A Lifestyle Physical Activity Intervention for Older Sedentary Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Lifestyle Physical Activity Intervention for Older Sedentary Women

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Behavioral: Lifestyle Physical Activity Intervention
* Behavioral: Information / Attention Comparison


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Physical Activity Intervention<br>the women will be randomized to either the LPA Intervention or Information/Attention Comparison groups using a permuted block randomization scheme. Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer & LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months. | Behavioral: Lifestyle Physical Activity Intervention<br>* Physical Activity Information given plus Behavioral counseling using motivational interviewing & follow-up<br>|
| Active Comparator: Information/Attention Comparison<br>the women will be randomized to either the LPA Intervention or Information/Attention Comparison groups using a permuted block randomization scheme. Participants in both groups will be followed longitudinally with repeated assessments of LPA (accelerometer & LPA diary), stage of change, and self-efficacy at baseline and 3 and 6 months; and functional health and well-being (SF36) at baseline and 6 months. | Behavioral: Information / Attention Comparison<br>* Physical Activity information given & follow-up, no behavioral counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accelerometer Vector Magnitude Counts | motion data counts calculated from three axes | 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step of Counts (Per Day) | Number of steps that a person takes per day | 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, prevention, coronary heart disease, women