A Lifestyle Physical Activity Intervention for Older Sedentary Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01707693
First received: October 12, 2012
Last updated: May 19, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Functional health [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]
    SF-36


Other Outcome Measures:
  • 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 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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707693

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    LLefler@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         
Sponsors and Collaborators
University of Arkansas
Investigators
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: May 19, 2014
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 July 28, 2014