Effect of Respiratory Versus Aerobic Training on Respiratory and Immunity Efficiency in Recovered COVID- 19 Patients

This study will be conducted on eighty patients of both sexes with age ranging from 35 to 45years. The will be recovered from COVID-19 infection with chest symptoms. They will be selected from Nasr city police authority hospital. They will be randomly assigned into 3 equal groups.

Study Overview

• Status: Completed
• Conditions: Covid 19 Infection
• Intervention / Treatment: Other: Respiratory Training; Other: Aerobic training

Detailed Description

This study will be conducted on eighty patients of both sexes with age ranging from 35 to 45years. The will be recovered from COVID-19 infection with chest symptoms. They will be selected from Nasr city police authority hospital. They will be randomly assigned into 3 equal groups.

Participants will be assigned into 3 groups equal in number (group A, group B, group C)

Group A (Respiratory Training Group) : It will include 30 patients of both sexes, recovered from COVID-19 infection. In addition to medical drugs, they will receive respiratory training for 6 weeks.

Group B : (Aerobic Training Group) : It will include 30 patients of both sexes, recovered from COVID-19 infection. In addition to medical drugs, they will receive aerobic training for 6 weeks

Group C : (control group) :It will include 20 patients of both sexes, recovered from COVID-19 infection on medical drugs only will receive no exercise as control group.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 002
    • Police hospital-Nasr city

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients recovered from COVID -19 infection.
• Patients with body mass index 25 - 35 kg/m2
• Patients previously diagnosed with chest symptoms of COVID- 19 infection.
• Patients' body temperature less than 37.5
• Blood oxygen saturation ≥95%

Exclusion Criteria:

• Smokers
• Patients with Myocardial infarction
• Patients with diabetes.
• Patients with autoimmune disease.
• Patients with positive COVID -19 infection.
• Patients with previous chest diseases
• a heart rate of >100 bpm
• a blood pressure of <90/60 mmHg or >140/90 mmHg
• a blood oxygen saturation of ≤95%
• other diseases that are not suitable for exercise (osteoarthritis knee - stroke patients, etc)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (Respiratory Training Group); It will include 30 patients of both sexes, recovered from COVID-19 infection. In addition to medical drugs, they will receive respiratory training for 6 weeks.	Other: Respiratory Training; Respiratory training in form of : Diaphragmatic breathing,Segmental breathing, Incentive spirometer:
Active Comparator: Group B : (Aerobic Training Group); It will include 30 patients of both sexes, recovered from COVID-19 infection. In addition to medical drugs, they will receive aerobic training for 6 weeks	Other: Aerobic training; aerobic exercises are customized according to the patient's underlying disease and residual dysfunction. These exercises will include walking on treadmill. After an initial, 5-minute warm-up phase performed on the treadmill at a low load, each endurance training session lasted 30 minutes and ended with 5-minute recovery and relaxation phase. A total of 3-5 sessions are carried out per week. Patients who are prone to fatigue should perform intermittent exercises
No Intervention: Group C : (control group); It will include 20 patients of both sexes, recovered from COVID-19 infection on medical drugs only will receive no exercise as control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete blood picture	A venous blood sample will be taken to be analyzed in the laboratory	change from baseline at 6 weeks
Arterial blood gases	arterial blood sample will be assessed	change from baseline at 6 weeks
6-minute walk Distance	patient will be instructed to walk as fast as long as possible, in a 30 meters obstacle- free corridor, limited by turnaround cones. Standardized verbal encouragement will be given every minute. After 6 min, patient will be instructed to stop, and the total distance will be measured, rounding to the nearest meter.	change from baseline at 6 weeks
Breath-hold test	A rough index of cardiopulmonary reserve measured by the length of time that a person can voluntarily stop breathing; normal duration is 30 seconds or longer; diminished cardiac or pulmonary reserve is indicated by a duration of 20 seconds or less.	change from baseline at 6 weeks
Oxygen saturation	Percentage of haemoglobin saturated with oxygen measured by pulse oximeter	change from baseline at 6 weeks
Borg Dyspnea Scale score	It is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during six minute walk test	change from baseline at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum oxygen consumption	Maximum oxygen consumption(VO2 max): Results of (6MWT) was used to calculate Vo2 max by using Cahalin equation as follows; Vo2 max = 0.03x distance in meters +3.98, in which distance is obtained from (6MWT)	change from baseline at 6 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): October 24, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Estimate): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 24, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• 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: MAHA2020

Drug and device information, study documents

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