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

NCT ID: NCT05216549

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Water-based exercise

The water-based exercise group will be held twice a week, 45 min per session for 8 weeks. Supervised exercise will be led by the experienced physiotherapist and water-based exercise by physiotherapist with aquatic exercise expertise.Each session will consist of warm up (10 min), main part (30 min) and cool-down (5 min). During warm up children will perform lower and upper limbs aerobics and breathing exercises. The main part will consist of endurance exercises of upper and lower limbs with focus on breathing pattern. During cool-down focus will be on upper limb and thoracic cage stretches and breathing control.

Group Type: EXPERIMENTAL

Water-based exercise

Intervention Type: OTHER

8 weeks x 2 times per week for 45 min

Land-based exercise

The land-based exercise group will be held twice a week, 45 min per session for 8 weeks. Supervised exercise will be led by the experienced physiotherapist and water-based exercise by physiotherapist with aquatic exercise expertise.Each session will consist of warm up (10 min), main part (30 min) and cool-down (5 min). During warm up children will perform lower and upper limbs aerobics and breathing exercises. The main part will consist of endurance exercises of upper and lower limbs with focus on breathing pattern. During cool-down focus will be on upper limb and thoracic cage stretches and breathing control.

Group Type: EXPERIMENTAL

Land-based exercise

Intervention Type: OTHER

8 weeks x 2 times per week for 45 min

Control

The control group will be asked not to change their physical activity for 8 weeks. After that period and post-test the control group will receive the exercise.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Water-based exercise

8 weeks x 2 times per week for 45 min

Intervention Type: OTHER

Land-based exercise

8 weeks x 2 times per week for 45 min

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polish National Agency for Academic Exchange

UNKNOWN

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: collaborator

Józef Piłsudski University of Physical Education

OTHER

Sponsor Role: lead

Responsible Party

Anna Ogonowska-Słodownik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Ogonowska-Slodownik, PhD

Role: PRINCIPAL_INVESTIGATOR

Józef Piłsudski University of Physical Education in Warsaw

Locations

Jozef Pilsudski University of Physical Education in Warsaw

Warsaw, , Poland

Countries

Poland

References

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.

Reference Type: RESULT

PMID: 36361362 (View on PubMed)

Other Identifiers

BPN/GIN/2021/1/00071/U/00001

Identifier Type: -

Identifier Source: org_study_id