COVID-19postcovidkidsNCT05216549
Water and Land-based Exercise for Children With Post COVID-19 Condition
A study testing Water-based exercise and Land-based exercise in people with COVID-19 and Children, Only, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- COVID-19, Children, Only, Lung Function Decreased
- What is being tested?
- Water-based exercise and Land-based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- contraindications to exercise
- chest pain
- physical activity trainings more than 2 times per week one month prior the study
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jozef Pilsudski University of Physical Education in Warsaw
Warsaw, 00-968
About this study
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
- Being tested
- Water-based exercise, Land-based exercise
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-based exerciseOther
8 weeks x 2 times per week for 45 min
Land-based exerciseOther
8 weeks x 2 times per week for 45 min
| Study group | Role | What they receive |
|---|---|---|
| Water-based exercise | Experimental | 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. Receives: Other: Water-based exercise |
| Land-based exercise | Experimental | 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. Receives: Other: Land-based exercise |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks (post intervention)
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.
Measured: 8 weeks (post intervention)
Secondary outcomes (4)
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.
Measured: 8 weeks (post intervention)
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.
Measured: 8 weeks (post intervention)
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.
Measured: 8 weeks (post intervention)
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.
Measured: 8 weeks (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Jan 2022
- Primary completion5 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- Polish National Agency for Academic Exchange, University of Sydney
- Responsible party
- Principal investigator, Anna Ogonowska-Słodownik, Józef Piłsudski University of Physical Education
- Investigators
- Anna Ogonowska-Slodownik, PhD, Principal investigator, Józef Piłsudski University of Physical Education in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216549
- Sponsor's protocol ID
- BPN/GIN/2021/1/00071/U/00001
- Acronym
- postcovidkids
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36361362
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water and Land-based Exercise for Children With Post COVID-19 Condition
- ClinicalTrials.gov ID
- NCT05216549
- Acronym / sponsor ID
- postcovidkids / BPN/GIN/2021/1/00071/U/00001
- Conditions
- COVID-19, Children, Only, Lung Function Decreased, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Collaborators
- Polish National Agency for Academic Exchange, University of Sydney
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water-based exercise | Experimental | Other: Water-based exerciseThe 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. |
| Land-based exercise | Experimental | Other: Land-based exerciseThe 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- contraindications to exercise
- chest pain
- physical activity trainings more than 2 times per week one month prior the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water-based exercise8 weeks x 2 times per week for 45 min | Other | Water-based exercise |
| Land-based exercise8 weeks x 2 times per week for 45 min | Other | Land-based exercise |
Primary outcome
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).
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.
4 secondary outcomes
Health-related quality of life
Time frame: 8 weeks (post intervention)
Forced vital capacity (FVC)
Time frame: 8 weeks (post intervention)
Forced expiratory volume/one second (FEV 1)
Time frame: 8 weeks (post intervention)
Maximal expiratory flow at 25% of forced vital capacity (MEF25)
Time frame: 8 weeks (post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Results publication: PubMed 36361362Ogonowska-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Ogonowska-Slodownik, PhD principal investigator
Józef Piłsudski University of Physical Education in Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-based exercise and Land-based exercise in people with COVID-19 and Children, Only, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: 8 weeks (post intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05216549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.