N/A N=88 Randomized Single-blind Treatment

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

Heart Failure, Diastolic · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT02636439 ↗

Enrolled (actual)

Serious AEs

13.6%

Results posted

Jul 2022

Primary outcome: Primary: Peak Exercise Oxygen Consumption (VO2) — 1609; 1653 ml/min — p=0.21

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: dietary, aerobic and resistance training (Behavioral); dietary, and aerobic exercise (Behavioral)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Peak Exercise Oxygen Consumption (VO2)	1609; 1653	0.21
SECONDARY Skeletal Muscle Mass	49.4; 49.4	0.86
SECONDARY Thigh Skeletal Muscle Mass	108.5; 108.9	0.77
SECONDARY Thigh Muscle Composition	4.0; 4.0	0.85
SECONDARY Muscle Strength	97.5; 103.9	0.053
SECONDARY Muscle Quality	0.90; 0.97	0.043 sig
SECONDARY Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	91; 87	0.07
SECONDARY Quality of Life Measured by Short Form 36 Item Questionnaire (SF-36)	47.4; 46.9	0.79

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).

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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 -

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02636439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.