Effects of Physical Training on Bone and Muscle Quality, Muscle Strength, and Motor Coordination in Children With NF1

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Thrasher Research Fund
University of Utah
Information provided by (Responsible Party):
David Stevenson, MD, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT01058330
First received: January 26, 2010
Last updated: February 25, 2013
Last verified: February 2013

January 26, 2010
February 25, 2013
February 2010
February 2014   (final data collection date for primary outcome measure)
Bone & muscle quality, DXA, pQCT, & bone ultrasound. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01058330 on ClinicalTrials.gov Archive Site
Motor proficiency BOT-2. Muscle strength force plate & dynamometer. Quality of life questionnaires. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Physical Training on Bone and Muscle Quality, Muscle Strength, and Motor Coordination in Children With NF1
Effects of Physical Training on Bone and Muscle Quality, Muscle Strength, and Motor Coordination in Children With Neurofibromatosis Type 1

A physical training program will improve quality of life, participation in physical activity, motor coordination, muscle strength, and bone and muscle strength in children with neurofibromatosis type 1.

Disorders of the Ras pathway have significant phenotypic overlap and include Noonan syndrome, CFC syndrome, Legius syndrome, Costello syndrome and neurofibromatosis type 1 (NF1). NF1 is one of the most common genetic disorders presenting in childhood with an incidence of 1/3000. NF1 is associated with skeletal abnormalities such as short stature, scoliosis, and long bone fracture with non-union. We recently reported that children with NF1 have abnormalities of bone and muscle architecture as evidenced by decreased bone mineral density, decreased bone strength, and low muscle mass, all of which may predispose them to fractures and scoliosis (Stevenson et al., 2005, 2007, 2009). Our preliminary data show that children with NF1 have poor motor coordination and muscle strength, potentially secondary to abnormal neuromotor learning. We hypothesize that poor motor coordination and decreased muscle strength contribute to the osteopenia in NF1. Our objective is to identify effective and non-invasive strategies to improve motor coordination, muscle strength, and bone and muscle architecture in children with disorders of the Ras pathway, in hopes of decreasing fractures and improving physical activity levels. Plyometric physical training consists of quick, high-intensity, weight-bearing movements, and is an encouraging intervention for use in these children.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Neurofibromatosis Type 1
Other: Plyometric training program
The intervention is a year long individualized plyometric exercise training program. Examples of plyometric activities include jumping, hopping, running, and throwing. The number of plyometric exercises will increase gradually to prevent over training to a total of 5 lower extremity exercises and 5 upper extremity exercises
  • Active Comparator: Plyometric physical training
    Individualized plyometric training program to increase strength, coordination, and bone density.
    Intervention: Other: Plyometric training program
  • No Intervention: Control Group
    This group will have no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Fulfill NIH clinical diagnostic criteria

Exclusion Criteria:

  • Visual impairment
  • Participation in a simultaneous medical intervention trial
  • Orthopedic procedure within the last 6 months.
  • Pregnancy
  • Home location greater than 3-4 hours drive time from Shriners Hospital
  • Tibial pseudarthrosis
Both
4 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01058330
SLC00038711
No
David Stevenson, MD, Shriners Hospitals for Children
Shriners Hospitals for Children
  • Thrasher Research Fund
  • University of Utah
Principal Investigator: David Stevenson, MD Shriners Hospitals for Children
Shriners Hospitals for Children
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP