Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study (IMPACT)
15. mars 2021 oppdatert av: Latha Palaniappan, MD, MS, Stanford University
The Initiate and Maintain Physical Activity in Clinics (IMPACT) study will determine the optimal and feasible level of frequency of structured contact needed in a clinical setting for adult patients with Type 2 Diabetes Mellitus to initiate and maintain physical activity recommendations long-term.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The IMPACT Study will compare the health outcomes and lifestyle habits amongst the three groups of study participants.
Study participants will be randomized into three exercise group.
Group 1 will participate in instructor-led exercise training sessions 1 time per week, for 24 weeks (approximately 6 months).
Group 2 will participate in instructor-led exercise training sessions 3 times per week, for 24 weeks (approximately 6 months).
Group 3 will not attend any instructor-led exercise training sessions.
All groups will be encouraged to see their usual providers for routine healthcare, and continue their usual medication regimen.
Studietype
Intervensjonell
Registrering (Faktiske)
354
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
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Palo Alto, California, Forente stater, 94304
- Stanford University
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Recent hemoglobin A1c result between 6.5 and 13.0%
- Diagnosed with Type 2 Diabetes Mellitus
- Able and willing to enroll and meet the requirements of the study
Exclusion Criteria:
- Inability to speak, read or understand English
- Long-term current use or dependency on insulin
- Systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg
- Resting heart rate > 120 bpm
- History of or present heart or cardiovascular conditions
- History of or present respiratory disease
- History of or present spinal cord injury
- History of stroke or Transient Ischemic Attack (TIA)
- History of cancer diagnosis in the past 5 years or present cancer diagnosis
- Medical, psychiatric, behavioral limitations that may interfere with study participation
- Participating in other clinical trials that may interfere with study procedures and outcomes
- Currently pregnant or plans to become pregnant within three years
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Once-Weekly Structured Contact
Participants in the Once Weekly Structured Contact group will take part in an 6-month exercise intervention and attend one structured group exercise session per week.
They will engage in aerobic and resistance training for approximately 80 minutes per exercise session.
Additionally, they will attend three exercise evaluations and six study visits.
|
The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting.
Group sessions include Aerobic Training and Combined Training.
Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week.
Participants in both groups will attend three exercise evaluations during the intervention period.
Participants will also use provided logs to track their daily exercise activities outside of group sessions.
Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.
|
|
Eksperimentell: Thrice-Weekly Structured Contact
Participants in the Thrice-Weekly Structured Contact group will take part in an 6-month exercise intervention and attend three structured group exercise sessions per week.
In total, they will engage in aerobic and resistance training sessions for approximately 200 minutes per week.
Additionally, they will attend three exercise evaluations and six study visits.
|
The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting.
Group sessions include Aerobic Training and Combined Training.
Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week.
Participants in both groups will attend three exercise evaluations during the intervention period.
Participants will also use provided logs to track their daily exercise activities outside of group sessions.
Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.
|
|
Ingen inngripen: Usual Care
Participants in the Usual Care group will not take part in an 6-month exercise intervention.
They will continue to seek regular care from their primary care providers and attend six study visits.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Changes in Hemoglobin A1c Level Across Study Visits
Tidsramme: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
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Changes in Maximal Oxygen Consumption Across Study Visits
Tidsramme: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
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Changes in Self-Reported Physical Activity Level Across Study Visits
Tidsramme: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Changes in Body Weight Across Study Visits
Tidsramme: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
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Changes in Body Mass Index Across Study Visits
Tidsramme: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
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Changes in Waist Circumference Across Study Visits
Tidsramme: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
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Changes in Blood Pressure Across Study Visits
Tidsramme: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
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Changes in Heart Rate Across Study Visits
Tidsramme: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
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Changes in Dietary Intake Across Study Visits
Tidsramme: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
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Changes in Self-Reported Quality of Life Across Study Visits
Tidsramme: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
|
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
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Changes in Exercise Perception Across Study Visits
Tidsramme: Baseline, 6-, 30-month follow-up
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Baseline, 6-, 30-month follow-up
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Changes in Patient Satisfaction During Intervention Period
Tidsramme: 3-, 6-month follow-up
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3-, 6-month follow-up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2016
Primær fullføring (Faktiske)
1. januar 2020
Studiet fullført (Faktiske)
1. januar 2020
Datoer for studieregistrering
Først innsendt
11. februar 2014
Først innsendt som oppfylte QC-kriteriene
11. februar 2014
Først lagt ut (Anslag)
13. februar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. mars 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. mars 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 31635
- U.S. NIH Grant 5R18DK096394 (Annet stipend/finansieringsnummer: U.S. NIH Grant/Contract Award Number)
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