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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04613050
Collaborator
(none)
80
1
3
21.9
3.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Respiratory Training
  • Other: Aerobic training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Respiratory Versus Aerobic Training on Respiratory and Immunity Efficiency in Recovered COVID- 19 Patients
Actual Study Start Date :
Jul 2, 2020
Anticipated Primary Completion Date :
Apr 24, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Complete blood picture [change from baseline at 6 weeks]

    A venous blood sample will be taken to be analyzed in the laboratory

  2. Arterial blood gases [change from baseline at 6 weeks]

    arterial blood sample will be assessed

  3. 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.

  4. 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.

  5. Oxygen saturation [change from baseline at 6 weeks]

    Percentage of haemoglobin saturated with oxygen measured by pulse oximeter

  6. 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

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Police hospital-Nasr city Cairo Egypt 002

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heba Ahmed Ali Abdeen, Assistant Professor, Cairo University
ClinicalTrials.gov Identifier:
NCT04613050
Other Study ID Numbers:
  • MAHA2020
First Posted:
Nov 3, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022