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

Primary Purpose

COVID-19, Children, Only, Lung Function Decreased

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Water-based exercise
Land-based exercise
Sponsored by
Józef Piłsudski University of Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

10 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jozef Pilsudski University of Physical Education in Warsaw

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Water-based exercise

Land-based exercise

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 26, 2022
Last Updated
January 6, 2023
Sponsor
Józef Piłsudski University of Physical Education
Collaborators
Polish National Agency for Academic Exchange, University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT05216549
Brief Title
Water and Land-based Exercise for Children With Post COVID-19 Condition
Acronym
postcovidkids
Official Title
Water and Land-based Exercise for Children With Post COVID-19 Condition
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 5, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Józef Piłsudski University of Physical Education
Collaborators
Polish National Agency for Academic Exchange, University of Sydney

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Children, Only, Lung Function Decreased, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water-based exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Land-based exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Water-based exercise
Intervention Description
8 weeks x 2 times per week for 45 min
Intervention Type
Other
Intervention Name(s)
Land-based exercise
Intervention Description
8 weeks x 2 times per week for 45 min
Primary Outcome Measure Information:
Title
Exercise capacity
Description
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).
Time Frame
8 weeks (post intervention)
Title
Fatigue
Description
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.
Time Frame
8 weeks (post intervention)
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
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.
Time Frame
8 weeks (post intervention)
Title
Forced vital capacity (FVC)
Description
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.
Time Frame
8 weeks (post intervention)
Title
Forced expiratory volume/one second (FEV 1)
Description
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.
Time Frame
8 weeks (post intervention)
Title
Maximal expiratory flow at 25% of forced vital capacity (MEF25)
Description
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.
Time Frame
8 weeks (post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Ogonowska-Slodownik, PhD
Organizational Affiliation
Józef Piłsudski University of Physical Education in Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jozef Pilsudski University of Physical Education in Warsaw
City
Warsaw
ZIP/Postal Code
00-968
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
36361362
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.
Results Reference
result
Links:
URL
http://www.mdpi.com/1660-4601/19/21/14476
Description
Related Info

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

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