ExerciseLEERNCT04307602
Long-term Exercise Effects from Robotic Walking
A study testing Exercise - High Intensity Interval Training (HIIT) and Exercise - Submaximal Steady State Training (SST) in people with Exercise and Children, run by Lund University at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Children, Cerebral Palsy
- What is being tested?
- Exercise - High Intensity Interval Training (HIIT) and Exercise - Submaximal Steady State Training (SST)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Exercise Effects from Robotic Walking Among Children with Severe Cerebral Palsy
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.
Read more
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.
Read the 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.
- Conditions
- Exercise, Children, Cerebral Palsy
- Being tested
- Exercise - High Intensity Interval Training (HIIT), Exercise - Submaximal Steady State Training (SST)
- Keywords
- Physical Activity, Physical Fitness, Physical Exertion, Health
- Medical subject headings
- Motor Activity, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise - High Intensity Interval Training (HIIT)Other
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
Exercise - Submaximal Steady State Training (SST)Other
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
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy GMFCS IV-V | Experimental | Exercise intervention in the waling aide Innowalk Receives: Other: Exercise - High Intensity Interval Training (HIIT); Other: Exercise - Submaximal Steady State Training (SST) |
| Children with cerebral palsy GMFCS I-II | Active comparator | Exercise intervention on spinning bikes Receives: Other: Exercise - High Intensity Interval Training (HIIT); Other: Exercise - Submaximal Steady State Training (SST) |
| Children without disabilities | Active comparator | Exercise intervention on spinning bikes Receives: Other: Exercise - High Intensity Interval Training (HIIT); Other: Exercise - Submaximal Steady State Training (SST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain derived neurotropic factor (BDNF)
Measured: 12 months
Secondary outcomes (2)
Nerve growth factor (NGF)
Measured: 12 months
Vascular endothelial growth factor (VEGF)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 May 2019
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Region Skane, Halmstad University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307602
- Sponsor's protocol ID
- LU2019LEER
- Other IDs
- 2018-02433, 2019-00106, 2022-00729, 2019, 2018
- Acronym
- LEER
- Status last verified
- Sep 2024
- First submitted
- 9 Mar 2020
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Exercise Effects from Robotic Walking Among Children with Severe Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04307602
- Acronym / sponsor ID
- LEER / LU2019LEER
- Conditions
- Exercise, Children, Cerebral Palsy
- Keywords
- Physical Activity, Physical Fitness, Physical Exertion, Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Region Skane, Halmstad University
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy GMFCS IV-V | Experimental | Other: Exercise - High Intensity Interval Training (HIIT), Other: Exercise - Submaximal Steady State Training (SST)Exercise intervention in the waling aide Innowalk |
| Children with cerebral palsy GMFCS I-II | Active comparator | Other: Exercise - High Intensity Interval Training (HIIT), Other: Exercise - Submaximal Steady State Training (SST)Exercise intervention on spinning bikes |
| Children without disabilities | Active comparator | Other: Exercise - High Intensity Interval Training (HIIT), Other: Exercise - Submaximal Steady State Training (SST)Exercise intervention on spinning bikes |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise - High Intensity Interval Training (HIIT)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 | Other | Children with cerebral palsy GMFCS I-II, Children with cerebral palsy GMFCS IV-V, Children without disabilities |
| Exercise - Submaximal Steady State Training (SST)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 | Other | Children with cerebral palsy GMFCS I-II, Children with cerebral palsy GMFCS IV-V, Children without disabilities |
Primary outcome
Brain derived neurotropic factor (BDNF)
Time frame: 12 months
2 secondary outcomes
Nerve growth factor (NGF)
Time frame: 12 months
Vascular endothelial growth factor (VEGF)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise - High Intensity Interval Training (HIIT) and Exercise - Submaximal Steady State Training (SST) in people with Exercise and Children, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain derived neurotropic factor (BDNF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.