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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00183014
Other study ID # AG0049
Secondary ID 5R01AG024460-02
Status Completed
Phase N/A
First received September 13, 2005
Last updated May 16, 2012
Start date September 2005
Est. completion date August 2009

Study information

Verified date May 2012
Source National Institute on Aging (NIA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the efficacy of a multifaceted behavioral intervention aimed at raising walking levels among sedentary older Latinos.


Description:

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:

1. the change in steps per week measured by digital pedometer from baseline to 1, 12, and 24-month follow-up;

2. self-reported physical activity level and intervening constructs (including expectations regarding aging and self-efficacy expectations for physical activity);

3. 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:

1. intervention arm: receiving the discussion session and the exercise class;

2. control arm: receiving just the exercise class with the same frequency and duration as the intervention group.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
The Lifetime Fitness Program
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
Exercise class
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

Locations

Country Name City State
United States UCLA Division of Geriatrics Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of steps per week on digital pedometer baseline and 1, 12, and 24-months No
Secondary Self-reported physical activity level baseline and 1, 12, and 24-months No
Secondary beliefs about aging baseline and 1, 12, and 24-months No
Secondary self-efficacy baseline and 1, 12, and 24-months No
Secondary health-related quality of life baseline and 1, 12, and 24-months No
Secondary blood pressure baseline and 1, 12, and 24-months No
Secondary body mass index (BMI) baseline and 1, 12, and 24-months No
Secondary physical performance measures baseline and 1, 12, and 24-months No
Secondary hospital days baseline and 1, 12, and 24-months No
Secondary outpatient visits baseline and 1, 12, and 24-months No
Secondary restricted activity days baseline and 1, 12, and 24-months No
Secondary cognitive function baseline and 1, 12, and 24-months No
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