Clinical trial NCT06448520: Reference Values for the Muscle Power Sprint Test
Official title: Reference Values for the Muscle Power Sprint Test in Children Aged 5-12 Years
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Development, Child
Activity, Motor
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 480
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this prospective, cross-sectional study is to develop updated reference values for the Muscle Power Sprint Test (MPST) in children aged 5-12 years.

The main question it aims to answer is:

• What are reference ('normal') values for the MPST in children aged 5-12 years?

Participants will be asked to perform six short sprints of fifteen meters each, with a ten-second rest between each effort.

Detailed description: SUMMARY Rationale: Children with congenital abnormalities face risks of below-average lung function and exercise tolerance (1-3). As the standard of care, our tertiary hospital enrolls these children in a prospective, longitudinal follow-up program from birth (4). This program involves regular assessments of overall health and development, including spirometry and exercise tolerance tests conducted by pediatric physiotherapists. Historically, the Bruce treadmill protocol was employed for testing maximal exercise tolerance in children aged 4 and above, but it presented limitations such as high muscular demands of the steep inclines and large workload increments, impacting reliability and potentially causing premature discontinuation (5).

In response, the Bruce protocol was replaced in newer follow-up program versions by the Muscle Power Sprint Test (MPST). Unlike the Bruce protocol, which assesses aerobic capacity, the MPST focuses on anaerobic exercise capacity, which is crucial for children's daily activities like playing with peers (6). Performing the MPST involves six short runs of 15 meters, from which the calculated 'mean power' serves as the primary outcome. The distance covered during these runs corresponds well to the distances children cover during daily play activities.

While Dutch norm values for children aged 6-18 exist, gathered mainly in rural areas between 2012 and 2016, the study highlights the need for updated reference values. Lifestyle changes, exacerbated by the Covid-19 pandemic, underscore the urgency of updating exercise tolerance reference values (7). Notably, there is a current lack of established reference values for 5-year-olds undergoing MPST testing in our longitudinal follow-up program, emphasizing the need for comparative data in this age group.

Objective: Our primary goal is to establish reference values for the MPST for primary school children aged 5-12 belonging to a diverse population living in the Netherlands.

Study design: The study adopts a prospective cross-sectional design.

Study population: Primary school or after-school childcare children aged 5-12 years.

Intervention (if applicable): The MPST, which involves six 15-meter sprints at maximum pace between the two cones/lines, with a 10-second rest in between each effort.

Main study parameters/endpoints: The primary outcome is generating reference values for the MPST for typical children aged 5-12.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: We believe the risks of experiencing drawbacks from study participation are minimal. The Muscle Power Sprint Test (MPST) is non-invasive, involving six short, consecutive 15-meter sprints - similar to activities children commonly engage in, such as games like tag or hide-and-seek - with a 10-second rest after every run. Individual testing and warm-up rounds further mitigate potential risks, and we estimate the likelihood of injuries or adverse effects to be lower than those encountered in a standard physical education class.

Eligibility criteria: Inclusion Criteria:

* Age 5-12 years
* Attending primary education at one of the participating schools or attending participating after-school childcare centers.

Exclusion Criteria:

* Contra-indication for maximal exercise due to cardiac or respiratory morbidities
* Injuries limiting maximal exercise capacity
* Known with motor function impairment which may hamper maximal exercise (e.g. neurologic comorbidities)

Primary outcomes:
measure: Reference values for the MPST for children aged 5-12 years, both male and female.
timeFrame: Data gathering: 6 months, data processing: 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC, Sophia Children's Hospital
state: South Holland
Study officials:
affiliation: Erasmus Medical Center
name: Marco Schnater, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hijkoop A, van Schoonhoven MM, van Rosmalen J, Tibboel D, van der Cammen-van Zijp MHM, Pijnenburg MW, Cohen-Overbeek TE, Schnater JM, IJsselstijn H. Lung function, exercise tolerance, and physical growth of children with congenital lung malformations at 8 years of age. Pediatr Pulmonol. 2019 Aug;54(8):1326-1334. doi: 10.1002/ppul.24345. Epub 2019 Apr 22.
citation: Schaan CW, Macedo ACP, Sbruzzi G, Umpierre D, Schaan BD, Pellanda LC. Functional Capacity in Congenital Heart Disease: A Systematic Review and Meta-Analysis. Arq Bras Cardiol. 2017 Oct;109(4):357-367. doi: 10.5935/abc.20170125. Epub 2017 Sep 4.
citation: Toussaint-Duyster LCC, van der Cammen-van Zijp MHM, de Jongste JC, Tibboel D, Wijnen RMH, Gischler SJ, van Rosmalen J, IJsselstijn H. Congenital diaphragmatic hernia and exercise capacity, a longitudinal evaluation. Pediatr Pulmonol. 2019 May;54(5):628-636. doi: 10.1002/ppul.24264. Epub 2019 Feb 11.
citation: Gischler SJ, Mazer P, Duivenvoorden HJ, van Dijk M, Bax NM, Hazebroek FW, Tibboel D. Interdisciplinary structural follow-up of surgical newborns: a prospective evaluation. J Pediatr Surg. 2009 Jul;44(7):1382-9. doi: 10.1016/j.jpedsurg.2008.12.034.
citation: Fredriksen PM, Ingjer F, Nystad W, Thaulow E. Aerobic endurance testing of children and adolescents--a comparison of two treadmill-protocols. Scand J Med Sci Sports. 1998 Aug;8(4):203-7. doi: 10.1111/j.1600-0838.1998.tb00193.x.
citation: Bailey RC, Olson J, Pepper SL, Porszasz J, Barstow TJ, Cooper DM. The level and tempo of children's physical activities: an observational study. Med Sci Sports Exerc. 1995 Jul;27(7):1033-41. doi: 10.1249/00005768-199507000-00012.
citation: Stockwell S, Trott M, Tully M, Shin J, Barnett Y, Butler L, McDermott D, Schuch F, Smith L. Changes in physical activity and sedentary behaviours from before to during the COVID-19 pandemic lockdown: a systematic review. BMJ Open Sport Exerc Med. 2021 Feb 1;7(1):e000960. doi: 10.1136/bmjsem-2020-000960. eCollection 2021.