Corona Virus InfectionNCT04996225
Effect of Aerobics and Balancing Exercises on Anxiety and Dizziness in Patients With COVID-19
A study testing Aerobics exercises, Balance exercises in people with Corona Virus Infection, run by Merit University at 1 site in Egypt.
Trial summary
The recently emerged coronavirus named Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) is the newest threat to human health. It has already infected more than half a million people worldwide, leading to a lot of deaths. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- Aerobics exercises, Balance exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 10 Feb 2023
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Thirty patients with COVID-19
- Age between 45 -65 years
- Cooperative patient.
- All patients were referred from physician with the diagnosis of COVID-19
Who cannot join
- Overweigh patients with body mass index more than 30.
- Pregnant women.
- Cancer patients.
- Smokers
- Patients with chronic heart disease
Trial locations and contacts
1 site in 1 country.
About this study
The recently emerged coronavirus named Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) is the newest threat to human health. It has already infected more than half a million people worldwide, leading to a lot of deaths. Patients with Coronavirus Disease 2019(COVID-19) will experience high levels of anxiety and low sleep quality due to isolation treatment. Purposes: Was to investigate the effect of aerobics and balancing exercises on anxiety and dizziness in patients with COVID-19. Subjects: Thirty anxiety and dizziness patients with COVID-19 aged from 45-65 years of both sexes, randomly divided into two groups, selected from outpatient clinic ,General
Read the detailed description
In December 2019, a series of pneumonia cases of unknown cause emerged in Wuhan, Hubei, China, with clinical presentations greatly resembling viral pneumonia. Deep sequencing analysis from lower respiratory tract samples indicated a novel coronavirus, which was named 2019 novel coronavirus Disease (COVID-19). On February 12, 2020, WHO officially named the disease caused by the novel coronavirus as Coronavirus Disease 2019 (COVID-19),and by March 11th, 2020 when the number of countries involved was 114, with more than 118,000 cases and over 4000 deaths, the WHO declared the pandemic status
- Conditions
- Corona Virus Infection
- Being tested
- Aerobics exercises, Balance exercises
- Keywords
- Aerobics - Balance exercises -anxiety - dizziness disorder
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobics exercises, Balance exercisesOther
Aerobic exercise, or endurance exercise, is a subdivision of physical exercise that improves cardiovascular and respiratory health. Additionally, it is generally assumed to increase well-being and reduce negative mood states such as anxiety and depression.
| Study group | Role | What they receive |
|---|---|---|
| Group (A): (study group) | Experimental | Group (A): (study group) 15 patients received aerobics exercises and balancing exercises in addition to relaxation exercises for 4 weeks, 3sessions/week. Receives: Other: Aerobics exercises, Balance exercises |
| Group (B): (Control group) | Placebo comparator | 2-Group (B): (Control group) 15 patients received relaxation exercises in the form of physical relaxation exercise for 4 weeks, 3 sessions/week. the participants who received aerobics exercises and balancing exercises in addition to relaxation exercises (experimental group A), showed significant decrease in anxiety and dizziness more than (placebo group B) Receives: Other: Aerobics exercises, Balance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPSS for Windows, version 22 (SPSS Inc., Chicago, Illinois, USA)
Statistical analysis was carried out using SPSS for Windows, version 22 (SPSS Inc., Chicago, Illinois, USA). The P value is the degree of significant. A P value less than or equal to 0.05 was considered to be significant. Comparison between the mean values of different parameters in the two groups was performed using an unpaired t test. Comparison between pretreatment and post-treatment data in the same group was performed using a paired t test.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Aug 2021
- Primary completion25 Oct 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- 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
- Model description
- Finally, it could be concluded that aerobic exercise and balancing exercise with relaxation exercises decrease anxiety and dizziness in patients with COVID-19. So, it considered as effective, safe, cheap and successful adjunct treatment methods in reducing anxiety and dizziness in patients with COVID-19.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed M Essa, PHD, Study chair, Lecturer of Biomechanics, Faculty of Physical Therapy, Deraya University, Minia,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996225
- Sponsor's protocol ID
- A,B E COVID 19
- Status last verified
- Feb 2023
- First submitted
- 6 Aug 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu H, Stratton CW, Tang YW. Outbreak of pneumonia of unknown etiology in Wuhan, China: The mystery and the miracle. J Med Virol. 2020 Apr;92(4):401-402. doi: 10.1002/jmv.25678. Epub 2020 Feb 12. No abstract available.
PubMed 31950516Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Rajeswari S, SanjeevaReddy N. Efficacy of Progressive Muscle Relaxation on Pregnancy Outcome among Anxious Indian Primi Mothers. Iran J Nurs Midwifery Res. 2019 Dec 27;25(1):23-30. doi: 10.4103/ijnmr.IJNMR_207_18. eCollection 2020 Jan-Feb.
PubMed 31956594Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.
PubMed 26606383Chekroud SR, Gueorguieva R, Zheutlin AB, Paulus M, Krumholz HM, Krystal JH, Chekroud AM. Association between physical exercise and mental health in 1.2 million individuals in the USA between 2011 and 2015: a cross-sectional study. Lancet Psychiatry. 2018 Sep;5(9):739-746. doi: 10.1016/S2215-0366(18)30227-X. Epub 2018 Aug 8.
PubMed 30099000
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobics and Balancing Exercises on Anxiety and Dizziness in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04996225
- Acronym / sponsor ID
- A,B E COVID 19
- Conditions
- Corona Virus Infection
- Keywords
- Aerobics - Balance exercises -anxiety - dizziness disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merit UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 9 Aug 2021 (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.
The recently emerged coronavirus named Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) is the newest threat to human health. It has already infected more than half a million people worldwide, leading to a lot of deaths. Patients with Coronavirus Disease 2019(COVID-19) will experience high levels of anxiety and low sleep quality due to isolation treatment. Purposes: Was to investigate the effect of aerobics and balancing exercises on anxiety and dizziness in patients with COVID-19. Subjects: Thirty anxiety and dizziness patients with COVID-19 aged from 45-65 years of both sexes, randomly divided into two groups, selected from outpatient clinic ,General
Detailed description
In December 2019, a series of pneumonia cases of unknown cause emerged in Wuhan, Hubei, China, with clinical presentations greatly resembling viral pneumonia. Deep sequencing analysis from lower respiratory tract samples indicated a novel coronavirus, which was named 2019 novel coronavirus Disease (COVID-19). On February 12, 2020, WHO officially named the disease caused by the novel coronavirus as Coronavirus Disease 2019 (COVID-19),and by March 11th, 2020 when the number of countries involved was 114, with more than 118,000 cases and over 4000 deaths, the WHO declared the pandemic status
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Finally, it could be concluded that aerobic exercise and balancing exercise with relaxation exercises decrease anxiety and dizziness in patients with COVID-19. So, it considered as effective, safe, cheap and successful adjunct treatment methods in reducing anxiety and dizziness in patients with COVID-19.
| Arm | Type | Receives |
|---|---|---|
| Group (A): (study group) | Experimental | Other: Aerobics exercises, Balance exercisesGroup (A): (study group) 15 patients received aerobics exercises and balancing exercises in addition to relaxation exercises for 4 weeks, 3sessions/week. |
| Group (B): (Control group) | Placebo comparator | Other: Aerobics exercises, Balance exercises2-Group (B): (Control group) 15 patients received relaxation exercises in the form of physical relaxation exercise for 4 weeks, 3 sessions/week. the participants who received aerobics exercises and balancing exercises in addition to relaxation exercises (experimental group A), showed significant decrease in anxiety and dizziness more than (placebo group B) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Thirty patients with COVID-19
- Age between 45 -65 years
- Cooperative patient.
- All patients were referred from physician with the diagnosis of COVID-19
Key exclusion criteria (5 listed)
- Overweigh patients with body mass index more than 30.
- Pregnant women.
- Cancer patients.
- Smokers
- Patients with chronic heart disease
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 |
|---|---|---|
| Aerobics exercises, Balance exercisesAerobic exercise, or endurance exercise, is a subdivision of physical exercise that improves cardiovascular and respiratory health. Additionally, it is generally assumed to increase well-being and reduce negative mood states such as anxiety and depression. | Other | Group (A): (study group), Group (B): (Control group) |
Primary outcome
SPSS for Windows, version 22 (SPSS Inc., Chicago, Illinois, USA)
Time frame: one month
Statistical analysis was carried out using SPSS for Windows, version 22 (SPSS Inc., Chicago, Illinois, USA). The P value is the degree of significant. A P value less than or equal to 0.05 was considered to be significant. Comparison between the mean values of different parameters in the two groups was performed using an unpaired t test. Comparison between pretreatment and post-treatment data in the same group was performed using a paired t test.
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 22 Feb 2023.
- Background: PubMed 31950516Lu H, Stratton CW, Tang YW. Outbreak of pneumonia of unknown etiology in Wuhan, China: The mystery and the miracle. J Med Virol. 2020 Apr;92(4):401-402. doi: 10.1002/jmv.25678. Epub 2020 Feb 12. No abstract available.
- Background: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background: PubMed 31956594Rajeswari S, SanjeevaReddy N. Efficacy of Progressive Muscle Relaxation on Pregnancy Outcome among Anxious Indian Primi Mothers. Iran J Nurs Midwifery Res. 2019 Dec 27;25(1):23-30. doi: 10.4103/ijnmr.IJNMR_207_18. eCollection 2020 Jan-Feb.
- Background: PubMed 26606383Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.
- Background: PubMed 30099000Chekroud SR, Gueorguieva R, Zheutlin AB, Paulus M, Krumholz HM, Krystal JH, Chekroud AM. Association between physical exercise and mental health in 1.2 million individuals in the USA between 2011 and 2015: a cross-sectional study. Lancet Psychiatry. 2018 Sep;5(9):739-746. doi: 10.1016/S2215-0366(18)30227-X. Epub 2018 Aug 8.
Related trials for Corona Virus Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
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.
Mohamed M Essa, PHD study chair
Lecturer of Biomechanics, Faculty of Physical Therapy, Deraya University, Minia,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobics exercises, Balance exercises in people with Corona Virus Infection, run by Merit 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 4 inclusion and 5 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 22 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
SPSS for Windows, version 22 (SPSS Inc., Chicago, Illinois, USA) (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04996225, which also lists 5 linked publications.
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 22 Feb 2023.