Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cerebral Palsy
  • Children
  • Exercise
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 10 years and 16 years
Gender
Both males and females

Description

A randomized controlled intervention trial with a crossover design with a one-year follow-up will be performed to explore the differential acute and long-term effects of A) high intensity interval training (HIIT) and of B) steady state training (SST) among non-ambulatory children with CP, ambulatory...

A randomized controlled intervention trial with a crossover design with a one-year follow-up will be performed to explore the differential acute and long-term effects of A) high intensity interval training (HIIT) and of B) steady state training (SST) among non-ambulatory children with CP, ambulatory children with CP and non-disabled children. Non-ambulatory children with CP will walk in the robotic medical device Innowalk. Ambulatory children with CP and non-disabled children will cycle on a cycle ergometer. As the numbers of eligible children in Skåne County, Sweden, are low and due to heterogeneity among the children with CP, a crossover design is chosen to maximize statistical power. Aim 1: Acute response to exercise Objectives: The aim is to elucidate the acute effects form one bout of SST and one bout of HIIT in the three groups of children. Research question: Are there differences in the physiological responses in BDNF, NGF, VEGF and metabolic bio-markers from one acute bout of HIIT and one acute bout of SST exercise among non-ambulatory children with CP, ambulatory children with CP and non-disabled children? Methodology: Indirect calorimetry will be used during one acute bout of HIIT exercise and SST exercise to assess markers of ventilation, circulation, fat versus carbohydrate oxidation, and energy expenditure during exercise. Blood will be collected before and after the exercise testing to assess differences in BDNF, NGF, VEGF and metabolic bio-markers. Temperature at the feet will be assessed to analyze vasodilation. Deliverables: To demonstrate biomarkers of cardiopulmonary and metabolic function and BDNF, NGF, VEGF, that are the most effected by one bout of HIIT and one bout of SST among non-ambulatory children with CP, ambulatory children with CP and non-disabled children and to elucidate if there are differences between the three groups of children. Aim 2: Adaptation to exercise Objectives: The aim is to elucidate the adaptation to 16 weeks of two types of structured training regimes (HIIT vs. SST) on cardiopulmonary and metabolic parameters and BDNF, NGF, VEGF, in the three groups of children. Research question: Are there differences in the physiological adaptation to HIIT exercise and SST exercise among non-ambulatory children with CP, ambulatory children with CP and non-disabled children? Methodology: We will use supervised exercise training of 16 weeks with HIIT -16 weeks Washout -16 weeks with SST, starting and ending with the exercise testing described in Aim 1 to evaluate adaptation to HIIT and SST. Deliverables: To demonstrate changes in cardiopulmonary and metabolic parameters and BDNF, NGF, VEGF in adaptation to HIIT and SST and to elucidate whether there are differences between HIIT and SST among the three groups of children. Aim 3: Adherence to physical activity and exercise; child-family perspective Objectives: The aim is to study the adherence to the two exercise regimes among non-ambulatory children with CP, ambulatory children with CP and non-disabled children and to elucidate health and well-being factors for the child and their family. Research question: Which are the facilitating and hindering factors to participate in structured and standardized exercise regimes and which factors are affecting health and well-being within a child-family perspective, professional caregivers and the child-family perspective and the within the healthcare system? Methodology: The methods used will be a combination of questionnaires and semi-structured interviews individually and in focus groups. Deliverables: Description of facilitating and hindering factors for adherence in the exercise regimes among the three groups of children, and furthermore a description of factors facilitating and hindering health and well-being. Aim 4: Long-term effects from exercise Objectives: The aim is to study the physiological long-term effects of the exercise intervention programs at a one-year follow-up and the adherence to exercise among non-ambulatory children with CP, ambulatory children with CP and non-disabled children. Research question: Which are the physiological adaptations to exercise and which are the facilitating and hindering factors to long-term participation in exercise regimes? Methodology: The methods in Aim 1 and Aim 3 will be used to answer the research question. Deliverables: Description of long-term physiological effects from exercise and facilitating and hindering factors for adherence long-term to exercise among non-ambulatory children with CP, ambulatory children with CP and non-disabled children, and furthermore a description of factors facilitating and hindering health and well-being.

Tracking Information

NCT #
NCT04307602
Collaborators
  • The Swedish Research Council
  • Region Skane
  • Halmstad University
Investigators
Not Provided