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Progressive Strength Training in Spinal Muscular Atrophy

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ClinicalTrials.gov Identifier: NCT01233817
Recruitment Status : Completed
First Posted : November 3, 2010
Results First Posted : March 12, 2013
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Muscular Atrophy, Spinal
Intervention Other: Progressive strength training
Enrollment 12
Recruitment Details Participants were recruited from May 2010 until February 2012. Some participants were recruited during clinic visits and others contacted us after being informed of the study
Pre-assignment Details This was a pilot study and all participants were in the treatment group
Arm/Group Title Spinal Muscular Atrophy
Hide Arm/Group Description Children and adolescents with diagnosis of SMA type II or III
Period Title: Overall Study
Started 12
Completed 9
Not Completed 3
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             2
Arm/Group Title Spinal Muscular Atrophy
Hide Arm/Group Description Children and adolescents with diagnosis of SMA type II or III
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
8
  88.9%
Between 18 and 65 years
1
  11.1%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
9.56  (3.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
5
  55.6%
Male
4
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Strength
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Muscular Atrophy
Hide Arm/Group Description:
Children and adolescents with diagnosis of SMA type II or III
Overall Number of Participants Analyzed 9
Median (95% Confidence Interval)
Unit of Measure: kilograms
0.39
(-0.5 to 1.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Spinal Muscular Atrophy
Hide Arm/Group Description Children and adolescents with diagnosis of SMA type II or III
All-Cause Mortality
Spinal Muscular Atrophy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Spinal Muscular Atrophy
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Spinal Muscular Atrophy
Affected / at Risk (%)
Total   0/9 (0.00%) 
This was a pilot study with only one arm, the treatment arm. This is an inherent limitation.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aga Lewelt MD, Principal Investigator
Organization: Department of Physical Medicine and Rehabilitation, School of Medicine, University of Utah
Phone: 801-518-4572
EMail: aga@genetics.utah.edu
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01233817     History of Changes
Other Study ID Numbers: 39995
First Submitted: October 19, 2010
First Posted: November 3, 2010
Results First Submitted: December 5, 2012
Results First Posted: March 12, 2013
Last Update Posted: June 14, 2017