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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00965133
Other study ID # Shdir-08/4914
Secondary ID
Status Completed
Phase N/A
First received August 24, 2009
Last updated June 10, 2013
Start date September 2009
Est. completion date February 2011

Study information

Verified date June 2013
Source Reidun Lauglo
Contact n/a
Is FDA regulated No
Health authority Norway: Directorate of Health
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 17 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Norway Rosenborgklinikken Trondheim

Sponsors (4)

Lead Sponsor Collaborator
Reidun Lauglo Norwegian University of Science and Technology, Rosenborgklinikken, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Aerobic capacity Sept. 2009 - april 2010 No
Secondary Quality of life Sept. 2009 - April 2010 No
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