- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01233817
Progressive Strength Training in Spinal Muscular Atrophy
May 15, 2017 updated by: University of Utah
Pilot Study of Progressive Strength Training in Spinal Muscular Atrophy
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- University of Utah
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
the systematic increase in resistance weights
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aga Lewelt, MD, University of Utah
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2010
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
October 19, 2010
First Submitted That Met QC Criteria
November 1, 2010
First Posted (Estimate)
November 3, 2010
Study Record Updates
Last Update Posted (Actual)
June 14, 2017
Last Update Submitted That Met QC Criteria
May 15, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 39995
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Muscular Atrophy, Spinal
-
Marco CapogrossoRoche-GenentechRecruitingSpinal Muscular Atrophy Type 3 | Spinal Muscular Atrophy Type 4United States
-
Institut de Myologie, FranceInstitut RocheCompletedType 2 Spinal Muscular Atrophy | Type 3 Spinal Muscular AtrophyBelgium, France, Germany
-
Marco CapogrossoRoche-GenentechNot yet recruitingSpinal Muscular Atrophy | Spinal Muscular Atrophy Type 3 | SMA | Spinal Muscular Atrophy Type II | Spinal Muscular Atrophy 4United States
-
Novartis Gene TherapiesActive, not recruitingSMA | Spinal Muscular Atrophy Type II | Spinal Muscular Atrophy Type I | Spinal Muscular Atrophy Type IIIUnited States, Belgium, France, Japan, United Kingdom, Italy, Taiwan, Australia, Canada
-
Hoffmann-La RocheRecruitingSpinal Muscular Atrophy (SMA)Belgium, United States, Croatia, Japan, Netherlands, Spain, Canada, Poland, United Kingdom, Italy, Portugal, Australia
-
Northwell HealthCompletedAdult Spinal Muscular AtrophyUnited States
-
Hugh McMillanFamilies of Spinal Muscular Atrophy; Gwendolyn Strong FoundationTerminatedSpinal Muscular Atrophy (SMA)Canada
-
AveXis, Inc.United BioSource, LLCRecruitingSpinal Muscular Atrophy (SMA)Japan, United States, Korea, Republic of, Israel, Greece, Ireland, Portugal, Russian Federation, Taiwan
-
Hoffmann-La RocheAssociation Française contre les Myopathies (AFM), ParisCompletedSpinal Muscular Atrophy Type II | Spinal Muscular Atrophy Type III Non AmbulantGermany, Italy, France, Belgium, Poland, Netherlands, United Kingdom
-
Istanbul Medipol University HospitalIstanbul UniversityRecruitingNeuromuscular Diseases | Spinal Muscular Atrophy Type 3Turkey
Clinical Trials on Progressive strength training
-
Universitaire Ziekenhuizen KU LeuvenKU Leuven; Queen Fabiola Children's University Hospital; University GhentCompletedCerebral Palsy, SpasticBelgium
-
Glostrup University Hospital, CopenhagenCompletedNeurological Diseases | Medical Diseases | Chronical Obstructive Lung DiseasesDenmark
-
Hugo W. Moser Research Institute at Kennedy Krieger...National Multiple Sclerosis SocietyCompletedMultiple SclerosisUnited States
-
Oslo University HospitalCompletedCerebral Palsy, Spastic, DiplegicNorway
-
Sikkim Manipal UniversityUnknown
-
Inland Norway University of Applied SciencesSykehuset Innlandet HF; Revmatismesykehuset ASCompleted
-
Hacettepe UniversityCompletedSpastic Hemiplegic Cerebral PalsyTurkey
-
German Cancer Research CenterHeidelberg University; Technical University of MunichWithdrawn
-
University of Southern DenmarkOdense University Hospital; Aalborg University Hospital; Sygehus Lillebaelt; Region...Completed
-
German Cancer Research CenterCompletedAll Tumor Entities Treated With TKI TherapyGermany