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Trial record 17 of 398 for:    Recruiting, Not yet recruiting, Available Studies | wake forest

Exercise Intolerance in Elderly Patients With HFpEF(Heart Failure With Preserved Ejection Fraction) (SECRET-II)

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ClinicalTrials.gov Identifier: NCT02636439
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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).

Condition or disease Intervention/treatment Phase
Heart Failure, Diastolic Obesity Behavioral: dietary, aerobic and resistance training Behavioral: dietary, and aerobic exercise Not Applicable

Detailed Description:

Heart failure with preserved ejection fraction (HFPEF) is the most common form of HF, is nearly unique to the older population, particularly older women, and is increasing in prevalence. Exercise intolerance, with severe exertional dyspnea and fatigue, is the primary manifestation of chronic HFPEF and is a major determinant of these patients' severely reduced quality of life (QOL). However, its pathophysiology is poorly understood and its optimal treatment remains undefined.

Our recent data and others' indicate that in older HFPEF patients, both increased adiposity and abnormalities in skeletal muscle are major contributors to exercise intolerance and potential therapeutic targets. Obesity is one of the strongest risk factors for HFPEF, and is a robust predictor of physical disability in older persons. The investigator recently reported that in HFPEF compared to age-matched controls, percent total and leg lean mass are significantly reduced and independently predict exercise capacity.

Using MRI and needle biopsy of the thigh muscle, the investigators found increased fat infiltration, reduced capillary density and percent type I oxidative fibers, and trends for reduced muscle mitochondrial mass and function. Reduced exercise capacity was related to each of these muscle abnormalities, supporting their important role in HFPEF.

Diet, with or without aerobic exercise, can increase exercise capacity and quality of life in older obese persons with a variety of disorders, but usually results in significant loss of skeletal muscle mass, which could potentially have adverse long term consequences. The purpose of this trial is to determine if addition of resistance training to diet plus aerobic exercise training can improve skeletal muscle mass and function in HFPEF.

Multiple lines of evidence and our preliminary data indicate that resistance training (RT) may be an ideal addition to CR+AT for HFPEF, since RT reliably increases muscle mass, quality, strength, and function, significantly more than AT, and can prevent nearly 50% of the muscle mass loss during CR.

Therefore, the primary aim of the proposed study is to conduct a randomized, single-blinded 20-week intervention trial of RT added to CR+AT in 84 overweight / obese (BMI greater than 28 kg/m2), older (age greater than 60 years) HFPEF patients to test the following primary hypothesis:

The addition of resistance training to CR+AT will improve exercise capacity.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Effects Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction
Actual Study Start Date : August 2015
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: dietary, and aerobic exercise

Intervention 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.

Behavioral: dietary, and aerobic exercise
hypocaloric diet individual prescription for aerobic training.

Active Comparator: dietary, aerobic and resistance training

Intervention 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.

Behavioral: dietary, aerobic and resistance training
hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.

Behavioral: dietary, and aerobic exercise
hypocaloric diet individual prescription for aerobic training.




Primary Outcome Measures :
  1. Peak exercise oxygen consumption (VO2) [ Time Frame: 20 weeks ]
    Peak exercise oxygen consumption (VO2) pre and post intervention


Secondary Outcome Measures :
  1. Skeletal muscle mass [ Time Frame: 20 weeks ]
    Measure skeletal muscle mass in kg by DEXA and MRI analysis pre and post intervention.

  2. Mitochondrial content [ Time Frame: 20 weeks ]
    Porin citrate synthase pre and post intervention.

  3. Mitochondrial function [ Time Frame: 20 weeks ]
    respiratory control ratio and mitofusin 2 concentration.pre and post intervention.

  4. Quality of life [ Time Frame: 20 weeks ]
    KCCQ (Kansas City Cardiomyopathy Questionnaire) and SF36 pre and post intervention.

  5. Muscle strength [ Time Frame: 20 weeks ]
    maximal isokinetic knee extensor strength (Newton-meters, Nm) and power (Watts) in both legs using an isokinetic dynamometer (Biodex®)

  6. Muscle quality [ Time Frame: 20 weeks ]
    knee extensor strength to thigh muscle area assessed by MRI (Nm/cm2) and leg lean mass assessed by DXA (Nm/kg lean mass).

  7. Thigh muscle composition [ Time Frame: 20 weeks ]
    MRI skeletal muscle to intermuscular fat ratio



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 60 years or older
  2. Ejection fraction ≥ 50%
  3. Left Ventricular Diastolic Dysfunction ≥ grade 1
  4. BMI ≥ 28 kg/m2
  5. HF symptoms/ signs by cardiologist review, using NHANES HF Clinical Score >/= 3 or Rich et al. criteria for HF

Exclusion Criteria:

  1. Valvular heart disease as the primary etiology of CHF (congestive heart failure)
  2. Significant change in cardiac medication or Heart Failure symptoms <6 weeks
  3. Hospitalization or urgent care visit <6 weeks
  4. Uncontrolled hypertension
  5. Uncontrolled diabetes
  6. Evidence of significant Chronic Obstructive Pulmonary Disease (COPD)
  7. Recent or debilitating stroke
  8. Cancer or other noncardiovascular conditions with life expectancy less than 2 years
  9. Significant anemia (<10 g/dL Hgb)
  10. Significant renal insufficiency (eGFR <30 mL/min/1.73m2)
  11. Pregnant or of child-bearing potential
  12. Psychiatric disease- uncontrolled major psychoses, depressions, dementia, or personality disorder
  13. Plans to leave area within the study period
  14. Refuses informed consent -

Information from the National Library of Medicine

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): NCT02636439


Contacts
Contact: Dalane W Kitzman, MD 336-716-3274 dkitzman@wakehealth.edu
Contact: Kathryn P Stewart, AASRT, RDCS 336-716-6339 kstewart@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Kathy P Stewart, RDCS    336-716-6339    kstewart@wakehealth.edu   
Contact: Thomas D Becton, MS    336-716-6967    jbecton@wakehealth.edu   
Principal Investigator: Dalane W Kitzman, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute on Aging (NIA)
Investigators
Principal Investigator: Dalane W Kitzman, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02636439     History of Changes
Other Study ID Numbers: IRB00032364
R01AG018915 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Diastolic heart failure
Heart Failure
Elderly
Obesity

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases