- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04974476
Onsite vs. Virtual Group Fitness in Overweight/Obese Women
9. november 2021 opdateret af: Arlette Perry, University of Miami
A Comparison of Onsite vs. Virtual Fitness Program on Anthropometric Measures, Aerobic Fitness, and Vascular Markers of Cardiac Risk Markers in Overweight/Obese Premenopausal Women
The purpose of this study is to compare an onsite to virtual whole-body high intensity interval training (HIIT) program on anthropometric variables, aerobic fitness measures, and vascular markers of cardiac risk in a single study of overweight and obese women.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
35
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Florida
-
Coral Gables, Florida, Forenede Stater, 33134
- University of Miami
-
-
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
18 år til 44 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Premenopausal adult females over the age of 18 and under the age of 45 with a BMI greater than or equal to 25 and a waist circumference greater than or equal to 35 inches.
- No medical contraindications to participation in an exercise program including major medical illnesses (i.e. cardiovascular disease, stroke, cancer, etc.)
- Ability to provide informed consent
- Willingness and ability to participate in an interval training in-person group fitness exercise program 3x/week for 12 weeks
Exclusion Criteria:
- Adults unable to consent or mini-mental score less than 18.
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Post-menopausal women
- Do not speak English
- Prisoners
- Subjects on medicines (serum glucose, insulin, weight loss medicines, beta-blockers) and having any medical pre-conditions that would interfere with one's capacity to exercise.
- Answer "Yes" to any of the questions on the Pre-Activity Screening Questionnaire (PASQ)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: In-person exercise training group
participants in this group will receive in person exercise HIIT training 3 days a week for 12 weeks
|
The HIIT total session duration will be approximately 30 minutes and will be composed of 10 sets of 60 seconds of high-intensity exercises, >80% of maximum heart rate (MHR), interspersed with a recovery period of 60 seconds of low-intensity exercise at 60% of MHR.
|
Eksperimentel: Virtual exercise training group
participants in this group will receive virtual exercise HIIT training 3 days a week for 12 weeks
|
The HIIT total session duration will be approximately 30 minutes and will be composed of 10 sets of 60 seconds of high-intensity exercises, >80% of maximum heart rate (MHR), interspersed with a recovery period of 60 seconds of low-intensity exercise at 60% of MHR.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pulse Wave Velocity (PWV)
Tidsramme: Up to 12 weeks
|
vascular marker of cardiac risk will be reported as PWV (m/s) as measured using SphygmoCor
|
Up to 12 weeks
|
Pulse Wave Analysis Augmentation Index (AIx)
Tidsramme: Up to 12 weeks
|
vascular marker of cardiac risk will be reported as AIx (%) as measured using SphygmoCor
|
Up to 12 weeks
|
Pulse Wave Analysis Mean Arterial Pressure (MAP)
Tidsramme: Up to 12 weeks
|
vascular marker of cardiac risk will be reported as MAP (mmHg) as measured using SphygmoCor
|
Up to 12 weeks
|
Visceral Adipose Tissue (VAT) content
Tidsramme: Up to 12 weeks
|
Anthropometric measure will be reported as VAT content as measured by noninvasive direct segmental multi-frequency bioelectrical impedance body composition analyzer
|
Up to 12 weeks
|
Total Adiposity
Tidsramme: Up to 12 weeks
|
Anthropometric measure will be reported as Total Adiposity as measured by noninvasive direct segmental multi-frequency bioelectrical impedance body composition analyzer
|
Up to 12 weeks
|
Aerobic Fitness
Tidsramme: Up to 12 weeks
|
Aerobic Fitness level as measured by the 20 meter shuttle run
|
Up to 12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Arlette C Perry, University of Miami
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)
24. juli 2021
Primær færdiggørelse (Faktiske)
8. november 2021
Studieafslutning (Faktiske)
8. november 2021
Datoer for studieregistrering
Først indsendt
14. juli 2021
Først indsendt, der opfyldte QC-kriterier
14. juli 2021
Først opslået (Faktiske)
23. juli 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. november 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20210038
Plan for individuelle deltagerdata (IPD)
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