Diet and Exercise in Pompe Disease
Completed · Not applicable
Conditions studied: Pompe Disease, Glycogen Storage Disease Type II, Lysosomal Storage Diseases
In brief
This study examines the effects of individualized diet and exercise plans on muscle strength, quality of life and respiratory function in Pompe disease. Subjects will be given a diet and exercise plan based on their individual needs, which will be followed for 16 weeks. Participants will also be provided with an activity tracker in order to track their exercise activities, access to an app that will allow them to input their daily food intake, and they will also come to the University of Florida for exercise tests, respiratory tests and questionnaires.
Key facts
- Study ID
- NCT02363153
- Run by
- University of Florida
- People needed
- 2
- Starts
- 2017-11-06
- Expected to finish
- 2021-05-12
- Last updated by the study team
- 2021-05-14
Who can join
Age: 15 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female subjects 15-55 years of age;
- Have a diagnosis of Pompe disease, as defined by protein assay and/or DNA sequence of the acid alpha-glucosidase gene, with present clinical symptoms of the disease;
- Be naïve to ERT or receiving ERT for at least eighteen months prior to beginning study;
- Be able to walk at least 40m in the 6 minute walk test.
- Willing to comply with study requirements
You may not qualify if…
- Be pregnant;
- Be in the lower limit for pulmonary function; FVC < 30% predicted;
- Be dependent on assisted ventilation;
- Be dependent on wheelchair;
- Have evidence of clinical heart failure;
- Have any contraindication to exercise
Where it is running
- University of Florida Clinical Research Center — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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