Exercise Intolerance in Elderly Patients With HFpEF(Heart Failure With Preserved Ejection Fraction)
SECRET-II
Study of the Effects Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction
2 other identifiers
interventional
88
1 country
1
Brief Summary
The purpose of this study is to examine the effects of weight loss via hypocaloric diet (CR)and aerobic exercise (AT) compared to the effects of weight loss via hypocaloric diet (CR), aerobic training (AT)and resistance training (RT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 9, 2015
CompletedFirst Posted
Study publicly available on registry
December 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2021
CompletedResults Posted
Study results publicly available
July 15, 2022
CompletedJuly 15, 2022
December 1, 2020
6 years
December 9, 2015
June 13, 2022
July 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak Exercise Oxygen Consumption (VO2)
Peak exercise oxygen consumption (VO2) pre and post intervention
20 weeks
Secondary Outcomes (7)
Skeletal Muscle Mass
20 weeks
Thigh Skeletal Muscle Mass
20 weeks
Thigh Muscle Composition
20 weeks
Muscle Strength
20 weeks
Muscle Quality
20 weeks
- +2 more secondary outcomes
Other Outcomes (2)
Mitochondrial Content
20 weeks
Mitochondrial Function
20 weeks
Study Arms (2)
dietary, and aerobic exercise
ACTIVE COMPARATORIntervention for diet-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. Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training.
dietary, aerobic and resistance training
ACTIVE COMPARATORIntervention for diet-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. Intervention for aerobic exercise-Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individual exercise prescription will be developed for aerobic training. Intervention for resistance training- Additional weight resistant exercise will be added to this arm.
Interventions
hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
hypocaloric diet individual prescription for aerobic training.
Eligibility Criteria
You may qualify if:
- Age 60 years or older
- Ejection fraction ≥ 50%
- Left Ventricular Diastolic Dysfunction ≥ grade 1
- BMI ≥ 28 kg/m2
- HF symptoms/ signs by cardiologist review, using NHANES HF Clinical Score \>/= 3 or Rich et al. criteria for HF
You may not qualify if:
- Valvular heart disease as the primary etiology of CHF (congestive heart failure)
- Significant change in cardiac medication or Heart Failure symptoms \<6 weeks
- Hospitalization or urgent care visit \<6 weeks
- Uncontrolled hypertension
- Uncontrolled diabetes
- Evidence of significant Chronic Obstructive Pulmonary Disease (COPD)
- Recent or debilitating stroke
- Cancer or other noncardiovascular conditions with life expectancy less than 2 years
- Significant anemia (\<10 g/dL Hgb)
- Significant renal insufficiency (eGFR \<30 mL/min/1.73m2)
- Pregnant or of child-bearing potential
- Psychiatric disease- uncontrolled major psychoses, depressions, dementia, or personality disorder
- Plans to leave area within the study period
- Refuses informed consent -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Related Publications (2)
Schaich CL, Hughes TM, Kitzman DW, Jung Y, Chen H, Nicklas BJ, Houston DK, Brubaker PH, Molina AJA, Hugenschmidt CE. Neurocognitive Impairments and Their Improvement Following Exercise and Dietary Interventions in Older Patients With Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2024 Jan;17(1):e011134. doi: 10.1161/CIRCHEARTFAILURE.123.011134. Epub 2023 Dec 1. No abstract available.
PMID: 38037817DERIVEDBrubaker PH, Nicklas BJ, Houston DK, Hundley WG, Chen H, Molina AJA, Lyles WM, Nelson B, Upadhya B, Newland R, Kitzman DW. A Randomized, Controlled Trial of Resistance Training Added to Caloric Restriction Plus Aerobic Exercise Training in Obese Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2023 Feb;16(2):e010161. doi: 10.1161/CIRCHEARTFAILURE.122.010161. Epub 2022 Oct 31.
PMID: 36314122DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dalane W. Kitzman, MD
- Organization
- Wake Forest School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Dalane W Kitzman, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2015
First Posted
December 21, 2015
Study Start
August 1, 2015
Primary Completion
July 21, 2021
Study Completion
July 21, 2021
Last Updated
July 15, 2022
Results First Posted
July 15, 2022
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share