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Trial record 27 of 10500 for:    strength

Progressive Strength Training in Spinal Muscular Atrophy

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

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.

Condition or disease Intervention/treatment Phase
Muscular Atrophy, Spinal Other: Progressive strength training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Progressive Strength Training in Spinal Muscular Atrophy
Actual Study Start Date : June 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
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.
Other: Progressive strength training
the systematic increase in resistance weights

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01233817

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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
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Principal Investigator: Aga Lewelt, MD University of Utah

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Responsible Party: University of Utah Identifier: NCT01233817     History of Changes
Other Study ID Numbers: 39995
First Posted: November 3, 2010    Key Record Dates
Results First Posted: March 12, 2013
Last Update Posted: June 14, 2017
Last Verified: May 2017
Keywords provided by University of Utah:
Spinal muscular atrophy
Neuromuscular disorder
Progressive strength training
Additional relevant MeSH terms:
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Muscular Atrophy
Muscular Atrophy, Spinal
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Neuromuscular Diseases