Back to resultsProgressive Strength Training in Spinal Muscular Atrophy
Primary Purpose
Muscular Atrophy, Spinal
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progressive strength training
Sponsored by
About this trial
This is an interventional treatment trial for Muscular Atrophy, Spinal focused on measuring Spinal muscular atrophy, Neuromuscular disorder, Progressive strength training, Children
Eligibility Criteria
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
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spinal muscular atrophy
Arm Description
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.
Outcomes
Primary Outcome Measures
Strength
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01233817
Brief Title
Progressive Strength Training in Spinal Muscular Atrophy
Official Title
Pilot Study of Progressive Strength Training in Spinal Muscular Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (Actual)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Atrophy, Spinal
Keywords
Spinal muscular atrophy, Neuromuscular disorder, Progressive strength training, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal muscular atrophy
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Progressive strength training
Intervention Description
the systematic increase in resistance weights
Primary Outcome Measure Information:
Title
Strength
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aga Lewelt, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Progressive Strength Training in Spinal Muscular Atrophy
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