Progressive Strength Training in Spinal Muscular Atrophy

Muscular Atrophy, Spinal Clinical Trial

Official title:

Pilot Study of Progressive Strength Training in Spinal Muscular Atrophy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01233817
• Other study ID #: 39995
• Status: Active, not recruiting
• Phase: N/A
• First received: October 19, 2010
• Last updated: February 5, 2013
• Start date: June 2010

Study information

• Verified date: February 2013
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 21 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Muscular Atrophy
• Muscular Atrophy, Spinal

Intervention

Other:
• Progressive strength training
the systematic increase in resistance weights

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	Yes