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

Effect of Aerobic Exercises on Cardio-respiratory Fitness and Quality of Life in Recovered COVID 19 Recovered Patients.

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Physical Exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalābad, Punjab, Pakistan, 38000
      • Bin Inam Rehabilitation Center.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (Ventilatory); Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week.	Other: Physical Exercises; Aerobic Training and Breathing Exercises.
Experimental: Intervention (Non ventilatory); Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week.	Other: Physical Exercises; Aerobic Training and Breathing Exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk test	To measure the cardio-respiratory fitness.	5 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Government College University Faisalabad
• Investigators: Principal Investigator: Ishtiaq Ahmed, DPT, Government College University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2020
• Primary Completion (Actual): September 10, 2020
• Study Completion (Actual): October 3, 2020

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Cardiorespiratory fitness
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No