Resistance Exercise in Barth Syndrome
Effects of Resistance Exercise Training on Cardiac, Metabolic and Muscle Function and Quality of Life in Barth Syndrome
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 15-35 years
- Sedentary (exercises less than 2x/wk)
- Motivated to exercise (BTHS only)
- Stable on medications for ≥ 3 months (BTHS only)
- Lives in North America
- Lives in the St. Louis area (Controls only)
Exclusion Criteria:
- Unstable heart disease
- Cardiac transplantation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Resistance exercise training
Participants will undergo resistance exercise training 3x/wk for 12 weeks at a physical therapy or cardiac rehabilitation facility near the participant's home.
|
Resistance exercise training will occur 3x/wk for 12 wks at a physical therapy or cardiac rehabilitation facility near the participant's home.
Participant will take 42 grams of supplementation protein daily.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in exercise tolerance
Time Frame: Enrollment, 3 months
|
This study will examine the effect of resistance exercise training on exercise tolerance: peak oxygen consumption, exercise time and exercise work during graded exercise test on cycle ergometer
|
Enrollment, 3 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in muscle strength
Time Frame: Enrollment, 3 months
|
This study will measure the effect of resistance exercise training on muscle strength measured by 1-repetition maxium testing on universal equipment
|
Enrollment, 3 months
|
|
Change in quality of life
Time Frame: Enrollment, 3 months
|
This study will examine the effect of resistance exercise training on quality of life measures by Minnesota living with heart failure questionnaire
|
Enrollment, 3 months
|
|
Change in left ventricular systolic strain
Time Frame: Enrollment, 3 months
|
This study will examine the effect of resistance exercise training on left ventricular systolic strain measured by tissue Doppler echocardiography
|
Enrollment, 3 months
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Disease
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Metabolism, Inborn Errors
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Abnormalities, Multiple
- Lipid Metabolism, Inborn Errors
- Syndrome
- Barth Syndrome
Other Study ID Numbers
Other Study ID Numbers
- 201205024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.