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

NCT01058330 | Completed

• 1 other identifier: SLC00038711
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Neurofibromatosis Type 1

Keywords

Neurofibromatosis type 1; NF1

Outcome Measures

Primary Outcomes (1)

• Bone & muscle quality, DXA, pQCT, & bone ultrasound.

  1 year

Secondary Outcomes (1)

• Motor proficiency BOT-2. Muscle strength force plate & dynamometer. Quality of life questionnaires.

  1 year

Study Arms (2)

Plyometric physical training

ACTIVE COMPARATOR

Individualized plyometric training program to increase strength, coordination, and bone density.

Other: Plyometric training program

Control Group

NO INTERVENTION

This group will have no intervention

Interventions

Plyometric training program OTHER

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 five lower extremity exercises and five upper extremity exercises

Plyometric physical training

Eligibility Criteria

• Age: 4 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Fulfill NIH clinical diagnostic criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Shriners Hospitals for Children: lead
• Thrasher Research Fund: collaborator
• University of Utah: collaborator

Study Sites (2)

Shriners Hospitals for Children, Salt Lake City

Salt Lake City, Utah, 84103, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Neurofibromatosis 1

Condition Hierarchy (Ancestors)

Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David Stevenson, MD

  Shriners Hospitals for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Medical Genetics, University of Utah

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 28, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)