A Lifestyle Physical Activity Intervention for Older Sedentary Women (LPAW)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Behavioral: Lifestyle Physical Activity Intervention; Behavioral: Information / 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 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.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle Physical Activity Intervention; 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; Physical Activity Information given plus Behavioral counseling using motivational interviewing & follow-up
Active Comparator: Information/Attention Comparison; 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; Physical Activity information given & follow-up, no behavioral counseling

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy	Self-Efficacy for Exercise Scale used to estimate the strength of self-efficacy beliefs; The tool contains 9 items with an 0-10 answer format from "Not Confident to Very Confident" and summed numerical ratings; higher scores indicate greater self-efficacy.	Baseline, 3mths, 6mths
Stage of Change (SOC)	Exercise Stage of Change information on how ready an individual is to make a change related to participating in physical activity. It consists of four questions (Yes or No response format) in which the individual is rated on current stage of change	Baseline, 3 and 6 months

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Leanne L Lefler, PhD, University of Arkansas

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; prevention; women; coronary heart disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 135603