Covid 19 InfectionNCT04613050
Effect of Respiratory Versus Aerobic Training on Respiratory and Immunity Efficiency in Recovered COVID- 19 Patients
A study testing Respiratory Training and Aerobic training in people with Covid 19 Infection, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 35 to 45 years
- Conditions the study is for
- Covid 19 Infection
- What is being tested?
- Respiratory Training and Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2020to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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%
Who cannot join
- Smokers
- Patients with Myocardial infarction
- Patients with diabetes.
- Patients with autoimmune disease.
- Patients with positive COVID -19 infection.
- Patients with previous chest diseases
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Covid 19 Infection
- Being tested
- Respiratory Training, Aerobic training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory TrainingOther
Respiratory training in form of :
Diaphragmatic breathing,Segmental breathing, Incentive spirometer:
Aerobic trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group A (Respiratory Training Group) | Active comparator | 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. Receives: Other: Respiratory Training |
| Group B : (Aerobic Training Group) | Active comparator | 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 Receives: Other: Aerobic training |
| Group C : (control group) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Complete blood picture
A venous blood sample will be taken to be analyzed in the laboratory
Measured: change from baseline at 6 weeks
Arterial blood gases
arterial blood sample will be assessed
Measured: 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.
Measured: 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.
Measured: change from baseline at 6 weeks
Oxygen saturation
Percentage of haemoglobin saturated with oxygen measured by pulse oximeter
Measured: 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
Measured: change from baseline at 6 weeks
Secondary outcomes (1)
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)
Measured: change from baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start2 Jul 2020
- Primary completion24 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid 19 InfectionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Ali Abdeen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613050
- Sponsor's protocol ID
- MAHA2020
- Status last verified
- Dec 2022
- First submitted
- 30 Oct 2020
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Respiratory Versus Aerobic Training on Respiratory and Immunity Efficiency in Recovered COVID- 19 Patients
- ClinicalTrials.gov ID
- NCT04613050
- Acronym / sponsor ID
- MAHA2020
- Conditions
- Covid 19 Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Respiratory Training Group) | Active comparator | Other: Respiratory TrainingIt 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) | Active comparator | Other: Aerobic trainingIt 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) | No intervention | –It will include 20 patients of both sexes, recovered from COVID-19 infection on medical drugs only will receive no exercise as control group. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (10 listed)
- Smokers
- Patients with Myocardial infarction
- Patients with diabetes.
- Patients with autoimmune disease.
- Patients with positive COVID -19 infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory TrainingRespiratory training in form of : Diaphragmatic breathing,Segmental breathing, Incentive spirometer: | Other | Group A (Respiratory Training Group) |
| Aerobic trainingaerobic 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 | Other | Group B : (Aerobic Training Group) |
Primary outcome
Complete blood picture
Time frame: change from baseline at 6 weeks
A venous blood sample will be taken to be analyzed in the laboratory
Arterial blood gases
Time frame: change from baseline at 6 weeks
arterial blood sample will be assessed
6-minute walk Distance
Time frame: 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
Time frame: 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
Time frame: change from baseline at 6 weeks
Percentage of haemoglobin saturated with oxygen measured by pulse oximeter
Borg Dyspnea Scale score
Time frame: 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
1 secondary outcome
Maximum oxygen consumption
Time frame: change from baseline at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Training and Aerobic training in people with Covid 19 Infection, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete blood picture (time frame: change from baseline at 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.