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

NCT05216549 | Completed

• 1 other identifier: BPN/GIN/2021/1/00071/U/00001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  8 weeks (post intervention)

Secondary Outcomes (4)

• Health-related quality of life

  8 weeks (post intervention)

• Forced vital capacity (FVC)

  8 weeks (post intervention)

• Forced expiratory volume/one second (FEV 1)

  8 weeks (post intervention)

• Maximal expiratory flow at 25% of forced vital capacity (MEF25)

  8 weeks (post intervention)

Study Arms (3)

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.

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.

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.

Interventions

Water-based exercise OTHER

8 weeks x 2 times per week for 45 min

Water-based exercise

Land-based exercise OTHER

8 weeks x 2 times per week for 45 min

Land-based exercise

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• contraindications to exercise
• chest pain
• physical activity trainings more than 2 times per week one month prior the study

Sponsors & Collaborators

• Józef Piłsudski University of Physical Education: lead
• Polish National Agency for Academic Exchange: collaborator
• University of Sydney: collaborator

Study Sites (1)

Jozef Pilsudski University of Physical Education in Warsaw

Warsaw, 00-968, Poland

Location

Related Publications (1)

• 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.

  PMID: 36361362 RESULT

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Anna Ogonowska-Slodownik, PhD

  Józef Piłsudski University of Physical Education in Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: January 31, 2022
• Study Start: January 1, 2022
• Primary Completion: June 5, 2022
• Study Completion: June 30, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

PL (1)