Clinical trial NCT01707693: A Lifestyle Physical Activity Intervention for Older Sedentary Women
Official title: A Lifestyle Physical Activity Intervention for Older Sedentary Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: physical activity
prevention
coronary heart disease
women
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 121
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Making physical activity an integral part of daily life is imperative to the health and well-being of our nation's older adults. However, no intervention strategy to encourage daily physical activity for older adults, especially older women, has been effective. This feasibility study will test a multi-tailored motivational intervention to increase usual lifestyle physical activity of older sedentary women to reduce their coronary heart disease risks.

Detailed description: Over 98% of older women do not meet national guidelines for physical activity (PA). There is clear evidence that a physically active lifestyle reduces the human and economic cost of heart disease in a dose-response relationship; but current efforts to increase long-term PA in older women are inadequate. The aims of this proposed research are to: 1) determine the feasibility of using an individually tailored motivational counseling intervention method to promote lifestyle physical activity (LPA) in older sedentary women; 2) examine intervention effects by comparing baseline to outcome measures at 3 and 6 months in treatment and information/attention comparison groups; and 3) explore stage of behavior change and self-efficacy and their relationship to LPA, along with functional health.

This will be a single blinded randomized controlled study of sedentary women aged 60 years and older. We will replace "structured aerobic exercise" with lifestyle physical activity (LPA), i.e., self-selected activities performed daily in a purposeful manner to meet the national PA guidelines. A total of 120 older women who are ambulatory and cognitively intact will be recruited from a senior health clinic and randomized to receive either the motivational LPA intervention or information/attention. Women will be assessed at baseline, 3 and 6 months. The theoretically based behavioral intervention is derived from the Transtheoretical Model and other evidence-based physical activity research. We will use a Motivational Interviewing counseling technique delivered by a social worker to individually tailor the LPA intervention to participant preferences, taking into consideration their functional ability and need for information, readiness to change, and self-efficacy. Outcomes of the LPA intervention sessions will include tailored goals and an LPA plan. Intervention participants will also receive the newly developed NIA "Exercise \& You" LPA informational booklet with companion digital video disc (DVD) as well as motivational coaching via telephone calls, tapering in frequency for 6 months. The control group will receive the NIA LPA booklet with DVD and attention telephone calls. We will assess changes from baseline in LPA (primary outcome), readiness to change, self-efficacy and function (secondary outcomes) and examine the associations between primary and secondary outcomes in both groups. The allied disciplines of Nursing, Gerontology, Social Work, and Medicine will collaborate to promote PA and cardiovascular health of older women. Undergraduate and graduate student research assistants will contribute to this project. This research has the potential to increase PA of sedentary older women and reduce coronary heart disease risks. If we could increase physical activity in our rapidly growing older population -even modestly, we could make a significant impact to the health of our nation.

Eligibility criteria: Inclusion Criteria:

* women \> 60 years of age who are Senior Health clinic patients
* health care provider's approval to participate
* ability to speak/read English
* access to a telephone

Exclusion Criteria:

* report participation in a regular physical activity program
* report an unresolved acute illness, such as pneumonia or flu
* fail screening for capacity to provide informed consent
* fail a simple functional screen or are currently nonambulatory
* are unable to complete activities of daily living
* have uncorrectable severe hearing or vision deficits
* have a history of falls in the past 3 months
* have other unforeseen pathology that precludes safe participation

Primary outcomes:
measure: Accelerometer Vector Magnitude Counts
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Step of Counts (Per Day)
timeFrame: 3 and 6 months
Other outcomes:
measure: Self-Efficacy
timeFrame: Baseline, 3mths, 6mths
measure: Stage of Change (SOC)
timeFrame: Baseline, 3 and 6 months
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Leanne L Lefler, PhD
role: PRINCIPAL_INVESTIGATOR
References: