Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Endurance Training in Young Persons With Cerebral Palsy; Evaluation of Training Method and Effect

This study has been completed.
Sponsor:
Collaborators:
Rosenborgklinikken
Norwegian University of Science and Technology
St. Olavs Hospital
Information provided by (Responsible Party):
Reidun Lauglo
ClinicalTrials.gov Identifier:
NCT00965133
First received: August 24, 2009
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Cerebral Palsy
Other: Endurance training intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enthusiasm - Sweat - Satisfaction! In Youngster With CP

Resource links provided by NLM:


Further study details as provided by Reidun Lauglo:

Primary Outcome Measures:
  • Aerobic capacity [ Time Frame: Sept. 2009 - april 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Sept. 2009 - April 2010 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2009
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Normal daily activity Other: Endurance training intervention
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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Person with CP, GMFCS-level I-IV, age 10-17 years
  • Living in Mid-Norway
  • Wants to increase his / her level of physical activity

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965133

Locations
Norway
Rosenborgklinikken
Trondheim, Norway
Sponsors and Collaborators
Reidun Lauglo
Rosenborgklinikken
Norwegian University of Science and Technology
St. Olavs Hospital
  More Information

No publications provided

Responsible Party: Reidun Lauglo, Physiotherapist
ClinicalTrials.gov Identifier: NCT00965133     History of Changes
Other Study ID Numbers: Shdir-08/4914
Study First Received: August 24, 2009
Last Updated: June 10, 2013
Health Authority: Norway: Directorate of Health

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014