Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study (IMPACT)

15 mars 2021 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

354

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Palo Alto, California, Förenta staterna, 94304
        • Stanford University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: Structured Group Exercise
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.
Experimentell: 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.
Beteende: Structured Group Exercise
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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Changes in Hemoglobin A1c Level Across Study Visits
Tidsram: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Maximal Oxygen Consumption Across Study Visits
Tidsram: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Self-Reported Physical Activity Level Across Study Visits
Tidsram: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

Sekundära resultatmått

Resultatmått
Tidsram
Changes in Body Weight Across Study Visits
Tidsram: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Body Mass Index Across Study Visits
Tidsram: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Waist Circumference Across Study Visits
Tidsram: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Blood Pressure Across Study Visits
Tidsram: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Heart Rate Across Study Visits
Tidsram: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Dietary Intake Across Study Visits
Tidsram: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Self-Reported Quality of Life Across Study Visits
Tidsram: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Exercise Perception Across Study Visits
Tidsram: Baseline, 6-, 30-month follow-up
Baseline, 6-, 30-month follow-up
Changes in Patient Satisfaction During Intervention Period
Tidsram: 3-, 6-month follow-up
3-, 6-month follow-up

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Stanford University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 oktober 2016

Primärt slutförande (Faktisk)

1 januari 2020

Avslutad studie (Faktisk)

1 januari 2020

Studieregistreringsdatum

Först inskickad

11 februari 2014

Först inskickad som uppfyllde QC-kriterierna

11 februari 2014

Första postat (Uppskatta)

13 februari 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 mars 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 mars 2021

Senast verifierad

1 mars 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 31635
  • U.S. NIH Grant 5R18DK096394 (Annat bidrag/finansieringsnummer: U.S. NIH Grant/Contract Award Number)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Diabetes mellitus

Kliniska prövningar på Structured Group Exercise

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Congo

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera