Clinical trial NCT05216549: Water and Land-based Exercise for Children With Post COVID-19 Condition
Official title: Water and Land-based Exercise for Children With Post COVID-19 Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Children, Only
Lung Function Decreased
Quality of Life
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
Collaborators: name: Polish National Agency for Academic Exchange
name: University of Sydney
First posted: 2022-01-31
Enrollment: 75
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Exercise capacity
timeFrame: 8 weeks (post intervention)
measure: Fatigue
timeFrame: 8 weeks (post intervention)
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 8 weeks (post intervention)
measure: Forced vital capacity (FVC)
timeFrame: 8 weeks (post intervention)
measure: Forced expiratory volume/one second (FEV 1)
timeFrame: 8 weeks (post intervention)
measure: Maximal expiratory flow at 25% of forced vital capacity (MEF25)
timeFrame: 8 weeks (post intervention)
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Jozef Pilsudski University of Physical Education in Warsaw
Study officials:
affiliation: Józef Piłsudski University of Physical Education in Warsaw
name: Anna Ogonowska-Slodownik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Controlled Trial. Int J Environ Res Public Health. 2022 Nov 4;19(21):14476. doi: 10.3390/ijerph192114476.