A Lifestyle Physical Activity Intervention for Older Sedentary Women
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Heart Disease |
Behavioral: Lifestyle Physical Activity Intervention Behavioral: Information / Attention Comparison |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | A Lifestyle Physical Activity Intervention for Older Sedentary Women |
- Accelerometer (energy expenditure) [ Time Frame: Baseline, 3 month, six month and completion ] [ Designated as safety issue: Yes ]This activity monitor uses a solid-state triaxial accelerometer to collect motion data on three axes for the highest level of analytic capabilities.
- Functional health [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]SF-36
- Self-Efficacy [ Time Frame: 3 and 6 month ] [ Designated as safety issue: Yes ]Self-Efficacy for Exercise Scale
- Stage of Change [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]Exercise Stage of Change
| Estimated Enrollment: | 145 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lifestyle Physical Activity Intervention
the women will be randomized to either the LPA Intervention (n=60) or Information/Attention Comparison (I/A, n=60) 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
Behavioral counseling
|
|
Active Comparator: Information/Attention Comparison
the women will be randomized to either the LPA Intervention (n=60) or Information/Attention Comparison (I/A, n=60) 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
Information and attention comparison
|
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 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 CHD 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| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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 unforseen pathology that precludes safe participation
Contacts and Locations| United States, Arkansas | |
| University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Leanne L Lefler, PhD, RN 501-296-1939 L.Lefler@uams.edu | |
| Principal Investigator: Leanne L Lefler, PhD, APN, RN | |
| Sub-Investigator: Jean C McSweeney, PhD, RN | |
| Sub-Investigator: Kimberly K Garner, MD, JD, MPH | |
| Principal Investigator: | Leanne L Lefler, PhD | University of Arkansas |
More Information
No publications provided
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT01707693 History of Changes |
| Other Study ID Numbers: | 135603 |
| Study First Received: | October 12, 2012 |
| Last Updated: | April 25, 2013 |
| Health Authority: | United States:University of Arkansas for Medical Sciences, Center for Clinical and Translational Research, Data Safety and Monitoring Board |
Keywords provided by University of Arkansas:
|
physical activity prevention coronary heart disease women |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013