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Completed

NCT Number: NCT05216549

Water and Land-based Exercise for Children With Post COVID-19 Condition

The latest data indicate that post COVID-19 condition is frequent in children and adolescents, with the most common symptoms being fatigue, shortness of breath, exercise intolerance and weakness. Evidence that COVID-19 can have significant long-term effects on children's health highlights the need for measures to reduce the impact of the pandemic on children, ensuring that they receive appropriate treatments. Those experiencing post COVID-19 condition require more tailored exercise-related advice and improved support to be able to resume activities important to their individual well-being. To the best of our knowledge, no studies have yet addressed the issue of exercise programs for children with post COVID-19 condition.

The aim of this study, therefore, is to evaluate the effectiveness of different interventions on pulmonary function, exercise capacity, fatigue and quality of life in children with post COVID-19 condition.

This will be a randomized controlled study with pre and post intervention assessment. Children will be recruited from primary schools and primary health care units in Warsaw. Participants meeting the inclusion criteria will be randomized to one of 3 groups: water-based exercise, land-based exercise or control (no exercise). The water-based and land-based exercise groups will be held twice a week, 45 min per session for 8 weeks. Participants will be assessed at baseline and immediately post-intervention in terms of changes in pulmonary function, exercise capacity, fatigue and quality of life. Research outcomes will build the evidence-based practice for health professionals.

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Key information

Conditions

COVID-19 Children, Only Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Lung Function Decreased Nidovirales Infections Pneumonia Pneumonia, Viral Quality of Life RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jozef Pilsudski University of Physical Education in Warsaw

Warsaw, 00-968, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • presenting symptoms of post-COVID-19 condition confirmed by the diagnosis by general practitioner (including obligatory fatigue and shortness of breath/respiratory problems)
  • age 10-12 yrs old
  • adapted to aquatic setting
  • <12 pts in the Ruffier test

Exclusion criteria

  • contraindications to exercise
  • chest pain
  • physical activity trainings more than 2 times per week one month prior the study

Treatment and study plan

Water-Based Exercise

Other

8 weeks x 2 times per week for 45 min

Land-Based Exercise

Other

8 weeks x 2 times per week for 45 min

Primary outcomes

  1. Exercise capacity

    Time frame: 8 weeks (post intervention)

    Exercise capacity will be measured with the use of modification of the Balke treadmill protocol previously validated on a large population-based sample of children ages 7-18 years. Breathing parameters will be measured continuously by the "breath-to breath" method using an ergospirometer Cortex MetaMax 3B system (Biophysik GmbH, Leipzig, Germany). Output from the gas analyses will be sampled at 15 s intervals and stored for use in the calculation of the Oxygen-Uptake Efficiency Slope (OUES).

  2. Fatigue

    Time frame: 8 weeks (post intervention)

    The fatigue will be assessed with the Polish adaptation of the Chronic Fatigue Syndrome Questionnaire. The questionnaire allows to determine the level of chronic fatigue and severity of individual symptoms: general fatigue, decreased vitality, mental overload, somatic symptoms, anxiety and discouragement. It includes 59 statements with one of the possible answers: "never", "sometimes", "often" - the answers are assigned the values 0, 1, 2, respectively. The higher the score, the greater the severity of the symptoms of chronic fatigue.

Secondary outcomes

  1. Health-related quality of life

    Time frame: 8 weeks (post intervention)

    Health-related quality of life will be assessed with the PedsQL - a brief, standardized, generic assessment instrument that systematically assesses perception of HRQOL in healthy children and adolescents and those with acute and chronic health conditions.

  2. Forced vital capacity (FVC)

    Time frame: 8 weeks (post intervention)

    FVC will be measured using the MES Lung Handy spirometer. Measurements will be repeated three times at five-minute intervals, and the highest score will be selected for analysis.

  3. Forced expiratory volume/one second (FEV 1)

    Time frame: 8 weeks (post intervention)

    FEV 1 will be measured using the MES Lung Handy spirometer. Measurements will be repeated three times at five-minute intervals, and the highest score will be selected for analysis.

  4. Maximal expiratory flow at 25% of forced vital capacity (MEF25)

    Time frame: 8 weeks (post intervention)

    MEF25 will be measured using the MES Lung Handy spirometer. Measurements will be repeated three times at five-minute intervals, and the highest score will be selected for analysis.

Sponsors and collaborators

Lead sponsor

Józef Piłsudski University of Physical Education

Other

Collaborators

  • Polish National Agency for Academic Exchange
  • University of Sydney

Registry information

Acronym: postcovidkids

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2022
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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