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

Not Applicable

Completed

• Conditions: Covid 19 Infection
• Interventions: Other: Aerobic training; Other: Respiratory Training

• Registration Number: NCT04613050
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study Start: 2020-07-02
• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-03
• Primary Completion: 2022-10-24
• Study Completion: 2022-10-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-24
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B : (Aerobic Training Group)	Aerobic training	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 A (Respiratory Training Group)	Respiratory Training	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.

Primary Outcome Measures

Name	Time	Method
Complete blood picture	change from baseline at 6 weeks	A venous blood sample will be taken to be analyzed in the laboratory
Arterial blood gases	change from baseline at 6 weeks	arterial blood sample will be assessed
6-minute walk Distance	change from baseline at 6 weeks	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.
Breath-hold test	change from baseline at 6 weeks	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.
Oxygen saturation	change from baseline at 6 weeks	Percentage of haemoglobin saturated with oxygen measured by pulse oximeter
Borg Dyspnea Scale score	change from baseline at 6 weeks	It is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during six minute walk test

Secondary Outcome Measures

Name	Time	Method
Maximum oxygen consumption	change from baseline at 6 weeks	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)

Trial Locations

Locations (1)

Police hospital-Nasr city; 🇪🇬 Cairo, Egypt