Cerebral PalsyNCT00965133
Endurance Training in Young Persons With Cerebral Palsy; Evaluation of Training Method and Effect
A study testing Endurance training intervention in people with Cerebral Palsy, run by Reidun Lauglo at 1 site in Norway.
Trial summary
The hypotheses of the study are that children / youth with CP will by possibly use of technical aids be able to perform high intensity endurance training by walking / running on a treadmill, and that this training will improve their health by increased aerobic capacity and quality of life. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Endurance training intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2009to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Person with CP, GMFCS-level I-IV, age 10-17 years
- Living in Mid-Norway
- Wants to increase his / her level of physical activity
Who cannot join
- Completes less than 75% of the total number of training sessions
- Not able to complete the testing and training procedures due to sickness, injury or other physical and psychological conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enthusiasm - Sweat - Satisfaction! In Youngster With CP
The hypotheses of the study are that children / youth with CP will by possibly use of technical aids be able to perform high intensity endurance training by walking / running on a treadmill, and that this training will improve their health by increased aerobic capacity and quality of life.
- Conditions
- Cerebral Palsy
- Being tested
- Endurance training intervention
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance training interventionOther
High intensive interval training of walking / running on treadmill for 1 1/2 - 4 minute,repeated minimum 4 times, at an intensity equalling at least 80% of maximal heart frequency. Performed 2-5 times per week for 4-8 weeks, totally 24 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Normal daily activity | No intervention | Not described Receives: Other: Endurance training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity
Measured: Sept. 2009 - april 2010
Secondary outcomes (1)
Quality of life
Measured: Sept. 2009 - April 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reidun Lauglo
- Sponsor type
- University, hospital or other
- Collaborators
- Rosenborgklinikken, Norwegian University of Science and Technology, St. Olavs Hospital
- Responsible party
- Principal investigator, Reidun Lauglo, Reidun Lauglo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965133
- Sponsor's protocol ID
- Shdir-08/4914
- Status last verified
- Jun 2013
- First submitted
- 24 Aug 2009
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lauglo R, Vik T, Lamvik T, Stensvold D, Finbraten AK, Moholdt T. High-intensity interval training to improve fitness in children with cerebral palsy. BMJ Open Sport Exerc Med. 2016 May 9;2(1):e000111. doi: 10.1136/bmjsem-2016-000111. eCollection 2016.
PubMed 27900177
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enthusiasm - Sweat - Satisfaction! In Youngster With CP
- ClinicalTrials.gov ID
- NCT00965133
- Acronym / sponsor ID
- Shdir-08/4914
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Reidun LaugloUniversity, hospital or other
- Collaborators
- Rosenborgklinikken, Norwegian University of Science and Technology, St. Olavs Hospital
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 25 Aug 2009 (estimated)
- 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 hypotheses of the study are that children / youth with CP will by possibly use of technical aids be able to perform high intensity endurance training by walking / running on a treadmill, and that this training will improve their health by increased aerobic capacity and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal daily activity | No intervention | Other: Endurance training intervention |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Person with CP, GMFCS-level I-IV, age 10-17 years
- Living in Mid-Norway
- Wants to increase his / her level of physical activity
Key exclusion criteria (2 listed)
- Completes less than 75% of the total number of training sessions
- Not able to complete the testing and training procedures due to sickness, injury or other physical and psychological conditions
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 |
|---|---|---|
| Endurance training interventionHigh intensive interval training of walking / running on treadmill for 1 1/2 - 4 minute,repeated minimum 4 times, at an intensity equalling at least 80% of maximal heart frequency. Performed 2-5 times per week for 4-8 weeks, totally 24 sessions. | Other | Normal daily activity |
Primary outcome
Aerobic capacity
Time frame: Sept. 2009 - april 2010
1 secondary outcome
Quality of life
Time frame: Sept. 2009 - April 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
- Derived from this study: PubMed 27900177Lauglo R, Vik T, Lamvik T, Stensvold D, Finbraten AK, Moholdt T. High-intensity interval training to improve fitness in children with cerebral palsy. BMJ Open Sport Exerc Med. 2016 May 9;2(1):e000111. doi: 10.1136/bmjsem-2016-000111. eCollection 2016.
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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 Endurance training intervention in people with Cerebral Palsy, run by Reidun Lauglo at 1 site in Norway.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 11 Jun 2013. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Aerobic capacity (time frame: Sept. 2009 - april 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00965133, which also lists 1 linked publication.
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 11 Jun 2013.