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Effect of Aerobics and Balancing Exercises on Anxiety and Dizziness in Patients With COVID-19

Primary Purpose

Corona Virus Infection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobics exercises, Balance exercises
Sponsored by
Merit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corona Virus Infection focused on measuring Aerobics - Balance exercises -anxiety - dizziness disorder

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Thirty patients with COVID-19
  • Age between 45 -65 years
  • Cooperative patient.
  • All patients were referred from physician with the diagnosis of COVID-19

Exclusion Criteria:

  • Overweigh patients with body mass index more than 30.
  • Pregnant women.
  • Cancer patients.
  • Smokers
  • Patients with chronic heart disease

Sites / Locations

  • Ahmed.Assem

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group (A): (study group)

Group (B): (Control group)

Arm Description

Group (A): (study group) 15 patients received aerobics exercises and balancing exercises in addition to relaxation exercises for 4 weeks, 3sessions/week.

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2021
Last Updated
February 20, 2023
Sponsor
Merit University
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1. Study Identification

Unique Protocol Identification Number
NCT04996225
Brief Title
Effect of Aerobics and Balancing Exercises on Anxiety and Dizziness in Patients With COVID-19
Official Title
Effect of Aerobics and Balancing Exercises on Anxiety and Dizziness in Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
February 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merit University

4. Oversight

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

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection
Keywords
Aerobics - Balance exercises -anxiety - dizziness disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (A): (study group)
Arm Type
Experimental
Arm Description
Group (A): (study group) 15 patients received aerobics exercises and balancing exercises in addition to relaxation exercises for 4 weeks, 3sessions/week.
Arm Title
Group (B): (Control group)
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Aerobics exercises, Balance exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
SPSS for Windows, version 22 (SPSS Inc., Chicago, Illinois, USA)
Description
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.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Thirty patients with COVID-19 Age between 45 -65 years Cooperative patient. All patients were referred from physician with the diagnosis of COVID-19 Exclusion Criteria: Overweigh patients with body mass index more than 30. Pregnant women. Cancer patients. Smokers Patients with chronic heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M Essa, PHD
Organizational Affiliation
Lecturer of Biomechanics, Faculty of Physical Therapy, Deraya University, Minia,
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed.Assem
City
Sohag
ZIP/Postal Code
82951
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
31950516
Citation
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.
Results Reference
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PubMed Identifier
32109013
Citation
Guan 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.
Results Reference
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PubMed Identifier
31956594
Citation
Rajeswari 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.
Results Reference
background
PubMed Identifier
26606383
Citation
Pedersen 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.
Results Reference
background
PubMed Identifier
30099000
Citation
Chekroud 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.
Results Reference
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Effect of Aerobics and Balancing Exercises on Anxiety and Dizziness in Patients With COVID-19

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