- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04696614
Testing the Effect of Exercise Intervention Using a SMART Design.
6. april 2022 opdateret af: Yu-Hsuan Chang, National Taiwan University
Developing and Testing the Effect of Exercise Intervention Using a SMART Design on Reducing Visceral Adipose Tissue in Community Residents: A Mixed-Method, Longitudinal Study.
Exercise is the most effective way on reducing visceral adipose tissue (VAT), which is strongly linked with obesity to hypertension, cardiovascular disease, and insulin resistance.
However, the current exercise dosage for reducing VAT cannot be accurately quantified.
The aims of this study are to develop and test the optimal exercise dosage and sequence for reducing VAT in overweight and obese community residents.
Purposive sampling will be used to enroll at least 206 participants aged 40-65 years and body fat more than 30% without diet control from 2 community centers in southern Taiwan.
The project will use the sequential multiple assignment randomized trial (SMART) design to conduct a 16-week 2-stage (each for 8-weeks) adaptive exercise intervention for community residents.
In the first stage, participants will be randomized into groups performing 8 weeks either moderate intensity of aerobic exercise or interval training 3 times per week.
Participants whose VAT does not decrease by over 3%, measured using a body composition analyzer, compared with the baseline will be 1:1 rerandomized into groups with aerobic exercise combined with resistance exercise or received the exchange of first stage treatment (interval training or aerobic exercise) in the second stage.
Those with substantial response to the first-stage intervention (VAT reduction of more than 3%) will continue to receive the same exercise treatment until 16 weeks.
Linear mixed model, weighted and replicated regression will be used to identify the optimal sequence of exercises for the greatest reduction in VAT.
The findings can assist clinical health workers to develop exercise prescriptions for effectively reducing VAT, and help community residents reduce VAT through exercise to achieve the health promotion.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
116
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Tainan, Taiwan
- Community center
-
-
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
40 år til 64 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Community residents (a) who are 40-65 years old without diet control, (b) body fat ≧ 30% measured by body composition analyzer, and (c) can communicate in Mandarin or Taiwanese will be included.
Exclusion Criteria:
- This study will exclude residents with (a) recent unstable condition involving stroke or those with heart disease, handicap, pregnancy, mental disorders, systolic BP > 200 mmHg, or diastolic BP >110 mmHg; and (b) those with contraindications in body composition analyzer measurement including people with pacemakers, artificial metal joints, amputated hands or feet, and those who cannot be cooperated with standing during testing.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: aerobic exercise to aerobic exercise
first 8-week: aerobic exercise second 8-week: aerobic exercise
|
intervention groups provided different sequential modality of exercise
|
|
Eksperimentel: aerobic exercise to interval training
first 8-week: aerobic exercise second 8-week: interval training
|
intervention groups provided different sequential modality of exercise
|
|
Eksperimentel: aerobic exercise to aerobic exercise +resistance exercise
first 8-week: aerobic exercise second 8-week: aerobic exercise +resistance exercise
|
intervention groups provided different sequential modality of exercise
|
|
Eksperimentel: interval training to interval training
first 8-week: interval training second 8-week: interval training
|
intervention groups provided different sequential modality of exercise
|
|
Eksperimentel: interval training to aerobic exercise
first 8-week: interval training second 8-week: aerobic exercise
|
intervention groups provided different sequential modality of exercise
|
|
Eksperimentel: interval training to aerobic exercise+resistance exercise
first 8-week: interval training second 8-week: aerobic exercise +resistance exercise
|
intervention groups provided different sequential modality of exercise
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
visceral adipose tissue
Tidsramme: three times (baseline, change visceral adipose tissue from Baseline to 8 week, change visceral adipose tissue from Baseline to 16 week)
|
measured using body composition analyzer
|
three times (baseline, change visceral adipose tissue from Baseline to 8 week, change visceral adipose tissue from Baseline to 16 week)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
10. november 2020
Primær færdiggørelse (Faktiske)
4. januar 2021
Studieafslutning (Faktiske)
31. juli 2021
Datoer for studieregistrering
Først indsendt
4. januar 2021
Først indsendt, der opfyldte QC-kriterier
5. januar 2021
Først opslået (Faktiske)
6. januar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 108466
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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