Exercise Intolerance in Elderly Patients With Diastolic Heart Failure (SECRET)
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|ClinicalTrials.gov Identifier: NCT00959660|
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment|
|Heart Failure, Diastolic Obesity||Behavioral: Exercise Dietary Supplement: Dietary Intervention Behavioral: Diet and exercise Other: Attention Control|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Study of the Effect of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction.(SECRET)|
|Actual Study Start Date :||February 2009|
|Primary Completion Date :||August 15, 2012|
|Study Completion Date :||August 2013|
Active Comparator: Exercise Training
Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.
walking, treadmill and bicycle exercise
Active Comparator: Dietary Intervention
A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.
Dietary Supplement: Dietary Intervention
Subjects will be provided meals and instructions for individual food selections.
Active Comparator: Attention control
Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.
Other: Attention Control
control group- continue their previously randomized life style
Active Comparator: Diet and Exercise
The diet and exercise group is a combination of the two groups previously described.
walking, treadmill and bicycle exerciseBehavioral: Diet and exercise
Combination of the exercise and diet group as previously described.
- Exercise capacity [ Time Frame: 20 weeks ]
- Body and thigh muscle composition, Quality of Life [ Time Frame: 20 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959660
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 271757|
|Principal Investigator:||Dalane W Kitzman, MD||Wake Forest University Health Sciences|