Exercise Intolerance in Elderly Patients With Diastolic Heart Failure (SECRET)
12 februari 2019 uppdaterad av: Wake Forest University
Study of the Effect of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction.(SECRET)
The purpose of this study is to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with heart failure and a normal ejection fraction (HFNEF) and body mass index greater than or equal to 30.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Heart failure with a normal ejection fraction (HFNEF, previously termed diastolic heart failure), accounts for the majority of heart failure cases in the population > 65 years old and has been recognized as a true geriatric syndrome.
Exercise intolerance is the primary chronic symptom of HFNEF and a major determinant of these patients' severely reduced quality of life; however little is known regarding its pathophysiology and treatment.
Therefore, our work has focused on understanding the pathophysiology of exercise intolerance in HFNEF and developing and testing interventions that may improve this pivotal outcome in this highly prevalent disorder of older persons.
The aims of the proposed study are to conduct a randomized, controlled, single-blinded, 2x2 design trial to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with HFNEF and body mass index >30 in order to test the following hypotheses: 1) Both weight loss and exercise training will improve exercise intolerance and quality of life in older, obese patients with HFNEF; 2) The combination of weight loss and exercise training will produce complementary effects on body and thigh muscle composition and additive improvements in exercise intolerance in HFNEF; 3) Improvements in exercise intolerance will correlate with improvements in lean body mass, reversal of adverse thigh muscle remodeling, and increased thigh muscle capillarity.
The study has the potential to significantly advance our understanding of exercise intolerance and its treatment in the large population of older persons with HFNEF.
Studietyp
Interventionell
Inskrivning (Faktisk)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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North Carolina
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Winston-Salem, North Carolina, Förenta staterna, 271757
- Wake Forest University Health Sciences
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
60 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Heart failure clinical score greater than or equal to 3
- Age 60 and over
- Normal ejection fraction greater than or equal to 50%
- BMI greater than or equal to 30
Exclusion Criteria:
- Valvular heart disease
- Significant change in cardiac medication <4 weeks
- Uncontrolled hypertension
- Recent or debilitating stroke
- Cancer or other noncardiovascular conditions with life expectancy less than 2 years
- Significant Anemia
- Renal insufficiency (creatinine >2.5mg/dl)
- Psychiatric disease- uncontrolled major psychoses, depressions, dementia, or personality disorder
- Plans to leave area within 6 months
- Refuses informed consent
- Failure to pass screening test:pulmonary function, echocardiogram,or exercise
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
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walking, treadmill and bicycle exercise
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Aktiv komparator: 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.
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Subjects will be provided meals and instructions for individual food selections.
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Aktiv komparator: 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.
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control group- continue their previously randomized life style
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Aktiv komparator: 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.
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walking, treadmill and bicycle exercise
Subjects will be provided meals and instructions for individual food selections and will undergo walking, treadmill and bicycle exercise.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Exercise Capacity
Tidsram: 20 weeks
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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.
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20 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Quality of Life
Tidsram: 20 weeks
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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.
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20 weeks
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Body Composition
Tidsram: 20 weeks
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Total Body Fat Mass and Total Non-bone Lean Mass via DEXA
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20 weeks
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Thigh Muscle Composition
Tidsram: 20 weeks
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Thigh Skeletal Muscle and Subcutaneous Fat via MRI
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20 weeks
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Samarbetspartners och utredare
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Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Singleton MJ, Nelson MB, Samuel TJ, Kitzman DW, Brubaker P, Haykowsky MJ, Upadhya B, Chen H, Nelson MD. Left Atrial Stiffness Index Independently Predicts Exercise Intolerance and Quality of Life in Older, Obese Patients With Heart Failure With Preserved Ejection Fraction. J Card Fail. 2022 Apr;28(4):567-575. doi: 10.1016/j.cardfail.2021.10.010. Epub 2021 Nov 10.
- Anderson T, Cascino TM, Koelling TM, Perry D, Grafton G, Houston DK, Upadhya B, Kitzman DW, Hummel SL. Measured Versus Estimated Resting Metabolic Rate in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2021 Aug;14(8):e007962. doi: 10.1161/CIRCHEARTFAILURE.120.007962. Epub 2021 Aug 4.
- Haykowsky MJ, Nicklas BJ, Brubaker PH, Hundley WG, Brinkley TE, Upadhya B, Becton JT, Nelson MD, Chen H, Kitzman DW. Regional Adipose Distribution and its Relationship to Exercise Intolerance in Older Obese Patients Who Have Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2018 Aug;6(8):640-649. doi: 10.1016/j.jchf.2018.06.002. Epub 2018 Jul 11.
- Maldonado-Martin S, Brubaker PH, Eggebeen J, Stewart KP, Kitzman DW. Association Between 6-Minute Walk Test Distance and Objective Variables of Functional Capacity After Exercise Training in Elderly Heart Failure Patients With Preserved Ejection Fraction: A Randomized Exercise Trial. Arch Phys Med Rehabil. 2017 Mar;98(3):600-603. doi: 10.1016/j.apmr.2016.08.481. Epub 2016 Sep 28.
- Kitzman DW, Brubaker P, Morgan T, Haykowsky M, Hundley G, Kraus WE, Eggebeen J, Nicklas BJ. 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. JAMA. 2016 Jan 5;315(1):36-46. doi: 10.1001/jama.2015.17346.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2009
Primärt slutförande (Faktisk)
15 augusti 2012
Avslutad studie (Faktisk)
1 augusti 2013
Studieregistreringsdatum
Först inskickad
14 augusti 2009
Först inskickad som uppfyllde QC-kriterierna
14 augusti 2009
Första postat (Uppskatta)
17 augusti 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 februari 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 februari 2019
Senast verifierad
1 februari 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00005668
- R37AG018915 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
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