Physical Activity Behavior Change for Older Adults After Dysvascular Amputation (PABC)
6. februar 2020 opdateret af: VA Office of Research and Development
Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation
This pilot study will use mobile-health technology to deliver an intervention designed for lasting physical activity behavior change.
The study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb amputation.
This intervention will be delivered using wrist-worn wearable activity sensors and a home-based tablet computer to allow real-time physical activity feedback and video interface between the participants and the therapist.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
This pilot study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with dysvascular lower limb amputation. In addition, preliminary efficacy of the PABC intervention will be assessed using a two-group randomized cross-over design. Testing will occur at baseline (pre-intervention), three months (end of intervention), and six months. The primary aim is to determine feasibility of using the PABC intervention with Veterans who have dysvascular amputation by measuring:
- participant retention
- dose goal attainment
- participant acceptability
- safety The secondary aim is to preliminary assess efficacy of the PABC intervention by measuring accelerometer-based physical activity and self-report disability effect sizes.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
31
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
-
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
50 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Lower limb amputation 1-5 years prior to enrollment
- Type 2 Diabetes Mellitus and/or
- Peripheral Artery Disease
- Ambulatory using a lower limb prosthesis
- English speaking
Exclusion Criteria:
- Traumatic or cancer-related etiology of the lower limb amputation
Unstable heart condition, including:
- unstable angina
- uncontrolled cardiac dysrhythmia
- acute myocarditis
- acute pericarditis
- Uncontrolled hypertension
- Acute systemic infection
- Prisoner
- Decisionally challenged volunteers
- Cancer
- Recent cerebral vascular accident (within two years)
- lower extremity wound or ulcer that limits ability to ambulate
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: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Early PABC Intervention
GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months.
GROUP 1 will then participate in a non-exercise control phase during the second 3 months.
|
Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity.
Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist.
Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity.
Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist.
Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning
|
|
Eksperimentel: Wait-List Control Intervention
GROUP 2 will participate in a non-exercise control phase during the first 3 months.
GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.
|
Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity.
Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist.
Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity.
Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist.
Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Retention Rate
Tidsramme: 3 months
|
Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
|
3 months
|
|
Dose Goal Attainment
Tidsramme: 3 months
|
Dose goal attainment will be measured as the percent of participants in the intervention phase of the study who meet the dose goal of an average 3% increase in daily steps.
|
3 months
|
|
Acceptability
Tidsramme: 3 months
|
Acceptability will be measured using the mean score of the Intrinsic Motivation Inventory - Interest / Enjoyment Subscale.
The scores range from 1 to 7, with higher numbers indicating higher acceptability, and a null value of 5.0.
|
3 months
|
|
Study-Related Adverse Events
Tidsramme: 3 months
|
Safety will be assessed as differences in rates of study-related adverse events between GROUP 1 and GROUP 2 during the first three months, when GROUP 1 is in the intervention phase and GROUP 2 is in the non-intervention control phase.
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Accelerometer-Based Physical Activity
Tidsramme: 3 months
|
Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph).
The outcome will be average daily physical activity counts.
|
3 months
|
|
Late Life Function and Disability Scale, Frequency
Tidsramme: 3 months
|
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point.
Scores range from 0 to 100, with higher scores indicating higher disability.
|
3 months
|
|
Accelerometer-Based Physical Activity
Tidsramme: 6 months
|
Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph).
The outcome will be average daily physical activity counts.
|
6 months
|
|
Late Life Function and Disability Scale, Frequency
Tidsramme: 6 months
|
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point.
Scores range from 0 to 100, with higher scores indicating higher disability.
|
6 months
|
|
Late Life Function and Disability Scale, Limitation
Tidsramme: 3 months
|
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point.
Scores range from 0 to 100, with higher scores indicating higher disability.
|
3 months
|
|
Late Life Function and Disability Scale, Limitation
Tidsramme: 6 months
|
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point.
Scores range from 0 to 100, with higher scores indicating higher disability.
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. juli 2016
Primær færdiggørelse (Faktiske)
22. februar 2019
Studieafslutning (Faktiske)
22. februar 2019
Datoer for studieregistrering
Først indsendt
16. marts 2016
Først indsendt, der opfyldte QC-kriterier
8. april 2016
Først opslået (Skøn)
14. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. februar 2020
Sidst verificeret
1. februar 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- F2054-P
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