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Original Investigation |

Effect of Caloric Restriction or Aerobic Exercise Training on Peak Oxygen Consumption and Quality of Life in Obese Older Patients With Heart Failure With Preserved Ejection Fraction A Randomized Clinical Trial

Dalane W. Kitzman, MD1; Peter Brubaker, PhD2; Timothy Morgan, PhD3; Mark Haykowsky, PhD4; Gregory Hundley, MD1; William E. Kraus, MD5; Joel Eggebeen, MS6; Barbara J. Nicklas, PhD7
[+] Author Affiliations
1Cardiology Section, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina
2Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina
3Department of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina
4College of Nursing and Health Innovation, University of Texas at Arlington
5Duke University School of Medicine, Durham, North Carolina
6Emory University School of Medicine, Atlanta, Georgia
7Geriatrics and Gerontology Section, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina
JAMA. 2016;315(1):36-46. doi:10.1001/jama.2015.17346.
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Importance  More than 80% of patients with heart failure with preserved ejection fraction (HFPEF), the most common form of heart failure among older persons, are overweight or obese. Exercise intolerance is the primary symptom of chronic HFPEF and a major determinant of reduced quality of life (QOL).

Objective  To determine whether caloric restriction (diet) or aerobic exercise training (exercise) improves exercise capacity and QOL in obese older patients with HFPEF.

Design, Setting, and Participants  Randomized, attention-controlled, 2 × 2 factorial trial conducted from February 2009 through November 2014 in an urban academic medical center. Of 577 initially screened participants, 100 older obese participants (mean [SD]: age, 67 years [5]; body mass index, 39.3 [5.6]) with chronic, stable HFPEF were enrolled (366 excluded by inclusion and exclusion criteria, 31 for other reasons, and 80 declined participation).

Interventions  Twenty weeks of diet, exercise, or both; attention control consisted of telephone calls every 2 weeks.

Main Outcomes and Measures  Exercise capacity measured as peak oxygen consumption (V̇o2, mL/kg/min; co–primary outcome) and QOL measured by the Minnesota Living with Heart Failure (MLHF) Questionnaire (score range: 0–105, higher scores indicate worse heart failure–related QOL; co–primary outcome).

Results  Of the 100 enrolled participants, 26 participants were randomized to exercise; 24 to diet; 25 to exercise + diet; 25 to control. Of these, 92 participants completed the trial. Exercise attendance was 84% (SD, 14%) and diet adherence was 99% (SD, 1%). By main effects analysis, peak V̇o2 was increased significantly by both interventions: exercise, 1.2 mL/kg body mass/min (95% CI, 0.7 to 1.7), P < .001; diet, 1.3 mL/kg body mass/min (95% CI, 0.8 to 1.8), P < .001. The combination of exercise + diet was additive (complementary) for peak V̇o2 (joint effect, 2.5 mL/kg/min). There was no statistically significant change in MLHF total score with exercise and with diet (main effect: exercise, −1 unit [95% CI, −8 to 5], P = .70; diet, −6 units [95% CI, −12 to 1], P = .08). The change in peak V̇o2 was positively correlated with the change in percent lean body mass (r = 0.32; P = .003) and the change in thigh muscle:intermuscular fat ratio (r = 0.27; P = .02). There were no study-related serious adverse events. Body weight decreased by 7% (7 kg [SD, 1]) in the diet group, 3% (4 kg [SD, 1]) in the exercise group, 10% (11 kg [SD, 1] in the exercise + diet group, and 1% (1 kg [SD, 1]) in the control group.

Conclusions and Relevance  Among obese older patients with clinically stable HFPEF, caloric restriction or aerobic exercise training increased peak V̇o2, and the effects may be additive. Neither intervention had a significant effect on quality of life as measured by the MLHF Questionnaire.

Trial Registration  clinicaltrials.gov Identifier: NCT00959660

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Figure 1.
Flow of Participants Through the Study

BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared); COPD, chronic obstructive pulmonary disease; NYHA, New York Heart Association.

aViolated protocol by immediately undertaking formal, aggressive diet and exercise interventions outside of protocol.

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Figure 2.
Adjusted Individual Changes of Primary Study Outcomes From Baseline to 20-Week Follow-up by Factorial Group

MLHF score has a range from 0 to 105; a higher score indicates worse heart failure–related quality of life. The P values represent comparison of least squares means of the outcome measure following adjustment for baseline values, sex, and β-blocker use. The P values in panel A were <.001 for each group (exercise vs no exercise; diet vs no diet); in panel B, .70 for the exercise group vs no exercise group and .08 for the diet group vs no diet group. By factorial group, peak V̇o2 data are missing in 4 cases: 2 in the exercise group (due to gas leak and injury), 1 in the diet group (due to injury), and 1 in the no diet group (due to gas leak). By factorial group, MLHF data are missing in 4 cases: 2 in the diet group, 1 in the exercise group, and 1 in the no exercise group (all due to patient errors). Error bars indicate 95% CI and the horizontal bar indicates the mean.

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