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Clinical Trials/NCT01233817
NCT01233817CompletedNot Applicable

Pilot Study of Progressive Strength Training in Spinal Muscular Atrophy

University of Utah1 site in 1 country12 target enrollmentStarted: June 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Strength

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
5 Years to 21 Years (Child, Adult)
Sex
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

Arms & Interventions

Spinal muscular atrophy

Experimental

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.

Intervention: Progressive strength training (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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