- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00183014
Caminemos! Trial to Increase Walking Among Sedentary Older Latinos
Trial to Increase Walking Among Sedentary Older Latinos
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Regular physical activity contributes to the health and quality of life of older adults, but unfortunately only 20% of men and 25% of women aged 65 years and greater meet the minimal national guidelines for physical activity. Older Latinos have higher rates of diseases that are most likely to benefit from physical activity, but have disproportionately high rates of sedentary lifestyle. To address this major public health problem, this study will implement and evaluate a multifaceted intervention to raise and sustain walking levels among older Latinos.
A total of 600 sedentary older Latinos will be recruited from community-based senior centers in the greater Los Angeles region. The specific aims of the study are to test the effect of the intervention on:
- the change in steps per week measured by digital pedometer from baseline to 1, 12, and 24-month follow-up;
- self-reported physical activity level and intervening constructs (including expectations regarding aging and self-efficacy expectations for physical activity);
- psychosocial health constructs, physical performance measures, and clinical health outcomes.
The core of the intervention consists of a series of 4 weekly 1-hour group discussion sessions that utilize attribution retraining techniques from the field of motivational psychology in combination with behavioral strategies based in social cognitive theory. Discussion sessions will be conducted at senior centers and led by a bilingual health educator; each session will be followed by a 1-hour exercise class aimed at increasing strength, flexibility and endurance. During the discussion sessions, the health educator will administer a structured culturally-tailored curriculum in which participants are taught to raise their expectations for physical activity with aging and not to attribute being sedentary to "old age." The 4 weekly sessions will be followed by monthly sessions for 11 months, and sessions every 2 months for the following 12 months (total intervention duration = 24 months). Participants will be randomized to 1 of 2 arms:
- intervention arm: receiving the discussion session and the exercise class;
- control arm: receiving just the exercise class with the same frequency and duration as the intervention group.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater, 90095
- UCLA Division of Geriatrics
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Aged 60 years or older
- Self-identifying as Latino/Hispanic
- Not currently participating in 20 minutes or more of physical activity 3 times a week
- Willingness to take brief physical activity screening test and if do not pass, provide the name of a physician who has seen the patient in the recent past
Exclusion Criteria:
- Plans to move from the area in the next 24 months
- Unable to participate in 1-hour group discussion
- Unable to walk
- Physician stating that patient is not medically able to participate
- Family member already participating
- Substantial cognitive impairment (determined by a screening test)
Studieplan
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: 1
discussion session and exercise class
|
A series of 4 weekly 1-hour group discussion sessions that utilize attribution retraining techniques from the field of motivational psychology in combination with behavioral strategies based in social cognitive theory; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
1-hour exercise class aimed at increasing strength, flexibility and endurance; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
|
|
Aktiv komparator: 2
exercise class only
|
1-hour exercise class aimed at increasing strength, flexibility and endurance; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of steps per week on digital pedometer
Tidsramme: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Self-reported physical activity level
Tidsramme: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
beliefs about aging
Tidsramme: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
self-efficacy
Tidsramme: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
health-related quality of life
Tidsramme: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
blood pressure
Tidsramme: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
body mass index (BMI)
Tidsramme: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
physical performance measures
Tidsramme: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
hospital days
Tidsramme: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
outpatient visits
Tidsramme: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
restricted activity days
Tidsramme: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
cognitive function
Tidsramme: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Catherine Sarkisian, MD, MSPH, UCLA Division of Geriatrics
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- AG0049
- 5R01AG024460-02 (U.S. NIH-bevilling/kontrakt)
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 .