Overview

This trial is active, not recruiting.

Condition muscular atrophy, spinal
Treatment progressive strength training
Sponsor University of Utah
Start date June 2010
End date June 2013
Trial size 12 participants
Trial identifier NCT01233817, 39995

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
progressive strength training
the systematic increase in resistance weights

Primary Outcomes

Measure
Strength
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 5 years up to 21 years old.

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

Additional Information

Official title Pilot Study of Progressive Strength Training in Spinal Muscular Atrophy
Principal investigator Aga Lewelt, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by University of Utah.