mild pneumonia) accompanying special conditions (chronic lung / heart disease / diabetes / hypertension / neuromuscular disease history / elderly / immobility etc.)
- Severe pneumonia (A suspicion of fever or respiratory tract infection and having one accompanying finding: respiration rate >30/min; severe respiratory distress; or SpO2 ≤93% in ambient air.) cases after they get clinically stable (decreased fever, reduced dyspnea, respiratory rate 90%)
- At least 7 days since the diagnosis of SARS-CoV-2 in order to reduce the viral load and the risk of transmission
- Being able to make video calls for telerehabilitation
Exclusion Criteria:
- Serious cardiovascular, cerebrovascular, neuromuscular and other systemic diseases that affect physical activity
- Psychiatric illness and cognitive deficit that will affect patient's exercise cooperation
- Pregnancy
- The deterioration in the general condition of the patient, worsening of the lung findings
- Acute respiratory distress syndrome
Sites / Locations
- Sisli Hamidiye Etfal Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulmonary Rehabilitation
Arm Description
Patients are included in a personalized pulmonary telerehabilitation program consisting of patient education, respiratory and peripheral muscle training, and breathing strategies for 4 weeks. In the telerehabilitation program, exercises will be supervised by a physiotherapist two days a week, and patients will be asked to do the exercises themselves for the other 3 days. Patients will also receive instructional exercise videos for these 3 days.
Outcomes
Primary Outcome Measures
Change in Dyspnea level as measured by modified Medical Research Council (mMRC) Dyspnea Scale
The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4. 0: no breathlessness except on strenuous exercise; 4: too breathless to leave the house, or breathless when dressing or undressing.
Change in functional capacity as measured by 30-second sit-to-stand test
30 sec- STS determines lower extremity strength and physical fitness in older adults. The number of repetitions is recorded.
Secondary Outcome Measures
Change in physical activity level as measured by International Physical Activity Questionnaire (IPAQ) -Short Form
IPAQ-Short Form is used to measure level of physical activity.It consists of 7 questions that provide information about time spent on walking, moderate to vigorous physical activities, and time spent sitting. The energy required for the activities was calculated by the MET-minute/week score. Standard MET values for these activities are: Walking = 3,3 METS; Moderate Physical Activity = 4,0 METS; Vigorous Physical Activity = 8.0 METS; Sitting = 1,5 METS
Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale (HADS)
HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety.
Full Information
NCT ID
NCT04642040
First Posted
November 21, 2020
Last Updated
November 21, 2020
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04642040
Brief Title
Effectiveness of Pulmonary Rehabilitation Program in Patients With SARS-CoV-2 Pneumonia
Official Title
Effectiveness of Pulmonary Rehabilitation Program in Patients With SARS-CoV-2 Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
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 the study is to investigate the efficacy of pulmonary rehabilitation (PR) program to patients with Sars-CoV-2 pneumonia in the post-acute period on pulmonary functions, exercise capacity and anxiety level.
100 patients diagnosed with Sars-CoV-2 pneumonia will be enrolled in this prospective, interventional study according to inclusion/exclusion criteria. Patients will be evaluated and a personalized PR program will be organized before hospital discharge. After discharge, the pulmonary rehabilitation program will continue in telerehabilitation.
In the telerehabilitation program, exercises will be supervised by a physiotherapist two days a week, and patients will be asked to do the exercises themselves for the other 3 days. Patients will also receive exercise videos for these 3 days.
Patients will be followed for 4 weeks and will be called for final evaluation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Covid19 Pneumonia, SARS-CoV 2 Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
Patients are included in a personalized pulmonary telerehabilitation program consisting of patient education, respiratory and peripheral muscle training, and breathing strategies for 4 weeks. In the telerehabilitation program, exercises will be supervised by a physiotherapist two days a week, and patients will be asked to do the exercises themselves for the other 3 days. Patients will also receive instructional exercise videos for these 3 days.
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
Positioning,breathing techniques (diaphragmatic breathing, alternate breathing, and pursed-lip breathing),respiratory muscle exercises, joint ROM exercises, early-mobilization and progressive ambulation, peripheral muscle strengthening exercises
Primary Outcome Measure Information:
Title
Change in Dyspnea level as measured by modified Medical Research Council (mMRC) Dyspnea Scale
Description
The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4. 0: no breathlessness except on strenuous exercise; 4: too breathless to leave the house, or breathless when dressing or undressing.
Time Frame
4 weeks
Title
Change in functional capacity as measured by 30-second sit-to-stand test
Description
30 sec- STS determines lower extremity strength and physical fitness in older adults. The number of repetitions is recorded.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in physical activity level as measured by International Physical Activity Questionnaire (IPAQ) -Short Form
Description
IPAQ-Short Form is used to measure level of physical activity.It consists of 7 questions that provide information about time spent on walking, moderate to vigorous physical activities, and time spent sitting. The energy required for the activities was calculated by the MET-minute/week score. Standard MET values for these activities are: Walking = 3,3 METS; Moderate Physical Activity = 4,0 METS; Vigorous Physical Activity = 8.0 METS; Sitting = 1,5 METS
Time Frame
4 weeks
Title
Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale (HADS)
Description
HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pneumonia without having severe findings or a need for oxygen support therapy (mild pneumonia) accompanying special conditions (chronic lung / heart disease / diabetes / hypertension / neuromuscular disease history / elderly / immobility etc.)
Severe pneumonia (A suspicion of fever or respiratory tract infection and having one accompanying finding: respiration rate >30/min; severe respiratory distress; or SpO2 ≤93% in ambient air.) cases after they get clinically stable (decreased fever, reduced dyspnea, respiratory rate 90%)
At least 7 days since the diagnosis of SARS-CoV-2 in order to reduce the viral load and the risk of transmission
Being able to make video calls for telerehabilitation
Exclusion Criteria:
Serious cardiovascular, cerebrovascular, neuromuscular and other systemic diseases that affect physical activity
Psychiatric illness and cognitive deficit that will affect patient's exercise cooperation
Pregnancy
The deterioration in the general condition of the patient, worsening of the lung findings
Acute respiratory distress syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enes Efe Is, MD
Phone
+902123735000
Email
enefeis@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Sahillioglu, MD
Organizational Affiliation
Sisli Hamidiye Etfal Training and Research Hospital PMR Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sisli Hamidiye Etfal Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34371
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enes Efe Is, MD
Phone
+902123735000
Email
enefeis@gmail.com
First Name & Middle Initial & Last Name & Degree
Ali Sahillioglu, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32760887
Citation
Kurtais Aytur Y, Koseoglu BF, Ozyemisci Taskiran O, Ordu-Gokkaya NK, Unsal Delialioglu S, Sonel Tur B, Sarikaya S, Sirzai H, Tekdemir Tiftik T, Alemdaroglu E, Ayhan FF, Duyur Cakit BD, Genc A, Gundogdu I, Guzel R, Demirbag Karayel D, Bilir Kaya B, Oken O, Ozdemir H, Soyupek F, Tikiz C. Pulmonary rehabilitation principles in SARS-COV-2 infection (COVID-19): A guideline for the acute and subacute rehabilitation. Turk J Phys Med Rehabil. 2020 May 12;66(2):104-120. doi: 10.5606/tftrd.2020.6444. eCollection 2020 Jun.
Results Reference
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Effectiveness of Pulmonary Rehabilitation Program in Patients With SARS-CoV-2 Pneumonia
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