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

Primary Purpose

Covid 19 Infection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Respiratory Training
Aerobic training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid 19 Infection

Eligibility Criteria

35 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Police hospital-Nasr city

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Group A (Respiratory Training Group)

Group B : (Aerobic Training Group)

Group C : (control group)

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Complete blood picture
A venous blood sample will be taken to be analyzed in the laboratory
Arterial blood gases
arterial blood sample will be assessed
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.
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.
Oxygen saturation
Percentage of haemoglobin saturated with oxygen measured by pulse oximeter
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

Secondary Outcome Measures

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)

Full Information

First Posted
October 30, 2020
Last Updated
December 24, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04613050
Brief Title
Effect of Respiratory Versus Aerobic Training on Respiratory and Immunity Efficiency in Recovered COVID- 19 Patients
Official Title
Effect of Respiratory Versus Aerobic Training on Respiratory and Immunity Efficiency in Recovered COVID- 19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid 19 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (Respiratory Training Group)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B : (Aerobic Training Group)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group C : (control group)
Arm Type
No Intervention
Arm Description
It will include 20 patients of both sexes, recovered from COVID-19 infection on medical drugs only will receive no exercise as control group.
Intervention Type
Other
Intervention Name(s)
Respiratory Training
Intervention Description
Respiratory training in form of : Diaphragmatic breathing,Segmental breathing, Incentive spirometer:
Intervention Type
Other
Intervention Name(s)
Aerobic training
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete blood picture
Description
A venous blood sample will be taken to be analyzed in the laboratory
Time Frame
change from baseline at 6 weeks
Title
Arterial blood gases
Description
arterial blood sample will be assessed
Time Frame
change from baseline at 6 weeks
Title
6-minute walk Distance
Description
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.
Time Frame
change from baseline at 6 weeks
Title
Breath-hold test
Description
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.
Time Frame
change from baseline at 6 weeks
Title
Oxygen saturation
Description
Percentage of haemoglobin saturated with oxygen measured by pulse oximeter
Time Frame
change from baseline at 6 weeks
Title
Borg Dyspnea Scale score
Description
It is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during six minute walk test
Time Frame
change from baseline at 6 weeks
Secondary Outcome Measure Information:
Title
Maximum oxygen consumption
Description
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)
Time Frame
change from baseline at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Police hospital-Nasr city
City
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

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

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