NCT04996225

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

1.2 years

First QC Date

August 6, 2021

Last Update Submit

February 20, 2023

Conditions

Keywords

Aerobics - Balance exercises -anxiety - dizziness disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    one month

Study Arms (2)

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.

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)

Other: Aerobics exercises, Balance exercises

Interventions

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.

Group (A): (study group)Group (B): (Control group)

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed.Assem

Sohag, 82951, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 31950516BACKGROUND
  • 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.

    PMID: 32109013BACKGROUND
  • 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.

    PMID: 31956594BACKGROUND
  • 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.

    PMID: 26606383BACKGROUND
  • 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.

    PMID: 30099000BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Mohamed M Essa, PHD

    Lecturer of Biomechanics, Faculty of Physical Therapy, Deraya University, Minia,

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 9, 2021

Study Start

August 1, 2021

Primary Completion

October 25, 2022

Study Completion

February 10, 2023

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations