Exercise Training in Barth Syndrome
Safety and Efficacy of Aerobic Exercise Training in Barth Syndrome
1 other identifier
interventional
4
0 countries
N/A
Brief Summary
Barth syndrome (BTHS) is a genetic disease that results in heart failure, muscle weakness and exercise intolerance. Several studies in non-BTHS heart failure suggest that endurance exercise training is beneficial in improving exercise intolerance, heart function and quality of life in young men with BTHS. This study will examine the effects of Endurance (i.e. aerobic) exercise training on exercise tolerance, heart function, and quality of life in adolescents and young adults with BTHS. We hypothesize that 3 months of endurance training will improve exercise tolerance, heart function and quality of life in adolescents and young men with BTHS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2010
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 30, 2010
CompletedFirst Posted
Study publicly available on registry
September 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 10, 2017
January 1, 2017
3.4 years
August 30, 2010
January 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak oxygen consumption
peak oxygen consumption measured by indirect calorimetry
Enrollment and 3 months
Secondary Outcomes (2)
Cardiac output
Enrollment and 3 months
muscle oxygen extraction
Enrollment and 3 months
Study Arms (1)
Exercise training
EXPERIMENTALAerobic exercise training 45-60 min/3x/week/12 weeks
Interventions
aerobic exercise training, 45-60 minutes, 3x/week, 12 weeks (3-months)
Eligibility Criteria
You may qualify if:
- Age 15-30 years
- Sedentary (exercises less than 2x/wk)
- Motivated to exercise
- Stable on medications for ≥ 3 months
- Lives in North America.
- Planning on attending the Barth Syndrome International Conference in July 2010.
You may not qualify if:
- Unstable heart disease
- Any concurrent disease that may contraindicate exercise testing and training.
- Cardiac transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Cade WT, Reeds DN, Peterson LR, Bohnert KL, Tinius RA, Benni PB, Byrne BJ, Taylor CL. Endurance Exercise Training in Young Adults with Barth Syndrome: A Pilot Study. JIMD Rep. 2017;32:15-24. doi: 10.1007/8904_2016_553. Epub 2016 Jun 11.
PMID: 27295193RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William T Cade, PT, PhD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisant Professor of Physical Therapy and Medicine
Study Record Dates
First Submitted
August 30, 2010
First Posted
September 2, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 10, 2017
Record last verified: 2017-01