Physical Activity and Participation
8. september 2022 opdateret af: VA Office of Research and Development
Veterans With Diabetes Mellitus: Improving Physical Activity and Participation
The purpose of the study is to investigate if the investigators can improve physical activity and social participation level among Veterans with diabetes.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Physical activity is the cornerstone of good diabetes management, and yet effective physical activity intervention is not available.
The investigators developed a lifestyle intervention based on individual's home activity patterns.
The goal of the study is to test the efficacy of this intervention among Veterans with diabetes in a randomized-controlled trial.
In addition to physical activity, the investigators will also assess if the intervention will improve social participation among Veterans.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
104
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
-
-
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
56 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Veterans
- Aged 60 years or older
- Has Type 2 diabetes mellitus
- Able to operate accelerometer
- Competent to consent to the study
- No dementia diagnosis
- Ambulatory with or without assistive device
- English-speaking
- Community living (i.e., not a nursing home resident)
- Not physically active on a regular basis (less than 150 minutes of moderate or vigorous physical activity per week)
Exclusion Criteria:
- Medically unstable
- Hospitalized within the last 6 months
- 2 or more days of complete bed rest in the last month
- hemiplegia or limb amputation
- Self-reported illness or conditions that would impair the cooperation with the study team or the ability to complete the study
- work involved in shift schedule
- current enrollment of a physical activity program
- replacement of hip or knee within the last 6 months.
- Parkinson's disease
- frequent falls
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention
OT-ledet rådgivning baseret på hjemmeaktivitetsmønster
|
OT ledet rådgivning
|
|
Placebo komparator: Wait-listed
Usual activity during the study.
At the end of the study, will receive OT-led counseling
|
At the end of the study, will receive OT-led counseling
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical Activity
Tidsramme: 6 months
|
Home physical activity changes from baseline to 6-months.Physical activity was measured using a validated survey called CHAMPS, asking the participants to report activities that they participated in a typical week, such as walking, doing house work, dancing, etc.
|
6 months
|
|
Social Participation
Tidsramme: 6 months
|
Survey questionnaires of participation change from baseline to 6-months follow up, specifically, satisfaction with participation in social roles, satisfaction with participation in discretionary social activities, and ability to participate in social roles and activities.
Each survey has been validated and scored on the T-score metrics.
A T-score is a standardized score, and has a "middle" score; it is 50 for T-scores.
This middle score is the mean of a large sample that is representative of the US general population.
The survey results are T-score metrics in which 50 is the mean score of the general population and 10 is the standard deviation (SD) of that population.
The study outcomes are changes in T-scores of each survey from baseline to 6-months follow-up, where positive score means improved outcome, and negative score means worse outcome at 6-months.
|
6 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical Function
Tidsramme: 6 months
|
Six month changes in timed up and go test, where the participant get up from sitting in a chair, walk meters, turn around, and walk back to sit down.
Positive changes means worse outcome for timed up and go (seconds).
|
6 months
|
|
Physical Function
Tidsramme: 6 months
|
Six month changes in gait speed, which is the comfortable gait peed in 10 meter walking.
Positive changes means better outcomes for gait speed (meters per second).
|
6 months
|
|
Physical Function
Tidsramme: 6 months
|
Six month changes in six-minute walk test, which measures the distance a participant walked at usual pace for six minutes.
Positive changes means better outcomes for six-minute walk (meters).
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Pearl G. Lee, MD, VA Ann Arbor Healthcare System, Ann Arbor, MI
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)
1. juni 2015
Primær færdiggørelse (Faktiske)
31. december 2019
Studieafslutning (Faktiske)
31. december 2019
Datoer for studieregistrering
Først indsendt
15. oktober 2014
Først indsendt, der opfyldte QC-kriterier
15. oktober 2014
Først opslået (Skøn)
20. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. september 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. september 2022
Sidst verificeret
1. september 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- O1190-W
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .