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Completed

NCT Number: NCT01707693

A Lifestyle Physical Activity Intervention for Older Sedentary Women

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.

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Key information

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Physical Activity Intervention

Behavioral

Physical Activity Information given plus Behavioral counseling using motivational interviewing & follow-up

Information / Attention Comparison

Behavioral

Physical Activity information given & follow-up, no behavioral counseling

Primary outcomes

  1. Accelerometer Vector Magnitude Counts

    Time frame: 3 and 6 months

    motion data counts calculated from three axes

Secondary outcomes

  1. Step of Counts (Per Day)

    Time frame: 3 and 6 months

    Number of steps that a person takes per day

Other outcomes

  1. Self-Efficacy

    Time frame: Baseline, 3mths, 6mths

    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.

  2. Stage of Change (SOC)

    Time frame: Baseline, 3 and 6 months

    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

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Acronym: LPAW

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 16, 2012
Registry last updated
Oct 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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