- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03450655
Cardio Training of Older Adults With Central Obesity
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Västerbotten
-
Umeå, Västerbotten, Schweden, 907 36
- Livsmedicin (LIFE)
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in visceral adipose tissue mass
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in body composition
Zeitfenster: 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)
Zeitfenster: 0, 10, 20, and 31 weeks
|
0, 10, 20, and 31 weeks
|
|
Change in blood pressure (mmHg)
Zeitfenster: 0, 10, 20, and 31 weeks
|
Taken after 15 min of rest
|
0, 10, 20, and 31 weeks
|
Change in blood-lipid profile
Zeitfenster: 0, 10, 20, and 31 weeks
|
0, 10, 20, and 31 weeks
|
|
Change in fasting blood glucose
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 0, 10, 20, and 31 weeks
|
As measured by indirect calorimetry
|
0, 10, 20, and 31 weeks
|
Change in health-related quality of life
Zeitfenster: 0, 10, 20, and 31 weeks
|
As measured by RAND-36
|
0, 10, 20, and 31 weeks
|
Change in self-reported physical activity
Zeitfenster: 0, 10, 20, and 31 weeks
|
Assessed using IPAQ-SF
|
0, 10, 20, and 31 weeks
|
Change in Microbiota composition
Zeitfenster: 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
Zeitfenster: 0, 10, 20, and 31 weeks
|
85 item food frequency questionnaire
|
0, 10, 20, and 31 weeks
|
Change in concentration of inflammatory markers
Zeitfenster: 0, 10, 20, and 31 weeks
|
0, 10, 20, and 31 weeks
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Anna Nordström, PhD, Umea University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- VCC-LIFE-4
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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