Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.
30. november 2015 opdateret af: Carlos H Timaran, University of Texas Southwestern Medical Center
Peripheral Arterial Disease (PAD) is a highly prevalent public health problem that results from progressive atherosclerosis of arteries in the lower extremities.
PAD is also associated with major detrimental effects on quality of life and functional status, and is the most important cause of limb amputation.
More importantly, PAD is a major manifestation of cardiovascular disease and a potent predictor of myocardial infarction, stroke and death.
Despite its frequent occurrence, little is known about the natural history of PAD in Hispanics who represent 12.5% of the United States.
Because access to health care is limited among Hispanics, CBPR is the ideal process to reach this target population.
The goal of the proposed study is to evaluate community-based strategies of detection and treatment of peripheral arterial disease (PAD) in Hispanics.
The proposed project consists of two phases: a cross-sectional phase (PAD detection), followed by a randomization phase.During the PAD detection study , the prevalence and severity of PAD in this population will be determined.
Specific risk factors associated with PAD among the Hispanic participants will be identified.
During the second phase patients will be enrolled in a randomized, non-blinded trial comparing a community-based risk factor modification and supervised exercise program versus usual care for PAD.
These individuals will undergo a baseline evaluation similar to the one obtained during the first phase of the study, but will also include functional testing of the lower extremities.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
347
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Texas
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Dallas, Texas, Forenede Stater, 75390
- UT Southwestern Medical Center
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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
70 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Cross-Sectional phase:
- Hispanic men and women aged 70 years or older.
- Hispanic participants with diabetes mellitus or smokers aged 50 through 69 years.
- Individual has been informed of the nature, procedures and risks of the study, and has signed a consent form approved by UT Southwestern Institutional Review Board.
Randomization phase:
- Hispanic men and women aged 70 years or older
- English or Spanish speaking
- Hispanic participants with diabetes mellitus or smokers aged 50 through 69 years.
- Documented peripheral arterial disease with an Ankle-brachial index (ABI) < 0.9 or Toe-brachial index (TBI) <0.7, and abnormal Pulse Volume Recordings (PVR).
- Ability to ambulate independently.
- No prior amputations other than toe or partial foot amputations that do not impede walking.
- Patient has been informed of the nature, procedures and risks of the study, and has signed a consent form approved by the UT Southwestern Institutional Review Board.
Exclusion Criteria:
Cross-Sectional Phase
- Individuals with severe dementia.
- Individuals with inability to provide informed consent.
- Bilateral lower or upper extremities amputations.
- Pregnancy or lactation. Randomization Phase
- Non-ambulatory
- Individuals with prior below- or above-knee amputations
- Individuals unable to give informed consent
- Individuals unwilling to perform the functional tests or quality of life assessments
- Individuals unable to perform exercise therapy, functional tests or quality of life assessments due to severe comorbidities
- Presence of concurrent illness with an anticipated life expectancy less than six months
- Individuals with planned operative interventions
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: supervised exercise
It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week.
Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
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Supervised exercise Program consist of six months of supervised, intermittent track walking.
Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
During each exercise session, individuals will be encouraged to walk at a speed of approximately 2 mph until they achieve leg pain or discomfort on walking of moderate severity.Individuals are then allowed to have a brief period of standing or sitting rest to permit symptoms to resolve before they resume exercise.
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Ingen indgriben: Standard of Care
Patients will be observed during the time of the study, no intervention will be applied.
Patients are allowed to do their regular activity at home.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Effect of an Exercise Intervention on Walking Ability (Functional Outcome)
Tidsramme: 6 months
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Walking distance (Six-Minute Walk test).
Following a standardized protocol, individuals are instructed to walk back and forth a 100-ft hallway as far as they can in six minutes after instructions to cover as much distance as possible.
A research assistant walks slightly behind each participant so as not to pace the individual.
The research assistant records whether or not each person stops during the 6-minute walk.
During the proposed study, members of the research team and trained lay health promoters (LHPs) will walk directly behind the individuals and give standardized instructions of encouragement at set intervals.
Data will be reported on meters walked.
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Carlos H Timaran, MD, UT Southwestern Medical Center
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
1. februar 2008
Primær færdiggørelse (Faktiske)
1. februar 2013
Studieafslutning (Faktiske)
1. februar 2013
Datoer for studieregistrering
Først indsendt
22. september 2011
Først indsendt, der opfyldte QC-kriterier
23. september 2011
Først opslået (Skøn)
26. september 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. november 2015
Sidst verificeret
1. november 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0830128N
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 .