- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00183014
Caminemos! Trial to Increase Walking Among Sedentary Older Latinos
Trial to Increase Walking Among Sedentary Older Latinos
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
California
-
Los Angeles, California, Spojené státy, 90095
- UCLA Division of Geriatrics
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
|
|
Aktivní komparátor: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Number of steps per week on digital pedometer
Časové okno: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Self-reported physical activity level
Časové okno: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
beliefs about aging
Časové okno: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
self-efficacy
Časové okno: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
health-related quality of life
Časové okno: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
blood pressure
Časové okno: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
body mass index (BMI)
Časové okno: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
physical performance measures
Časové okno: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
hospital days
Časové okno: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
outpatient visits
Časové okno: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
restricted activity days
Časové okno: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
cognitive function
Časové okno: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Catherine Sarkisian, MD, MSPH, UCLA Division of Geriatrics
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- AG0049
- 5R01AG024460-02 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .