Progressive Strength Training in Spinal Muscular Atrophy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01233817
First received: October 19, 2010
Last updated: February 5, 2013
Last verified: February 2013

October 19, 2010
February 5, 2013
June 2010
June 2013   (final data collection date for primary outcome measure)
Strength [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Primary Outcome Measure was muscle strength. Strength was measured using a fixed myometry evaluation, quantitative muscle analysis (QMA). QMA utilizes a relative fixed point for the participant to exert effort. Each muscle of interest was tested using QMA.
Strength [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
maximum voluntary isometric contraction (MVIC): Hand held dynamometry (HHD) and quantitative muscle analysis (QMA)
Complete list of historical versions of study NCT01233817 on ClinicalTrials.gov Archive Site
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Progressive Strength Training in Spinal Muscular Atrophy
Pilot Study of Progressive Strength Training in Spinal Muscular Atrophy

The proposed feasibility study is necessary to test if children and young adults will participate in and adhere to a 12-week, home-based, supervised progressive strength training exercise program and to obtain preliminary data that will subsequently allow us to determine the safety and impact of strength training in spinal muscular atrophy. Our pilot study will address 3 aims: (1) Ascertain the feasibility of, and potential barriers to, participation in and adherence to a 12-week home-based, supervised, progressive strength training exercise program in children and young adults aged 5-21 years with SMA types II and III; (2) Determine the safety and tolerability of progressive strength training in a pilot study sample of children and young adults with SMA types II and III; and (3) Determine candidate outcome measures.

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Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Muscular Atrophy, Spinal
Other: Progressive strength training
the systematic increase in resistance weights
Experimental: Spinal muscular atrophy
Children and adolescents with diagnosis of SMA type II or III. The intervention group (the only arm/group in this pilot study) receives a home-based, supervised, 12-week progressive strength-training program.
Intervention: Other: Progressive strength training
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
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June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 5-21 years
  • diagnosis of SMA type II or III
  • at least antigravity strength in elbow flexors
  • ability to follow commands and stay on task
  • place of residence within a 60-minute or 60-mile drive of the University of Utah

Exclusion Criteria:

  • planned surgery or out-of-town trips during the proposed intervention period
  • inability to travel to study center for testing
  • neurological diagnosis other than SMA
Both
5 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01233817
39995
Yes
University of Utah
University of Utah
Not Provided
Principal Investigator: Aga Lewelt, MD University of Utah
University of Utah
February 2013

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