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

January 6, 2023 updated by: Anna Ogonowska-Słodownik, Józef Piłsudski University of Physical Education

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 00-968
        • Jozef Pilsudski University of Physical Education in Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Water-based exercise
8 weeks x 2 times per week for 45 min
Experimental: 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.
Other: Land-based exercise
8 weeks x 2 times per week for 45 min
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
8 weeks (post intervention)
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.
8 weeks (post intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks (post intervention)
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.
8 weeks (post intervention)
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.
8 weeks (post intervention)
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.
8 weeks (post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Józef Piłsudski University of Physical Education

Collaborators

University of Sydney
Polish National Agency for Academic Exchange

Investigators

  • Principal Investigator: Anna Ogonowska-Slodownik, PhD, Józef Piłsudski University of Physical Education in Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 5, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPN/GIN/2021/1/00071/U/00001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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