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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04445376
Other study ID # 313
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 3, 2020
Est. completion date October 3, 2020

Study information

Verified date October 2020
Source Government College University Faisalabad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 3, 2020
Est. primary completion date September 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical Exercises
Aerobic Training and Breathing Exercises.

Locations

Country Name City State
Pakistan Bin Inam Rehabilitation Center. Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Government College University Faisalabad

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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 the hospitalisation. Eur Respir J. 2020 Aug 6. pii: 2002096. doi: 10.1183/13993003.02096-2020. [Epub ahead of print] — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 6 minute walk test To measure the cardio-respiratory fitness. 5 weeks
Primary 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. 5 weeks
Secondary 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 5 weeks
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