- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00183014
Caminemos! Trial to Increase Walking Among Sedentary Older Latinos
Trial to Increase Walking Among Sedentary Older Latinos
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
California
-
Los Angeles, California, Stati Uniti, 90095
- UCLA Division of Geriatrics
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Comparatore attivo: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Number of steps per week on digital pedometer
Lasso di tempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Self-reported physical activity level
Lasso di tempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
beliefs about aging
Lasso di tempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
self-efficacy
Lasso di tempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
health-related quality of life
Lasso di tempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
blood pressure
Lasso di tempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
body mass index (BMI)
Lasso di tempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
physical performance measures
Lasso di tempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
hospital days
Lasso di tempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
outpatient visits
Lasso di tempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
restricted activity days
Lasso di tempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
|
cognitive function
Lasso di tempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Catherine Sarkisian, MD, MSPH, UCLA Division of Geriatrics
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- AG0049
- 5R01AG024460-02 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .