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Cardio Training of Older Adults With Central Obesity

28. februar 2018 opdateret af: Anna Nordström, Region Västerbotten
Given the increasing prevalence of obesity, there is an urgent need to find better strategies to promote physical activity in the community. The present study will invite 70-year-olds with central (abdominal) obesity to participate in a 10-week aerobic exercise program. Participants will be randomly assigned to one of two equally large groups. The first group will complete the exercise program in instructor-led groups. The second group will complete the program at home with the help of an on-line video.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

Central obesity means having a lot visceral fat, that is, fat located in the abdominal cavity. Visceral fat is a well-established risk factor for cardiovascular disease and all-cause mortality.

Participants will be recruited from the Healthy Ageing Initiative (HAI), an ongoing population-based study that invites all 70-year-olds in Umeå, Sweden, to a health examination. The exercise program will focus is on station-based aerobic exercises and resistance exercises, predominantly with participants' own body weight as resistance. The program is progressive, starting at a moderate pace so that participants learn to perform the exercises properly. The intensity will be aimed at 60-80% of maximal exhaustion, and each exercise bout will last 60 seconds with 20 seconds of rest between bouts. The program was developed by seniors in the bachelor's program in exercise physiology at Umeå University, Sweden.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Västerbotten
      • Umeå, Västerbotten, Sverige, 907 36
        • Livsmedicin (LIFE)

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

70 år til 70 år (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participated in the Healthy Ageing Initiative (a population-based intervention study in Umeå, Sweden)
  • Visceral adipose tissue mass >1 kg (women) or >2 kg (men)

Exclusion Criteria:

  • Physical disability that affects ability to perform the exercises
  • Heart failure or severe degenerative condition (e.g. malignant cancer or multiple sclerosis)
  • Myocardial infarction or stroke in the past year
  • Heart condition that can worsen with aerobic exercise (e.g. angina)

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
Eksperimentel: Intervention Group
Weeks 1-10: exercise program in group. Weeks 11-20: no intervention. Weeks 21-31: no intervention.
An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.
Eksperimentel: Control group
Weeks 1-10: no intervention. Weeks 11-20: no intervention. Weeks 21-31: exercise program at home.
An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in visceral adipose tissue mass
Tidsramme: 0, 10, 20, and 31 weeks
Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA).
0, 10, 20, and 31 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in body composition
Tidsramme: 0, 10, 20, and 31 weeks
Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA)
0, 10, 20, and 31 weeks
Change in Body Mass Index (kg/m^2)
Tidsramme: 0, 10, 20, and 31 weeks
0, 10, 20, and 31 weeks
Change in blood pressure (mmHg)
Tidsramme: 0, 10, 20, and 31 weeks
Taken after 15 min of rest
0, 10, 20, and 31 weeks
Change in blood-lipid profile
Tidsramme: 0, 10, 20, and 31 weeks
0, 10, 20, and 31 weeks
Change in fasting blood glucose
Tidsramme: 0, 10, 20, and 31 weeks
Veinous blood samples taken after > 4 h of fasting
0, 10, 20, and 31 weeks
Change in isometric muscle strength
Tidsramme: 0, 10, 20, and 31 weeks
Measured in non-dominant hand with dynamometer (Jamar, Lafayette Instrument, USA). The better of two successive trials will be recorded.
0, 10, 20, and 31 weeks
Change in physical capacity
Tidsramme: 0, 10, 20, and 31 weeks
Measured using Åstrands Submaximal Test, performed on an electrically braked ergometer bicycle
0, 10, 20, and 31 weeks
Change in resting metabolic rate
Tidsramme: 0, 10, 20, and 31 weeks
As measured by indirect calorimetry
0, 10, 20, and 31 weeks
Change in health-related quality of life
Tidsramme: 0, 10, 20, and 31 weeks
As measured by RAND-36
0, 10, 20, and 31 weeks
Change in self-reported physical activity
Tidsramme: 0, 10, 20, and 31 weeks
Assessed using IPAQ-SF
0, 10, 20, and 31 weeks
Change in Microbiota composition
Tidsramme: 0, 10, 20, and 31 weeks
Fecal samples are taken and bacterial DNA is sequenced to determine bacterial composition
0, 10, 20, and 31 weeks
Change in dietary habits
Tidsramme: 0, 10, 20, and 31 weeks
85 item food frequency questionnaire
0, 10, 20, and 31 weeks
Change in concentration of inflammatory markers
Tidsramme: 0, 10, 20, and 31 weeks
0, 10, 20, and 31 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Anna Nordström, PhD, Umeå University

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.

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 (Faktiske)

9. februar 2018

Primær færdiggørelse (Forventet)

28. september 2018

Studieafslutning (Forventet)

28. september 2018

Datoer for studieregistrering

Først indsendt

16. februar 2018

Først indsendt, der opfyldte QC-kriterier

28. februar 2018

Først opslået (Faktiske)

1. marts 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • VCC-LIFE-4

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Visceral fedme

Kliniske forsøg med 10-week aerobic exercise program

Abonner