Exercise Intervention for Sleep in Neurodevelopmental Disorders

NCT04416789 | Completed

• 1 other identifier: 237572
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

There is a long-standing assumption that physical activity is an effective, non-pharmacological approach to improving sleep quality and quantity. However, objective and reliable data on this relationship are scarce for children with developmental disabilities. Parent burnout in this population is high and there are many barriers to engagement with such interventions. This study aims to understand the feasibility of providing an exercise intervention for this population, and gathering parental views on the impact of such an intervention. Depending on the outcome of this feasibilty study, larger scale interventions may be planned to further examine the impact of such an intervention.

Conditions

Neurodevelopmental Disorders; Sleep Disorder

Keywords

children; sleep; exercise; neurodevelopment; feasibility

Outcome Measures

Primary Outcomes (2)

• Acceptability of the exercise intervention to families

  Measured by attrition rate

  Collected in three months following end of intervention

• Acceptability of the exercise intervention to families

  Measure by semi-structured questionnaire; how likely would you be to recommend the activity; how accessible was the venue; how appropriate was the activity to your child's needs; any other comments; with 5-point Likert scale

  Collected in three months following end of intervention

Secondary Outcomes (2)

• Impact on the sleep pattern of partaking children

  For 2 weeks prior to intervention, and for last 2 weeks of intervention

• Impact on the child and family's wellbeing

  Collected within three months following end of intervention

Interventions

Exercise programme OTHER

1 session of trampolining/dry sports (1.5 hours) and 1 session of supervised swimming (1.5 hours) per week for 10 weeks.

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 5 years to 15 years 11 months attending the Community Sleep Clinic (a dedicated Sleep Clinic for children with neurodevelopmental disorders); all levels of disability will be catered for within the exercise intervention

You may qualify if:

• Diagnosed neurodevelopmental disability Open to the Lambeth and Southwark Community Sleep Clinic Age range: 5 years 0 months - 15 years 11months.

You may not qualify if:

• High risk safeguarding concerns
• Health issues where the intervention has the potential to have an adverse effect on the child e.g. undiagnosed/untreated epilepsy

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE5 8UH, United Kingdom

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders; Sleep Wake Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: June 4, 2020
• Study Start: February 14, 2019
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: June 4, 2020

Record last verified: 2019-02

Locations

GB (1)