We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Progressive Strength Training in Spinal Muscular Atrophy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01233817
First Posted: November 3, 2010
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Utah
October 19, 2010
November 3, 2010
December 5, 2012
March 12, 2013
June 14, 2017
June 2010
June 2013   (Final data collection date for primary outcome measure)
Strength [ Time Frame: 12 weeks ]
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 ]
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
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2013
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
Sexes Eligible for Study: All
5 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01233817
39995
Yes
Not Provided
Not Provided
University of Utah
University of Utah
Not Provided
Principal Investigator: Aga Lewelt, MD University of Utah
University of Utah
May 2017

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