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COVID-19NCT06008470

Investigation of Respiratory Muscle Strength, Exercise Capacity, Physical Activity and Sleep Quality Level in Individuals With Covid-19 Infection

An observational study of COVID-19 and Sleep Disorder, run by Kırıkkale University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

COVID-19 infection was identified in Wuhan, China at the end of 2019 and turned into a pandemic in a short time. In our country, the pandemic continues at full speed and patients are being treated in various clinical pictures. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, Sleep Disorder, Respiratory Failure
What is being tested?
observational tests
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2023to 25 Feb 2024
Phase
Observational
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: As a result of the power analysis performed according to the sample article, it was calculated that 95% power would be obtained with 95% confidence when 30 people were included in each group for a total of 60 people. The MMP value was taken as the primary outcome measure. The impact factor was calculated as 0.958. Individuals will be selected from the students of our department. 30 people are post-covid, 30 people are healthy control group

Who may be able to join

  • - Literacy,
  • To be between the ages of 18-45,
  • To study at Kırıkkale University Faculty of Health Sciences
  • Volunteering to participate in the research,

Who cannot join

  • - Individuals who are professional athletes with musculoskeletal system, cardiopulmonary system, metabolic system and other systemic problems that may affect physical activity habits will not be included in the study.
  • A repeat COVID-19 PCR test positivity within the last 12 weeks

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kırıkkale University

    Kirikkale, 71450

Other trials in Turkey (Türkiye)

About this study

COVID-19 infection was identified in Wuhan, China at the end of 2019 and turned into a pandemic in a short time. In our country, the pandemic continues at full speed and patients are being treated in various clinical pictures. In its clinical classification, the World Health Organization (WHO) divides COVID-19 disease into four stages: mild symptomatic disease, pneumonia, severe pneumonia, acute respiratory distress syndrome (ARDS), sepsis and advanced stage with septic shock. Case reports and cross-sectional studies report a list of more than 200 different symptoms in the development of post COVID-19 syndrome. Shortness of breath, persistent smell and taste disturbances, fatigue and neuropsychological symptoms (headache, memory loss, slowed thinking, anxiety, depression and sleep disturbances) are the most commonly reported symptoms. Musculoskeletal symptoms such as pain (myalgia), muscle weakness, arthralgia and fatigue are also common. Exercise endurance tests are used to predict the prognosis of the disease in chronic lung diseases, to determine functional exercise capacity, to evaluate the response of the disease to treatment and to interpret the results of clinical trials. Covid-19-induced lung infections and long periods of isolation may have negative effects on respiratory muscle strength, pulmonary function values and physical activity level. It has been reported that only one week of bed rest can cause serious muscle loss of up to 20%. Covid-19 infection increases the likelihood of asthma-like symptoms. In some cases, pneumonia and increased dyspnea are also seen. When volleyball players with Covid-19 infection were examined, respiratory muscle strength and fev1/fvc values were lower than expected.

When looking at the interaction between infections and sleep, it was observed that different infections had different effects on sleep, with some infections increasing the amount of sleep while others decreased it. The increase in inflammatory mediators associated with systemic infection is thought to increase the amount of REM sleep and total sleep duration, perhaps in an effort to conserve energy and counteract infection. Some infections have a negative effect on the immune system, reducing the amount of sleep. Covid infection is also thought to have negative effects on sleep. The symptoms of COVID-19 in the chronic phase can further negatively affect physiological, psychological and social outcomes, physical activity and ultimately muscle performance and quality. Post-infection physical function and fitness can worsen even two years after the disease.

Read more

In COVID-19 patients recovering 3 months after hospital discharge, limitations were mainly related to reduced muscle mass, low oxidative capacity or both, rather than cardiac or respiratory exercise limitation.

Symptoms experienced during Covid-19 infection are thought to have negative effects on exercise endurance. In order to meet the metabolic needs of the musculoskeletal system muscles during exercise, cardiac output, ventilation, pulmonary and systemic blood flow, oxygen and carbon dioxide exchange in a way to maintain acid-base balance and oxygenation, and their compatible response to each other are required. Exercise endurance assessments are an important parameter to determine the functional level of the patient. Eighty-eight percent of individuals with Covid-19 infection showed a decrease in respiratory muscle strength in the evaluation performed 5 months later. The direct effect of respiratory muscles may cause permanent dyspnea problems. Muscle strength, exercise capacity, dyspnea perception, fatigue severity perception, pain, balance, kinesiophobia, psychosocial and cognitive status, quality of life should be routinely evaluated in the post-COVID-19 period in patients admitted to the clinic, and a targeted functional rehabilitation program should be prepared in the light of these evaluations, taking these parameters into consideration during the rehabilitation process.

Being tested
observational tests
Medical subject headings
COVID-19, Sleep Wake Disorders, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observational testsOther

    Respiratory Muscle Strength Measurement In our study, respiratory muscle strength will be measured using a portable, electronic mouth pressure measuring device (MEC Pocket Spiro MPM100, Belgium). Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurement is one of the most commonly used non-invasive methods to evaluate respiratory muscles.

    6 Minute Walk Test (6MWT): It has been used to assess physical activity and functional capacity in many pulmonary rehabilitation programs for patients with chronic pulmonary disease and limited respiratory capacity

Study groups in NCT06008470
Study groupRoleWhat they receive
covid-19Inclusion Criteria: * Literacy, * To be between the ages of 18-45, * To study at Kırıkkale University Faculty of Health Sciences * Volunteering to participate in the research,
Receives: Other: observational tests
controlNot described
Receives: Other: observational tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 Minute Walk Test (6MWT):

    The 6DYT is a simple, low-cost test that monitors blood pressure (BP), heart rate (HR), respiratory frequency (RF), 'pulse' oxygen saturation (SpO2), score on the Borg Scale and distance walked. This test allows determination of physical fitness and VO2max and also assesses the patient's capacity and exercise tolerance.

    Measured: 6 min

Secondary outcomes (2)
  1. Sleep Quality Level(pitsburg sleep scale)

    The PSQI was developed by Buysse et al. (1989) and adapted into Turkish by Ağargün et al. (1996). The PSQI is a 19-item self-report scale that evaluates sleep quality and disturbance in the past one month. It consists of 24 questions, 19 questions are self-report questions and 5 questions are questions to be answered by a spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficacy, Sleep Disorder, Sleep Medication Use and Daytime Dysfunction. Each component is evaluated on a 0-3 point scale. The total score of the 7 components gives the total scale score. The total score ranges from 0-21. A total score greater than 5 indicates "poor sleep quality"

    Measured: 5 minute

  2. Respiratory Muscle Strength Measurement

    In our study, respiratory muscle strength will be measured using a portable, electronic mouth pressure measuring device (MEC Pocket Spiro MPM100, Belgium). Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurement is one of the most commonly used non-invasive methods to evaluate respiratory muscles

    Measured: 10 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completion15 Jan 2024
  4. Study completion25 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06008470
Sponsor's protocol ID
Gurbuz04
Status last verified
Feb 2024
First submitted
21 Aug 2023
Last updated
1 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Sleep Disorder, run by Kırıkkale University at 1 site in Turkey (Türkiye).

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 2 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 1 Mar 2024. 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 Turkey (Türkiye). 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?

6 Minute Walk Test (6MWT): (time frame: 6 min). 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 1 Mar 2024.

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