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Effect of Physical Therapy Exercises on Cardiorespiratory Fitness Level in COVID19 Patients After Recovery.

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Physical Exercises
Sponsored by
Government College University Faisalabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Cardiorespiratory fitness

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Recovered from COVID 19 disease (PCR report).
  • Sub-normal performance as compared to normative data.
  • Do not have any Respiratory Problem.
  • Consent to participate in the study.
  • Able to understand and perform the exercise.
  • Age from 18 to 75.
  • Dyspnea due to COVID19.
  • Modified Borg Dyspnea Scale score at least 2 but less than 7.

Exclusion Criteria:

  • Not suffered from COVID 19.
  • Respiratory Problem.
  • Resting Blood Pressure greater than 160/100 instead of taking medicine
  • Greater than 1-month post COVID19 Recovery.
  • Cardiorespiratory comorbidities which limit participation in exercise.
  • Any Musculoskeletal problem which limit participation in Training.
  • Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal blood pressure responses or ST-segment depression > 2mm, symptomatic aortic stenosis, complex arrhythmias).
  • Unstable angina
  • Orthostatic blood pressure decrease of >20 mmHg with symptoms
  • Hypertropic cardiomyopathy

Sites / Locations

  • Bin Inam Rehabilitation Center.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Group (Ventilatory)

Intervention (Non ventilatory)

Arm Description

Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week.

Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week.

Outcomes

Primary Outcome Measures

6 minute walk test
To measure the cardio-respiratory fitness.
Modified Borg Dyspnea Scale
It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.

Secondary Outcome Measures

SF-36 QUESTIONNAIRE
The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better HRQOL

Full Information

First Posted
June 22, 2020
Last Updated
October 6, 2020
Sponsor
Government College University Faisalabad
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1. Study Identification

Unique Protocol Identification Number
NCT04445376
Brief Title
Effect of Physical Therapy Exercises on Cardiorespiratory Fitness Level in COVID19 Patients After Recovery.
Official Title
Effect of Aerobic Exercises on Cardio-respiratory Fitness and Quality of Life in Recovered COVID 19 Recovered Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
September 10, 2020 (Actual)
Study Completion Date
October 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government College University Faisalabad

4. Oversight

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

5. Study Description

Brief Summary
In some patients, lung function declined by about 20 to 30% after recovery. Computer tomography of COVID-19 patients revealed a ground glass opacity in both lungs. We will measure the Cardiorespiratory fitness according to American College of Sports medicine guidline and provide physiotherapy exercise to the patients to measure the improvement.
Detailed Description
In December 2019, the first reports emerged of a novel severe acute respiratory syndrome (SARS) coronavirus 2 (SARS-CoV-2) in Wuhan, China. The virus, which causes atypical pneumonia progressing to acute lung injury and acute respiratory distress syndrome (ARDS) in some individuals, was named COVID-19. The burden of fibrotic lung disease following SARS-CoV-2 infection is likely to be high; therefore, given the scale of the pandemic, the global burden of fibrotic lung disease will probably increase considerably. The aim of this study is to check the cardiorespiratory fitness level and the effect of Physical therapy intervention to improve the Cardiorespiratory fitness level in patients recovered from COVID-19. Quality of life has also been affected due to COVID19 due to decreased Cardiorespiratory fitness level, and this study also aims to improve the quality of life of people recovered from COVID19.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Cardiorespiratory fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group (Ventilatory)
Arm Type
Experimental
Arm Description
Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week.
Arm Title
Intervention (Non ventilatory)
Arm Type
Experimental
Arm Description
Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week.
Intervention Type
Other
Intervention Name(s)
Physical Exercises
Intervention Description
Aerobic Training and Breathing Exercises.
Primary Outcome Measure Information:
Title
6 minute walk test
Description
To measure the cardio-respiratory fitness.
Time Frame
5 weeks
Title
Modified Borg Dyspnea Scale
Description
It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
SF-36 QUESTIONNAIRE
Description
The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better HRQOL
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recovered from COVID 19 disease (PCR report). Sub-normal performance as compared to normative data. Do not have any Respiratory Problem. Consent to participate in the study. Able to understand and perform the exercise. Age from 18 to 75. Dyspnea due to COVID19. Modified Borg Dyspnea Scale score at least 2 but less than 7. Exclusion Criteria: Not suffered from COVID 19. Respiratory Problem. Resting Blood Pressure greater than 160/100 instead of taking medicine Greater than 1-month post COVID19 Recovery. Cardiorespiratory comorbidities which limit participation in exercise. Any Musculoskeletal problem which limit participation in Training. Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal blood pressure responses or ST-segment depression > 2mm, symptomatic aortic stenosis, complex arrhythmias). Unstable angina Orthostatic blood pressure decrease of >20 mmHg with symptoms Hypertropic cardiomyopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ishtiaq Ahmed, DPT
Organizational Affiliation
Government College University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bin Inam Rehabilitation Center.
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32422178
Citation
George PM, Wells AU, Jenkins RG. Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy. Lancet Respir Med. 2020 Aug;8(8):807-815. doi: 10.1016/S2213-2600(20)30225-3. Epub 2020 May 15.
Results Reference
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PubMed Identifier
32764112
Citation
Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4):2002096. doi: 10.1183/13993003.02096-2020. Print 2020 Oct.
Results Reference
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Effect of Physical Therapy Exercises on Cardiorespiratory Fitness Level in COVID19 Patients After Recovery.

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