search
Back to results

Long-term Exercise Effects From Robotic Walking (LEER)

Primary Purpose

Exercise, Children, Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise - High Intensity Interval Training (HIIT)
Exercise - Submaximal Steady State Training (SST)
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Exercise focused on measuring Physical Activity, Physical Fitness, Physical Exertion, Health

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • non-ambulatory children with CP defined as GMFCS-E&R IV-V, ambulatory children with CP defined as GMFCS-E&R I-II and healthy controls: non-disabled children not participating in any regular and planned physical exercise.

Exclusion Criteria:

  • Ambulatory children with CP walking with a walking aid (GMFCS-E&R III); non-disabled children with other neurological diagnoses, metabolic diagnoses, orthopaedic disabilities, asthma, heart diseases, cognitive impairments or indigestion of regular medication.

Sites / Locations

  • Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Children with cerebral palsy GMFCS IV-V

Children with cerebral palsy GMFCS I-II

Children without disabilities

Arm Description

Exercise intervention in the waling aide Innowalk

Exercise intervention on spinning bikes

Exercise intervention on spinning bikes

Outcomes

Primary Outcome Measures

Brain derived neurotropic factor (BDNF)

Secondary Outcome Measures

Nerve growth factor (NGF)
Vascular endothelial growth factor (VEGF)

Full Information

First Posted
March 9, 2020
Last Updated
April 29, 2021
Sponsor
Lund University
Collaborators
The Swedish Research Council, Region Skane, Halmstad University
search

1. Study Identification

Unique Protocol Identification Number
NCT04307602
Brief Title
Long-term Exercise Effects From Robotic Walking
Acronym
LEER
Official Title
Long-term Exercise Effects From Robotic Walking Among Children With Severe Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University
Collaborators
The Swedish Research Council, Region Skane, Halmstad University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The vision of the Long-term Exercise Effects from Robotic Walking (LEER) research program is to develop optimal, individualized exercise strategies that would in turn enhance the health and well-being of non-ambulatory children with cerebral palsy (CP). To date, it has not been possible to study exercise among non-ambulatory children with cerebral palsy in a structured and standardized manner. Improved possibilities to carry out such studies are now offered by the robotic medical device Innowalk, which allows various training options in an upright weight-bearing position. In order to design optimal exercise strategies for children with cerebral palsy, the investigators will examine the effects of two tailored training programs, using Innowalk. Changes in cardiopulmonary and metabolic parameters, and in the levels of brain derived neurotropic factor (BDNF), nerve growth factor (NGF) and vascular endothelial growth factor (VEGF) will be examined. The investigators will assess the acute (1 day), adaptive (16 weeks), and long-term (1 year) effects of the exercise programs through indirect calorimetry and blood samples at multiple time points. The investigators will also study the environmental and behavioral factors facilitating and hindering participation in exercise, by semi-structured interviews. The goal is to design improved individualized exercise programs that will increase health and well-being in the children and their families, thereby decreasing the use of medications and healthcare.
Detailed 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Children, Cerebral Palsy
Keywords
Physical Activity, Physical Fitness, Physical Exertion, Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children with cerebral palsy GMFCS IV-V
Arm Type
Experimental
Arm Description
Exercise intervention in the waling aide Innowalk
Arm Title
Children with cerebral palsy GMFCS I-II
Arm Type
Active Comparator
Arm Description
Exercise intervention on spinning bikes
Arm Title
Children without disabilities
Arm Type
Active Comparator
Arm Description
Exercise intervention on spinning bikes
Intervention Type
Other
Intervention Name(s)
Exercise - High Intensity Interval Training (HIIT)
Intervention Description
Exercise in the walk aid Innowalk for children for children with CP GMFCS IV-V, Exercise on spinning bike for children with CP GMFCS I-II and non-disabled children
Intervention Type
Other
Intervention Name(s)
Exercise - Submaximal Steady State Training (SST)
Intervention Description
Exercise in the walk aid Innowalk for children for children with CP GMFCS IV-V, Exercise on spinning bike for children with CP GMFCS I-II and non-disabled
Primary Outcome Measure Information:
Title
Brain derived neurotropic factor (BDNF)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Nerve growth factor (NGF)
Time Frame
12 months
Title
Vascular endothelial growth factor (VEGF)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: non-ambulatory children with CP defined as GMFCS-E&R IV-V, ambulatory children with CP defined as GMFCS-E&R I-II and healthy controls: non-disabled children not participating in any regular and planned physical exercise. Exclusion Criteria: Ambulatory children with CP walking with a walking aid (GMFCS-E&R III); non-disabled children with other neurological diagnoses, metabolic diagnoses, orthopaedic disabilities, asthma, heart diseases, cognitive impairments or indigestion of regular medication.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Åsa B Tornberg, Associate Professor
Phone
+46-46-222 97 66
Email
asa.tornberg@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Katarina Lauruschkus, PhD
Email
katarina.lauruschkus@med.lu.se
Facility Information:
Facility Name
Health Sciences Centre
City
Lund
State/Province
Skania
ZIP/Postal Code
221 00
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Åsa B Tornberg, Associate Professor
Phone
+46-46-2229766
Email
asa.tornberg@med.lu.se
First Name & Middle Initial & Last Name & Degree
Katarina Lauruschkus, PhD
Email
katarina.lauruschkus@med.lu.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Long-term Exercise Effects From Robotic Walking

We'll reach out to this number within 24 hrs