NCT05461391

Brief Summary

World Health Organization (WHO) Novel-19 Corrosion Disease (COVID) in 2019 without being used by a pathway caused by the SARS-CoV-2 virus. After the acute period in COVID-19 patients, muscle weakness may continue in breathing, weakness, and training. The effects on core stabilization, pulmonary functions, respiratory muscle strength, physical activity scores and quality of life in healthy adults who do not have COVID-19 who do regular exercise may be higher than in healthy adults who do regular exercise with COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

February 12, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

February 12, 2022

Last Update Submit

August 17, 2023

Conditions

COVID-19Pandemic, COVID-19Corona Virus Infection

Keywords

covid-19coronavirusrespiratory physiotherapycore stabilization

Outcome Measures

Primary Outcomes (4)

  • Pulmonary Function Test

    Medical International Research Spirodoc® Spiro spirometry will evaluate the respiratory functions of Italian brand volunteers. Lung function tests can determine both expected values and deviations of lung volumes. Spirometry has been used for over 150 years. Spirometry tests objectively evaluate both inspiratory and expiratory patients. The test will be repeated three times, and the best values will be recorded before and after the interventions.

    8 weeks

  • Respiratory Muscle Strength

    Mikro Medical Micro RPM is aimed to measure Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) values. During the application, maximum effort is requested, and the patient will be shown the test beforehand. During the measurement of MIP and MEP, it is closed with a nose clip, and after a deep breath, volunteers will be asked to give a maximum exhale for 1 to 3 seconds.

    8 weeks

  • Six Minute Walk Test (6MWT)

    The 6MWT is a test that patients most commonly use, is valid, inexpensive, popular, easy to tolerate, easy to use, has minimal technological resources, and shows daily activity compared to other walking tests. They will be asked to walk at the same speed for 6 minutes, but not to run, on a 30-meter straight corridor. The volunteers' distance walked in 6 minutes will be calculated and evaluated.

    8 weeks

  • McGill Core Endurance Test

    McGill Core Endurance Test consists of 4 different test positions. It assesses the core endurance of volunteers.

    8 weeks

Secondary Outcomes (3)

  • International Physical Activity Questionnaire - Short Form (IPAQ-SF)

    8 weeks

  • Quality of Life Scale (SF36)

    8 weeks

  • Dyspnea Scale

    8 weeks

Study Arms (2)

Study Group

Participants who got COVID-19.

Control Group

Healthy participants

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Data will be evaluated in healthy adult volunteers who agreed to participate in the clinical study at Bezmialem Vakıf University Dragos Hospital between February and April.

You may qualify if:

  • To be between the ages of 18-50,
  • Volunteering to participate in the research,
  • Those who have done aerobic exercise at least three days a week in the last three months

You may not qualify if:

  • Neurological deficits in the upper or lower extremities,
  • Fractures or orthopedic problems in the upper or lower extremities,
  • Cardiovascular diseases that prevent rehabilitation,
  • Systematic rheumatic disease (rheumatoid arthritis, ankylosing spondylitis),
  • History of surgery in the last three months,
  • Patients with spine problems,
  • Smokers,
  • Patients with chronic respiratory problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University Dragos Hospital

Istanbul, Maltepe, Turkey (Türkiye)

Location

Related Publications (8)

  • Chiumello D, Coppola S, Froio S, Gotti M. What's Next After ARDS: Long-Term Outcomes. Respir Care. 2016 May;61(5):689-99. doi: 10.4187/respcare.04644.

    PMID: 27121623BACKGROUND

  • Cavaggioni L, Ongaro L, Zannin E, Iaia FM, Alberti G. Effects of different core exercises on respiratory parameters and abdominal strength. J Phys Ther Sci. 2015 Oct;27(10):3249-53. doi: 10.1589/jpts.27.3249. Epub 2015 Oct 30.

    PMID: 26644685BACKGROUND

  • The Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. The Epidemiological Characteristics of an Outbreak of 2019 Novel Coronavirus Diseases (COVID-19) - China, 2020. China CDC Wkly. 2020 Feb 21;2(8):113-122. No abstract available.

    PMID: 34594836BACKGROUND

  • Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.

    PMID: 32064853BACKGROUND

  • Chhabra SK. Clinical application of spirometry in asthma: Why, when and how often? Lung India. 2015 Nov-Dec;32(6):635-7. doi: 10.4103/0970-2113.168139. No abstract available.

    PMID: 26664177BACKGROUND

  • Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.

    PMID: 22018588BACKGROUND

  • FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.

    PMID: 13003946BACKGROUND

  • Develi E, Subasi F, Aslan GK, Bingol Z. The effects of core stabilization training on dynamic balance and pulmonary parameters in patients with asthma. J Back Musculoskelet Rehabil. 2021;34(4):639-648. doi: 10.3233/BMR-191803.

    PMID: 33720873RESULT

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • ildeniz yalnız

    Bezmialem Vakif University Dragos Hospital

    STUDY DIRECTOR

  • elif develi

    Yeditepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

February 12, 2022

First Posted

July 18, 2022

Study Start

March 15, 2022

Primary Completion

May 15, 2022

Study Completion

June 30, 2022

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)