Coronary Heart Disease
Conditions
Keywords
physical activity, prevention, coronary heart disease, women
Brief summary
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
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.
Interventions
BEHAVIORALLifestyle Physical Activity Intervention
Physical Activity Information given plus Behavioral counseling using motivational interviewing & follow-up
BEHAVIORALInformation / Attention Comparison
Physical Activity information given & follow-up, no behavioral counseling
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
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 unforeseen pathology that precludes safe participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accelerometer Vector Magnitude Counts | 3 and 6 months | motion data counts calculated from three axes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Step of Counts (Per Day) | 3 and 6 months | Number of steps that a person takes per day |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-Efficacy | 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. |
| Stage of Change (SOC) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Lifestyle Physical Activity Intervention: Behavioral counseling | 59 |
| 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.
Information / Attention Comparison: Information and attention comparison | 62 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study Allocation | Protocol Violation | 4 | 3 |
| Overall Study Allocation | Withdrawal by Subject | 9 | 5 |
| Time 3 Measures @ 6 Mth | Lost to Follow-up | 0 | 3 |
| Time 3 Measures @ 6 Mth | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Lifestyle Physical Activity Intervention | Information/Attention Comparison |
|---|---|---|---|
| Abdominal Aortic Aneurysm No | 120 Participants | 59 Participants | 61 Participants |
| Abdominal Aortic Aneurysm Yes | 1 Participants | 0 Participants | 1 Participants |
| Age, Continuous | 69.1 years STANDARD_DEVIATION 6.5 | 69.9 years STANDARD_DEVIATION 6.1 | 68.3 years STANDARD_DEVIATION 6.8 |
| Cardiovascular Disease History No | 100 Participants | 51 Participants | 49 Participants |
| Cardiovascular Disease History Yes | 21 Participants | 8 Participants | 13 Participants |
| Cholesterol check in last 2 years DK | 4 Participants | 3 Participants | 1 Participants |
| Cholesterol check in last 2 years No | 4 Participants | 3 Participants | 1 Participants |
| Cholesterol check in last 2 years Yes | 113 Participants | 53 Participants | 60 Participants |
| Currently works outside the home No | 83 Participants | 36 Participants | 47 Participants |
| Currently works outside the home Yes | 38 Participants | 23 Participants | 15 Participants |
| employment status Full time (40 hours/week) | 19 Participants | 10 Participants | 9 Participants |
| employment status No/Not Answered for 1 | 84 Participants | 37 Participants | 47 Participants |
| employment status Part time | 18 Participants | 12 Participants | 6 Participants |
| Family hx: heart attack or stroke No | 47 Participants | 22 Participants | 25 Participants |
| Family hx: heart attack or stroke Yes | 74 Participants | 37 Participants | 37 Participants |
| Family hx: High Blood Pressure No | 30 Participants | 14 Participants | 16 Participants |
| Family hx: High Blood Pressure Yes | 91 Participants | 45 Participants | 46 Participants |
| Follows heart-healthy or low fat/sodium diet No | 83 Participants | 36 Participants | 47 Participants |
| Follows heart-healthy or low fat/sodium diet Yes | 38 Participants | 23 Participants | 15 Participants |
| Heart Diseases/Angina No | 110 Participants | 53 Participants | 57 Participants |
| Heart Diseases/Angina Yes | 11 Participants | 6 Participants | 5 Participants |
| High Cholesterol No | 62 Participants | 26 Participants | 36 Participants |
| High Cholesterol Yes | 59 Participants | 33 Participants | 26 Participants |
| Highest Grade Level College Graduate | 22 Participants | 12 Participants | 10 Participants |
| Highest Grade Level Grade School | 0 Participants | 0 Participants | 0 Participants |
| Highest Grade Level Graduate School | 20 Participants | 9 Participants | 11 Participants |
| Highest Grade Level HS Graduate/GED | 14 Participants | 4 Participants | 10 Participants |
| Highest Grade Level Some College | 51 Participants | 30 Participants | 21 Participants |
| Highest Grade Level Some HS | 5 Participants | 3 Participants | 2 Participants |
| Highest Grade Level Vocation or Trade School | 9 Participants | 1 Participants | 8 Participants |
| History of Diabetes/Borderline Diabetes No | 91 Participants | 44 Participants | 47 Participants |
| History of Diabetes/Borderline Diabetes Yes | 30 Participants | 15 Participants | 15 Participants |
| History of High Blood Pressure No | 35 Participants | 15 Participants | 20 Participants |
| History of High Blood Pressure Yes | 86 Participants | 44 Participants | 42 Participants |
| Kidney or Renal Failure No | 119 Participants | 57 Participants | 62 Participants |
| Kidney or Renal Failure Yes | 2 Participants | 2 Participants | 0 Participants |
| Major provider of care for another person No | 98 Participants | 46 Participants | 52 Participants |
| Major provider of care for another person Yes | 23 Participants | 13 Participants | 10 Participants |
| My living status Live alone | 41 Participants | 20 Participants | 21 Participants |
| My living status Live with children/relative/friend | 22 Participants | 10 Participants | 12 Participants |
| My living status Married (live with spouse) | 58 Participants | 29 Participants | 29 Participants |
| No History of Relevant Issues No | 99 Participants | 50 Participants | 49 Participants |
| No History of Relevant Issues Yes | 22 Participants | 9 Participants | 13 Participants |
| Number of people in household 0 | 3 Participants | 0 Participants | 3 Participants |
| Number of people in household 1 | 53 Participants | 26 Participants | 27 Participants |
| Number of people in household 2 | 57 Participants | 29 Participants | 28 Participants |
| Number of people in household 3 | 6 Participants | 3 Participants | 3 Participants |
| Number of people in household 4 | 1 Participants | 1 Participants | 0 Participants |
| Number of people in household 5 | 1 Participants | 0 Participants | 1 Participants |
| Peripheral Vascular Diseases (Poor Circulation) No | 113 Participants | 58 Participants | 55 Participants |
| Peripheral Vascular Diseases (Poor Circulation) Yes | 8 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 42 Participants | 17 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 77 Participants | 40 Participants | 37 Participants |
| Sex/Gender, Customized Female | 121 Participants | 59 Participants | 62 Participants |
| Smoker Category 1_Current Smoker | 9 Participants | 3 Participants | 6 Participants |
| Smoker Category 2_Past Smoker | 41 Participants | 20 Participants | 21 Participants |
| Smoker Category 3_Non-Smoker, with 2nd-Hand Exposure | 49 Participants | 25 Participants | 24 Participants |
| Smoker Category 4_Non-Smoker, without 2nd-Hand Exposure | 22 Participants | 11 Participants | 11 Participants |
| Stroke No | 116 Participants | 57 Participants | 59 Participants |
| Stroke Yes | 5 Participants | 2 Participants | 3 Participants |
| Total Household Yearly Income 10-20K | 18 Participants | 8 Participants | 10 Participants |
| Total Household Yearly Income <10K | 10 Participants | 4 Participants | 6 Participants |
| Total Household Yearly Income 20K-30K | 23 Participants | 12 Participants | 11 Participants |
| Total Household Yearly Income 30K-40K | 18 Participants | 9 Participants | 9 Participants |
| Total Household Yearly Income 40-50K | 14 Participants | 6 Participants | 8 Participants |
| Total Household Yearly Income >50K | 30 Participants | 14 Participants | 16 Participants |
| Total Household Yearly Income Refused/DK | 8 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 62 |
| other Total, other adverse events | 0 / 59 | 0 / 62 |
| serious Total, serious adverse events | 0 / 59 | 1 / 62 |
Outcome results
Primary
Accelerometer Vector Magnitude Counts
motion data counts calculated from three axes
Time frame: 3 and 6 months
Population: Number of participants with completed data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Physical Activity Motivational Interviewing Counseling INTERV | Accelerometer Vector Magnitude Counts | 3 Months | 345,000 Vector Magnitude Counts |
| Physical Activity Motivational Interviewing Counseling INTERV | Accelerometer Vector Magnitude Counts | 6 months | 324,000 Vector Magnitude Counts |
| Information/Attention Without Counseling CONTROL | Accelerometer Vector Magnitude Counts | 3 Months | 324,000 Vector Magnitude Counts |
| Information/Attention Without Counseling CONTROL | Accelerometer Vector Magnitude Counts | 6 months | 309,000 Vector Magnitude Counts |
p-value: 0.023ANCOVA
Secondary
Step of Counts (Per Day)
Number of steps that a person takes per day
Time frame: 3 and 6 months
Population: Attrition of 5 participants
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Physical Activity Motivational Interviewing Counseling INTERV | Step of Counts (Per Day) | 3 month | 3982 Steps per day |
| Physical Activity Motivational Interviewing Counseling INTERV | Step of Counts (Per Day) | 6 month | 3783 Steps per day |
| Information/Attention Without Counseling CONTROL | Step of Counts (Per Day) | 3 month | 3476 Steps per day |
| Information/Attention Without Counseling CONTROL | Step of Counts (Per Day) | 6 month | 3160 Steps per day |
p-value: 0.011ANCOVA
Other Pre-specified
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.
Time frame: Baseline, 3mths, 6mths
Population: 8 participants withdrew from the control group and 13 withdrew from the PA intervention at 3 months. At 6 months 5 participants withdrew from the control group and no withdrawals from the PA intervention group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Activity Motivational Interviewing Counseling INTERV | Self-Efficacy | Baseline | 7.8 mean score on a (0-10) scale | Standard Deviation 2.4 |
| Physical Activity Motivational Interviewing Counseling INTERV | Self-Efficacy | 3-month | 7.7 mean score on a (0-10) scale | Standard Deviation 1.5 |
| Physical Activity Motivational Interviewing Counseling INTERV | Self-Efficacy | 6- month | 7.2 mean score on a (0-10) scale | Standard Deviation 2.3 |
| Information/Attention Without Counseling CONTROL | Self-Efficacy | Baseline | 7.0 mean score on a (0-10) scale | Standard Deviation 2.3 |
| Information/Attention Without Counseling CONTROL | Self-Efficacy | 3-month | 5.9 mean score on a (0-10) scale | Standard Deviation 2.1 |
| Information/Attention Without Counseling CONTROL | Self-Efficacy | 6- month | 5.9 mean score on a (0-10) scale | Standard Deviation 2.3 |
p-value: 0.033Wilcoxon (Mann-Whitney)
Other Pre-specified
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
Time frame: Baseline, 3 and 6 months
Population: 8 participants withdrew from the control group and 13 withdrew from the PA intervention at 3 months. At 6 months 5 participants withdrew from the control group and no withdrawals from the PA intervention group
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | Baseline SOC | Action | 1 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | 3 Month SOC | Preparation | 4 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | Baseline SOC | Pre-Contemplation | 9 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | 3 Month SOC | Action | 36 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | Baseline SOC | Maintenance | 0 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | 6 month SOC | Pre-Contemplation | 2 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | Baseline SOC | Preparation | 48 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | 6 month SOC | Contemplation | 1 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | 3 Month SOC | Pre-Contemplation | 0 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | 6 month SOC | Preparation | 2 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | Baseline SOC | Contemplation | 1 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | 6 month SOC | Action | 0 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | 6 month SOC | Maintenance | 41 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | 3 Month SOC | Contemplation | 0 Participants |
| Physical Activity Motivational Interviewing Counseling INTERV | Stage of Change (SOC) | 3 Month SOC | Maintenance | 6 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | 6 month SOC | Action | 5 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | 3 Month SOC | Maintenance | 5 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | Baseline SOC | Pre-Contemplation | 7 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | Baseline SOC | Contemplation | 5 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | Baseline SOC | Preparation | 50 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | Baseline SOC | Action | 0 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | Baseline SOC | Maintenance | 0 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | 3 Month SOC | Pre-Contemplation | 3 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | 3 Month SOC | Contemplation | 1 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | 3 Month SOC | Preparation | 17 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | 3 Month SOC | Action | 28 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | 6 month SOC | Pre-Contemplation | 3 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | 6 month SOC | Contemplation | 4 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | 6 month SOC | Preparation | 13 Participants |
| Information/Attention Without Counseling CONTROL | Stage of Change (SOC) | 6 month SOC | Maintenance | 24 Participants |
p-value: 0.001Cochran-Mantel-Haenszel