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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
  Purpose
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 Intervention
Muscular Atrophy, Spinal Other: Progressive strength training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Progressive Strength Training in Spinal Muscular Atrophy

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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.


Enrollment: 12
Actual Study Start Date: June 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01233817


Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Aga Lewelt, MD University of Utah
  More 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
Last Verified: May 2017

Keywords provided by University of Utah:
Spinal muscular atrophy
Neuromuscular disorder
Progressive strength training
Children

Additional relevant MeSH terms:
Atrophy
Muscular Atrophy
Muscular Atrophy, Spinal
Spinal Cord Diseases
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Neuromuscular Diseases