Cerebral Palsy & Predictors of Physical Activity

NCT04614207 | Completed

• 1 other identifier: 1-Fonvig
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

Children and adolescents with cerebral palsy may be trapped in a vicious circle of low physical fitness, early fatigue in daily activities, resulting in deconditioning and a further decrease in physical activity. From this perspective, establishing a healthy and active lifestyle during childhood is even more important for individuals with a disability, who are at higher risk for functional limitations and general fatigue in addition with developing secondary' conditions such as cardiovascular disease, diabetes, and obesity. Furthermore, physical activity has a positive impact on quality of life, but it remains unknown which factors that influence high levels of habitual physical activity in children and adolescents with cerebral palsy. The present research project will investigate predictors of habitual physical activity in children and adolescents with cerebral palsy with the perspective of providing evidence on optimizing physical activity and consequently improved overall health.

Conditions

Cerebral Palsy

Keywords

Physical activity; Accelerometry; Quality of life; Children; Adolescents

Outcome Measures

Primary Outcomes (1)

• Model 1a: Prediction of habitual physical activity using data from the CPUP registry

  Habitual physical activity will be assessed objectively using accelerometer counts. Multiple linear regression analyzes between accelerometer counts (response variable) and all CPUP variables within each ICF (International Classification of Functioning, Disability and Health) component as predictive variables, using the latest CPUP registration prior to accelerometer data collection.

  Response variable is measured between 0 and 39 months post registry data (predictive variables).

Secondary Outcomes (3)

• Model 1b: Prediction of habitual physical activity using data from questionnaire variables

  Response variable is measured between 1 and 15 months post registry data (predictive variables).

• Model 2a: Prediction of habitual physical activity using data from the CPUP registry (penalized regression)

  Response variable is measured between 0 and 39 months post registry data (predictive variables).

• Model 2b: Prediction of habitual physical activity using data from questionnaire variables (penalized regression)

  Accelerometer data is collected 1-15 months post collection of questionnaire data.

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children and adolescents between the ages of 8 and 15 years, diagnosed with cerebral palsy in Denmark. The study population will be selected thru the Danish Health Data Authority ('Sundhedsdatastyrelsen') where social security numbers of parents/guardians sharing an adresse with an individual from the study population, will be used as a means of contact.

You may qualify if:

• Children born in the timeperiod 2003 - 2013
• Diagnosed with cerebral palsy (according to current classifications)
• Gross Motor Function Classification System (GMFCS) level I - III
• Registered in the Cerebral Palsy Follow-up Registry (CPUP), Denmark (As explained in the Statistical Analysis Plan dated June 6, 2022, CPUP data will be used were available. However, being registred in the CPUP database is no longer a requirement).

You may not qualify if:

• \- Parents/guardians unable to read and understand Danish.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Elsass Foundation: collaborator
• Region of Southern Denmark: collaborator
• AJ Andersen og Hustrus Fond: collaborator
• The Hede Nielsen Family Foundation: collaborator
• Dagmar Marshalls Fond: collaborator
• Fonden til Lægevidenskabens Fremme: collaborator

Study Sites (1)

University of Southern Denmark

Odense C, 5000, Denmark

Location

Related Publications (1)

• Fonvig CE, Troelsen J, Dunkhase-Heinl U, Lauritsen JM, Holsgaard-Larsen A. Predictors of physical activity levels in children and adolescents with cerebral palsy: clinical cohort study protocol. BMJ Open. 2021 Sep 21;11(9):e047522. doi: 10.1136/bmjopen-2020-047522.

  PMID: 34548350 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Anders Holsgaard-Larsen, Assoc. Prof

  Department of Clinical Research, University of Southern Denmark.

  STUDY DIRECTOR

• Christina E Fonvig, MSc

  Department of Clinical Research, University of Southern Denmark.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 3, 2020
• Study Start: November 3, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)