Lifestyle Intervention Trial in Obese Elderly (LITOE)
17. januar 2020 opdateret af: Dennis Villareal, Biomedical Research Institute of New Mexico
Exercise Interventions During Voluntary Weight Loss in Obese Older Adults
Obesity causes frailty in obese older adults by exacerbating the age-related decline in physical function.
However, appropriate management of obesity in older adults is controversial.
Weight loss without exercise could worsen frailty by accelerating the usual age-related decline in muscle and bone mass that leads to sarcopenia and osteopenia, respectively.
Because of the important problem of frailty in obese older adults, it is important to determine the most efficacious approach in reducing, or even reversing frailty in this population.
The primary objective of this proposal is to evaluate which distinct type of physical exercise (resistance, aerobic, or combined resistance + aerobic) is most efficacious in preventing the weight-loss-induced reduction in muscle and bone mass and reversing frailty in obese older adults.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
160
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87108
- New Mexico VA Medical Center and University of New Mexico School of Medicine
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Texas
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år til 85 år (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 65-85 years old
- Obese men and women (BMI > or equal to 30 kg/m2)
- Stable weight (±2 kg) during the last 6 mos.
- Must be sedentary (regular exercise <1 h/wk or <2 x/wk for the last 6 mos.)
- Be judged, during the initial screening, to be well motivated and reliable
Exclusion Criteria:
- Any major chronic diseases
- Any condition or unstable diseases that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results that include but are not limited to:
- Cardiopulmonary disease (e.g., recent MI, unstable angina, stroke etc.)
- Severe orthopedic/musculoskeletal or neuromuscular impairments that would contraindicate participation in exercise
- Visual or hearing impairments that interfere with following directions
- Diagnosis of dementia
- History of malignancy during the past 5 yr
- Recent use of bone acting drugs (e.g. use of estrogen, or androgen containing compound, raloxifene, calcitonin, parathyroid hormone during the past year or biphosphonates during the last two years)
- Individuals on insulin or with a fasting blood glucose of > 140mg/dl, and/or a 2 hour post-glucose of >250 mg/dl
- BMD t-scores of <-2.3 of the lumbar spine and proximal femur
- serum creatinine >2.0 mg/dl
- No commitments, life situations or conditions that would interfere with their participation in the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Diet + Resistance Exercise Training
Weekly behavioral/diet-induced weight loss plus supervised resistance exercise training three times a week
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Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and resistance exercise training 3-days/week for 24 weeks.
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Eksperimentel: Diet + Aerobic Exercise Training
Weekly behavioral/diet-induced weight loss plus supervised aerobic exercise training three times a week
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Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and aerobic exercise training 3-days/week for 24 weeks
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Eksperimentel: Diet + Combined Aerobic/Resistance Exercise
Weekly behavioral/diet-induced weight loss plus combined supervised resistance exercise training and aerobic exercise training three times a week
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Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and combined resistance/aerobic exercise training 3-days/week for 24 weeks
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Ingen indgriben: Control Group (No Diet/No Exercise)
No diet No exercise training
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Physical Function
Tidsramme: 6 Months
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The Physical Performance Test includes seven standardized tasks (walking 15.2 m [50 ft], putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg test) plus two additional tasks (going up and down four flights of stairs and making a 360-degree turn).
The score for each task ranges from 0 to 4, with higher scores indicating better physical performance; a perfect score would be 36.
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6 Months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ændring i dynamisk balance
Tidsramme: 6 måneder
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Vurderet af forhindringsbanen
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6 måneder
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Ændring i statisk balance
Tidsramme: 6 måneder
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Vurderet ved et benstilling
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6 måneder
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Ændring i subjektiv evne til at fungere
Tidsramme: 6 måneder
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Vurderet af Spørgeskema for funktionel status (scoreinterval: 0 til 36 med højere score, der indikerer bedre funktion)
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6 måneder
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Ændring i humør
Tidsramme: 6 måneder
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Vurderet ved geriatrisk depressionsskala (scoreområde: 0 til 30, hvor lavere score indikerer bedre humør)
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6 måneder
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Ændring i medicinske resultater 36-item kort formular Sundhedsundersøgelse (SF-36)
Tidsramme: 6 måneder
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Vurderet ved fysisk komponentresumé og mental komponentresuméscore (scoreområde 0 til 100, med højere score, der indikerer bedre sundhedsstatus)
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6 måneder
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Ændring i vægtens indflydelse på livskvalitet_Lite (IWQOL-lite) score
Tidsramme: 6 måneder
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Vurderet af IWQO-liteL spørgeskema
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6 måneder
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Ændring i serumlipider
Tidsramme: 6 måneder
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Vurderet ved automatiserede enzymatiske/kolorimetriske analyser
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6 måneder
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Ændring i sædvanlig fysisk aktivitet vurderet ved spørgeskemaer
Tidsramme: 6 måneder
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Brug af Stanford-spørgeskemaet til fysisk aktivitet (scoreinterval: 0 til 40 med højere score, der indikerer højere fysiske aktivitetsniveauer)
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6 måneder
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Ændring i sædvanlig fysisk aktivitet målt objektivt
Tidsramme: 6 måneder
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Brug af accelerometre
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6 måneder
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Change in lean mass
Tidsramme: 6 months
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Assessed using dual energy x-ray absorptiometry (DXA)
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6 months
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Change in fat mass
Tidsramme: 6 months
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Assessed using DXA
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6 months
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Change in muscle strength
Tidsramme: 6 months
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Assessed using 1-repetition maximum and dynamometry
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6 months
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Change in gait speed
Tidsramme: 6 months
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Measured as time to walk a certain distance
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6 months
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Change in areal bone mineral density
Tidsramme: 6 months
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Assessed by using DXA
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6 months
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Change in biochemical marker for bone turnover and bone metabolism
Tidsramme: 6 months
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Assessed by using enzyme linked immunoabsorbent assay and radioimmunoassay
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6 months
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Change in circulating cytokines
Tidsramme: 6 months
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Assessed by using enzyme linked immunoassay
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6 months
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Change in adipocytokines
Tidsramme: 6 months
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Assessed by using enzyme linked immunoassay
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6 months
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Change in aerobic capacity
Tidsramme: 6 months
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Assessed by using indirect calorimetry during graded exercise stress test
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6 months
|
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Change in systolic and diastolic blood pressure
Tidsramme: 6 months
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Assessed by using sphygmomanometer
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6 months
|
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Change in serum glucose
Tidsramme: 6 months
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Assessed by glucose oxidase method
|
6 months
|
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Change in serum insulin
Tidsramme: 6 months
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Assessed by immunoassay
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6 months
|
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Change in serum estradiol
Tidsramme: 6 months
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Assessed by immunoassay
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6 months
|
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Change in 25 hydroxyvitamin D
Tidsramme: 6 months
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Assessed by immunoassay
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6 months
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Change in gene expression of muscle anabolic and catabolic factors
Tidsramme: 6 months
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Assessed by reverse transcription polymerase chain reaction and nanostring
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6 months
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Change in protein expression of muscle anabolic and catabolic factors
Tidsramme: 6 months
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Assessed by western blotting
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6 months
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Change in concentration of targeted metabolites
Tidsramme: 6 months
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Assessed by liquid chromatography hyphenated with mass spectrometry techniques
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6 months
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Change in modified mini-mental exam
Tidsramme: 6 months
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Assessed by using cognitive instrument testing
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6 months
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Change in word fluency
Tidsramme: 6 months
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Assessed by using cognitive instrument testing
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6 months
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Change in trail a and trail b
Tidsramme: 6 months
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Assessed by using cognitive instrument testing
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6 months
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Change in Ray Auditory verbal learning test
Tidsramme: 6 months
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Assessed by using cognitive instrument testing
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6 months
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Change in muscle protein synthesis rate
Tidsramme: 6 months
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Assessed by stable isotope methodology
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6 months
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Change in thigh muscle and fat mass
Tidsramme: 6 months
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Assessed by magnetic resonance imaging (MRI)
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6 months
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Change in visceral fat mass
Tidsramme: 6 months
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Assessed by MRI
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6 months
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Change in waist circumference
Tidsramme: 6 months
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Using a tape measure
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6 months
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Change in serum testosterone
Tidsramme: 6 months
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Assessed by immunoassay
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6 months
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Change is serum sclerostin
Tidsramme: 6 months
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Assessed by immunoassay
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6 months
|
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Change in parathyroid hormone
Tidsramme: 6 months
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Assessed by immunoassay
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Dennis T Villareal, MD FACP FACE, Baylor College of Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Armamento-Villareal R, Aguirre L, Waters DL, Napoli N, Qualls C, Villareal DT. Effect of Aerobic or Resistance Exercise, or Both, on Bone Mineral Density and Bone Metabolism in Obese Older Adults While Dieting: A Randomized Controlled Trial. J Bone Miner Res. 2020 Mar;35(3):430-439. doi: 10.1002/jbmr.3905. Epub 2019 Dec 4.
- Colleluori G, Aguirre L, Phadnis U, Fowler K, Armamento-Villareal R, Sun Z, Brunetti L, Hyoung Park J, Kaipparettu BA, Putluri N, Auetumrongsawat V, Yarasheski K, Qualls C, Villareal DT. Aerobic Plus Resistance Exercise in Obese Older Adults Improves Muscle Protein Synthesis and Preserves Myocellular Quality Despite Weight Loss. Cell Metab. 2019 Aug 6;30(2):261-273.e6. doi: 10.1016/j.cmet.2019.06.008. Epub 2019 Jul 3.
- Villareal DT, Aguirre L, Gurney AB, Waters DL, Sinacore DR, Colombo E, Armamento-Villareal R, Qualls C. Aerobic or Resistance Exercise, or Both, in Dieting Obese Older Adults. N Engl J Med. 2017 May 18;376(20):1943-1955. doi: 10.1056/NEJMoa1616338.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2010
Primær færdiggørelse (Faktiske)
1. januar 2016
Studieafslutning (Faktiske)
31. december 2018
Datoer for studieregistrering
Først indsendt
8. februar 2010
Først indsendt, der opfyldte QC-kriterier
8. februar 2010
Først opslået (Skøn)
9. februar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- R01AG031176 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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