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

COVID-19 Clinical Trial

— postcovidkids  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05216549
• Other study ID #: BPN/GIN/2021/1/00071/U/00001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2023
• Source: Józef Pilsudski University of Physical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 30, 2022
• Est. primary completion date: June 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Children, Only
• COVID-19
• Lung Function Decreased
• Quality of Life

Intervention

Other:
• Water-based exercise
8 weeks x 2 times per week for 45 min
• Land-based exercise
8 weeks x 2 times per week for 45 min

Locations

Country	Name	City	State
Poland	Jozef Pilsudski University of Physical Education in Warsaw	Warsaw

Sponsors (3)

Lead Sponsor	Collaborator
Józef Pilsudski University of Physical Education	Polish National Agency for Academic Exchange, University of Sydney

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Ogonowska-Slodownik A, Labecka MK, Kaczmarczyk K, McNamara RJ, Starczewski M, Gajewski J, Maciejewska-Skrendo A, Morgulec-Adamowicz N. Water-Based and Land-Based Exercise for Children with Post-COVID-19 Condition (postCOVIDkids)-Protocol for a Randomized — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity	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).	8 weeks (post intervention)
Primary	Fatigue	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.	8 weeks (post intervention)
Secondary	Health-related quality of life	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.	8 weeks (post intervention)
Secondary	Forced vital capacity (FVC)	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.	8 weeks (post intervention)
Secondary	Forced expiratory volume/one second (FEV 1)	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.	8 weeks (post intervention)
Secondary	Maximal expiratory flow at 25% of forced vital capacity (MEF25)	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.	8 weeks (post intervention)

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