Exercise Intolerance in Elderly Patients With Diastolic Heart Failure (SECRET)
|ClinicalTrials.gov Identifier: NCT00959660|
Recruitment Status : Completed
First Posted : August 17, 2009
Results First Posted : April 11, 2018
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Diastolic Obesity||Behavioral: Exercise Dietary Supplement: Dietary Intervention Behavioral: Diet and exercise Other: Attention Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual 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|
|Actual Primary Completion Date :||August 15, 2012|
|Actual Study Completion Date :||August 2013|
Active Comparator: Exercise Training
Exercise participants will undergo a 1-hour supervised exercise program 3 times per week for 20 weeks consisting primarily of walking exercise using an individualized exercise prescription based on the initial exercise stress testing results.
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
A hypocaloric diet will be developed to achieve a 2450 kcal/week deficit in addition to undergoing a 1-hour supervised exercise program 3 times per week for 20 weeks consisting primarily of walking exercise using an individualized exercise prescription based on the initial exercise stress testing results.
walking, treadmill and bicycle exerciseBehavioral: Diet and exercise
Subjects will be provided meals and instructions for individual food selections and will undergo walking, treadmill and bicycle exercise.
- Exercise Capacity [ Time Frame: 20 weeks ]Exercise capacity assessed as Peak VO2 (ml/kg/min) via treadmill cardiopulmonary exercise testing using the modified Naughton protocol to the end point of exhaustion.
- Quality of Life [ Time Frame: 20 weeks ]Heart failure-specific quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) on a range 0-100; higher scores indicate better quality of life.
- Body Composition [ Time Frame: 20 weeks ]Total Body Fat Mass and Total Non-bone Lean Mass via DEXA
- Thigh Muscle Composition [ Time Frame: 20 weeks ]Thigh Skeletal Muscle and Subcutaneous Fat via MRI
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|