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

NCT ID: NCT06008470

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-02-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Sleep Disorder Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

covid-19

Inclusion 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,

observational tests

Intervention Type OTHER

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

control

observational tests

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

observational tests

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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,

Exclusion Criteria

* \- 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kırıkkale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alper Kemal Gürbüz

research asistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kırıkkale University

Kırıkkale, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Gurbuz04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.