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Progressive Strength Training in Spinal Muscular Atrophy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01233817
First received: October 19, 2010
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Progressive Strength Training in Spinal Muscular Atrophy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Strength [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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
Study Start Date: June 2010
Estimated 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

Ages Eligible for Study:   5 Years to 21 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01233817     History of Changes
Other Study ID Numbers: 39995
Study First Received: October 19, 2010
Results First Received: December 5, 2012
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013