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Interval Training, Inflammation and Immune Function

7. november 2017 oppdatert av: Duke University

The Impact of High Intensity Interval Training on Inflammatory State and Immune Function in Elderly Individuals

PURPOSE: The purpose of this study is to investigate whether High Intensity Interval Training (HIIT)can improve the health and wellbeing of pre-diabetic elderly adults. In particular, there is specific interest in describing the effects of an interval exercise program on inflammatory state and immune function.

DESIGN: Subjects will be sedentary, 65 to 80 years old adults, with prediabetes as defined by fasting plasma glucose (100 to 125 mg/dl). Before and after a 10-12 week High Intensity Interval Exercise training program subjects will undergo several tests including: 1) a maximal treadmill test, 2) an Oral Glucose Tolerance Test, 3) muscle biopsy, 4) body composition, 5) several physical function tests and 6) other health related measures including lung function, arterial stiffness and several blood measures (e.g. liver enzymes, kidney function).

DATA ANALYSES & SAFETY ISSUES: As there are no comparison groups, data analyses will consist of performing paired t-tests on pre and post exercise training values for each of the measurement variables of interest. In addition, the data will be used to provide power calculations for future grant proposals. High Intensity Interval Training is a very safe exercise modality. The regular use of vigorous intensity exercise intervals have been used extensively in exercise training. In fact, the exercise intervals will start at levels lower and will be of shorter duration than were used during the maximal exercise test. They will then be carefully and slowly made to be more challenging as each subject is able to safely tolerate.

HYPOTHESIS: The investigators hypothesize that HIIT will result in significant improvements in markers of inflammation, immune system markers and other health-related risk factors.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • North Carolina
      • Durham, North Carolina, Forente stater, 27705
        • Duke Center for Living

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år til 80 år (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age 65-80 years
  • Prediabetic - Fasting plasma glucose is 100 - 125 on two separate days
  • Able to walk for 2 minutes or more without stopping
  • LDL Cholesterol ≤ 190; Triglycerides < 600;
  • Blood Pressure ≤ 160/90
  • Inactive: Exercise < 2 days per week
  • Medications: Stable use of all medications ≥ three months

Exclusion Criteria:

  • Smoker: tobacco use within the last 12 months
  • Dieting or intending to diet; not weight stable ≥ six months (weight change < 5 pounds)
  • Use of confounding inflammatory medications: aspirin, ibuprofen, naproxen (NSAIDS - nonsteriodal anti-inflammatory drugs)
  • History of diabetes, heart disease or taking medications for those conditions
  • History of hypertension (high blood pressure) not controlled with medication
  • Unwillingness to undergo muscle biopsies and all other study testing, or to continuously participate in exercise training for 12 weeks.
  • Inability to give blood continuously through a catheter (please notify the study nurse of any difficulties you have had in the past when having your blood drawn; the study nurse will determine whether you are excluded for this reason)
  • Unwillingness to conduct ALL exercise sessions at the fitness facility during research study staff supervised times.
  • Orthopedic limitations, musculoskeletal disease and/or injury Due to the nature of the study, persons with known joint, muscle or other orthopedic limitations that restrict physical activity may be excluded.
  • Able to decide if you want to take part in the study
  • Lack of transportation to the exercise and testing facilities

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: HIIT Aging
all subjects will undergo high intensity interval training 3 x per week for 10-12 weeks. the intervals of high-intensity (~85% of maximal capacity) will be 5 to 10 bouts of 30 seconds at this intensity with rest periods in between intervals that range from 30 seconds to 2 minutes
Atferdsmessig: High Intensity Interval training
all subjects will undergo high intensity interval training 3 x per week for 10-12 weeks. the intervals of high-intensity (~85% of maximal capacity) will be 5 to 10 bouts of 30 seconds at this intensity with rest periods in between intervals that range from 30 seconds to 2 minutes

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change in inflammatory markers in plasma
Tidsramme: baseline and following exercise training, approximately 10-12 weeks
baseline and following exercise training, approximately 10-12 weeks
Change in inflammatory markers in muscle
Tidsramme: baseline and following exercise training, approximately 10-12 weeks
baseline and following exercise training, approximately 10-12 weeks
Change in immune markers in peripheral blood
Tidsramme: baseline and following exercise training, approximately 10-12 weeks
baseline and following exercise training, approximately 10-12 weeks
Change in immune markers in muscle
Tidsramme: baseline and following exercise training, approximately 10-12 weeks
baseline and following exercise training, approximately 10-12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Metabolic Syndrome risk factors composite score
Tidsramme: baseline and following exercise training, approximately 10-12 weeks
Classic and additional Metabolic Syndrome measures include: blood pressure, waist circumference, triglycerides, HDL, fasting glucose; plus liver and kidney function, insulin sensitivity, glucose tolerance, etc...
baseline and following exercise training, approximately 10-12 weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Physical Function outcome measures composite score
Tidsramme: baseline and following exercise training, approximately 10-12 weeks
Peak VO2, 400 meter walk time, short physical performance battery (SPPB)
baseline and following exercise training, approximately 10-12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Duke University

Etterforskere

  • Hovedetterforsker: William Kraus, MD, Duke University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2015

Primær fullføring (Faktiske)

14. november 2016

Studiet fullført (Faktiske)

14. november 2016

Datoer for studieregistrering

Først innsendt

9. april 2015

Først innsendt som oppfylte QC-kriteriene

7. mai 2015

Først lagt ut (Anslag)

12. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. november 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • Pro00055208

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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