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

Covid 19 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04613050
• Other study ID #: MAHA2020
• Status: Completed
• Phase: N/A
• Start date: July 2, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: December 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 30, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Covid 19 Infection
• COVID-19

Intervention

Other:
• Respiratory Training
Respiratory training in form of : Diaphragmatic breathing,Segmental breathing, Incentive spirometer:
• 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

Locations

Country	Name	City	State
Egypt	Police hospital-Nasr city	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete blood picture	A venous blood sample will be taken to be analyzed in the laboratory	change from baseline at 6 weeks
Primary	Arterial blood gases	arterial blood sample will be assessed	change from baseline at 6 weeks
Primary	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
Primary	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
Primary	Oxygen saturation	Percentage of haemoglobin saturated with oxygen measured by pulse oximeter	change from baseline at 6 weeks
Primary	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	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