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- Klinische proef NCT03450655
Cardio Training of Older Adults With Central Obesity
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Västerbotten
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Umeå, Västerbotten, Zweden, 907 36
- Livsmedicin (LIFE)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Intervention Group
Weeks 1-10: exercise program in group.
Weeks 11-20: no intervention.
Weeks 21-31: no intervention.
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An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.
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Experimenteel: Control group
Weeks 1-10: no intervention.
Weeks 11-20: no intervention.
Weeks 21-31: exercise program at home.
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An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in visceral adipose tissue mass
Tijdsspanne: 0, 10, 20, and 31 weeks
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Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA).
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0, 10, 20, and 31 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in body composition
Tijdsspanne: 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)
Tijdsspanne: 0, 10, 20, and 31 weeks
|
0, 10, 20, and 31 weeks
|
|
Change in blood pressure (mmHg)
Tijdsspanne: 0, 10, 20, and 31 weeks
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Taken after 15 min of rest
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0, 10, 20, and 31 weeks
|
Change in blood-lipid profile
Tijdsspanne: 0, 10, 20, and 31 weeks
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0, 10, 20, and 31 weeks
|
|
Change in fasting blood glucose
Tijdsspanne: 0, 10, 20, and 31 weeks
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Veinous blood samples taken after > 4 h of fasting
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0, 10, 20, and 31 weeks
|
Change in isometric muscle strength
Tijdsspanne: 0, 10, 20, and 31 weeks
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Measured in non-dominant hand with dynamometer (Jamar, Lafayette Instrument, USA).
The better of two successive trials will be recorded.
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0, 10, 20, and 31 weeks
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Change in physical capacity
Tijdsspanne: 0, 10, 20, and 31 weeks
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Measured using Åstrands Submaximal Test, performed on an electrically braked ergometer bicycle
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0, 10, 20, and 31 weeks
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Change in resting metabolic rate
Tijdsspanne: 0, 10, 20, and 31 weeks
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As measured by indirect calorimetry
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0, 10, 20, and 31 weeks
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Change in health-related quality of life
Tijdsspanne: 0, 10, 20, and 31 weeks
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As measured by RAND-36
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0, 10, 20, and 31 weeks
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Change in self-reported physical activity
Tijdsspanne: 0, 10, 20, and 31 weeks
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Assessed using IPAQ-SF
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0, 10, 20, and 31 weeks
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Change in Microbiota composition
Tijdsspanne: 0, 10, 20, and 31 weeks
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Fecal samples are taken and bacterial DNA is sequenced to determine bacterial composition
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0, 10, 20, and 31 weeks
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Change in dietary habits
Tijdsspanne: 0, 10, 20, and 31 weeks
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85 item food frequency questionnaire
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0, 10, 20, and 31 weeks
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Change in concentration of inflammatory markers
Tijdsspanne: 0, 10, 20, and 31 weeks
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0, 10, 20, and 31 weeks
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Anna Nordström, PhD, Umea University
Publicaties en nuttige links
Algemene publicaties
- Ballin M, Hult A, Bjork S, Lundberg E, Nordstrom P, Nordstrom A. Web-based exercise versus supervised exercise for decreasing visceral adipose tissue in older adults with central obesity: a randomized controlled trial. BMC Geriatr. 2020 May 12;20(1):173. doi: 10.1186/s12877-020-01577-w.
- Ballin M, Lundberg E, Sorlen N, Nordstrom P, Hult A, Nordstrom A. Effects of interval training on quality of life and cardiometabolic risk markers in older adults: a randomized controlled trial. Clin Interv Aging. 2019 Sep 4;14:1589-1599. doi: 10.2147/CIA.S213133. eCollection 2019.
- Ballin M, Lundberg E, Sorlen N, Nordstrom P, Hult A, Nordstrom A. Effects of Interval Training on Visceral Adipose Tissue in Centrally Obese 70-Year-Old Individuals: A Randomized Controlled Trial. J Am Geriatr Soc. 2019 Aug;67(8):1625-1631. doi: 10.1111/jgs.15919. Epub 2019 Apr 23.
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- VCC-LIFE-4
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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