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School of Nursing
Center for Gerontological Nursing
A Randomized Trial of Exercise, Education, and Risk Reduction Counseling to Prevent Falls in a
Population-Based Sample of Older Women
Jean F. Wyman, PhD, RNCynthia R. Gross, PhD
Richard P. DiFabio, PhD, PTRuth A. Lindquist, PhD, RN
Teresa C. McCarthy, MDJohn A. Nyman, PhD
Michael G. Wade, PhDMary J. Findorff, PhD, RNJoseph A. Konstan, PhD
Center for Gerontological Nursing
Acknowledgments• National Institute of Nursing Research and Office of
Women’s Health Research, National Institutes of Health (R01 NR05107)
• School of Nursing, University of Minnesota
Center for Gerontological Nursing
Research TeamCo-Investigators• Cynthia R. Gross, PhD• Richard P. DiFabio, PhD, PT• Joseph A. Konstan, PhD• Ruth A. Lindquist, PhD, RN• Teresa C. McCarthy, MD• John A. Nyman, PhD• Michael G. Wade, PhD
Other Team Members• Mary J. Findorff, PhD, RN• Nancy Nachreiner, PhD, RN• Jennifer Peters, PhD, RN• Holly Stock, MS, MA• Helen Reid, MS
• Melinda Monigold, MS, FNP• Kristine Talley, MS, GNP• Catherine Croghan, BSN, MS• Lois Gildea, BSN, RN• Carrie Gomez, BSN, RN• Mary Edwards, BSN, RN• Jenny Cristobal• Mary Eichten• Kelly Hughes• Allison Mumbleau• Sean Lamb-Vosen• Sonja Theobald, BS• Pat Minor, BA
Center for Gerontological Nursing
Background• Falls are a prevalent, serious, and costly problem
affecting older adults, particularly older women
• Multifactorial interventions conducted by a multidisciplinary team that include exercise and are targeted to high risk individuals are recommended to prevent falls
• Most fall prevention studies have been based on convenience samples limiting understanding of how these interventions work in the general population
• Further research is needed to test strategies that will be effective in reducing falls in at-risk populations
Center for Gerontological Nursing
Aim• Test the efficacy of a multifactorial fall prevention
program in reducing falls in a population-based sample of community-dwelling older women deemed at risk for falling
- Primary Hypothesis:
• Participants in the fall prevention program will experience fewer falls than those in a health education program (attention control)
- Secondary Hypothesis
• Participants in the fall prevention program will have fewer fall-related injuries
Center for Gerontological Nursing
Design
• Randomized controlled, single-blinded trial with 2-arms
- Multifactorial fall prevention program
- General health education program (control)
• Probability-based sample involving mailed invitations to female Medicare enrollees within 12 mile radius of University
• Age-stratified randomization using permutated block design
• Baseline with 1-year of monthly follow-up
• Modest honorarium ($25 per assessment visit)
Center for Gerontological Nursing
Eligibility Criteria• Female Medicare beneficiaries ≥ 70 years • Reside outside a nursing home• Mentally intact (MMSE > 23)• Able to walk 30 feet without stopping with/without
assistive device• Evidence of postural instability and minimum of one
other injurious fall risk factor• Not currently involved in regular exercise• Free from conditions that would prohibit safe,
independent exercise • Physician clearance for exercise participation• Be able to read and understand English• Have touch-tone phone service
Center for Gerontological Nursing
Baseline Evaluation• History and Physical Exam
• Mini-Mental State Exam
• Berg Balance Test
• Timed Get-Up and Go Test
• 8-Foot Timed Walk
• Timed Chair Elevations
• Tandem Walk
• Hip Strength
• Modified Home Environmental Survey
• Lubben’s Social Network Scale
• SF-36 Health Survey
• Cantril Self-Anchoring Scale
• Geriatric Depression Scale
• Risk-Taking Questionnaire
• Physical Activity Scale for the Elderly
• Fear of Falling
- SAFE- ABC Scale
• Exercise Stage of Adoption, Self-Efficacy, Decision Balance, and Processes of Change Scales
Center for Gerontological Nursing
Intervention Components- 28 week program in two phases:
• 12 weeks, alternating biweekly home visits and telephone calls by baccalaureate-prepared registered nurses
• 16 weeks, tapered interactive computerized telephone support and monitoring
- Instructional manual
Fall Prevention Program• Based upon Transtheoretical Model of Behavior
Change and empirical findings
• Comprehensive risk assessment by nurse practitioner
• Exercise program
- Graded walking program (30 minutes for minimum 5 days/week)
- Balance, strength, and coordination exercises (11 exercises; 12 repetitions; weighted belt in selected exercises; minimum 2 days/week)
• Fall prevention education
• Tailored risk reduction counseling using action plan
• Exercise relapse prevention strategies
• Provision of 2 nightlights
Center for Gerontological Nursing
Falls Definition and Measurement
• Fall Definition:
- Unintentional event that results in a person coming to rest on a lower level, other than as a consequence of sustaining a violent blow, loss of consciousness, sudden onset of paralysis, or an epileptic seizure (Kellogg International Workgroup, 1987)
• Prospective Measurement:
- Daily fall calendar mailed in monthly with follow-up telephone interview on all falls reported
Center for Gerontological Nursing
Injury Event Definitions• Minor
- Abrasions, soft tissue injuries, lacerations not requiring sutures, and sprains
• Moderate
- Injuries resulting in evaluation or treatment by a health care provider,diagnostic tests such as x-rays, or resulting in 3 day activity restriction
• Major
- Fractures, head injuries resulting in hospitalization, joint dislocations, lacerations requiring sutures
• If multiple injuries sustained for same injury event, classification based on the most severe rating
Assessed for eligibility(N=4112)
Eligible and Randomized
(N=272)
Excluded (n=3840)Non response (n=1332)Ineligible (n=1200)Refused (n=965)Other (n=343)
Allocated to Fall Prevention (n=137)
12-Week AssessmentComplete (n=131)Withdrawals (n=6)
Allocated to Health Education (n=135)
12-Week AssessmentComplete (n=132)Withdrawals (n=3)
1-Year AssessmentComplete (n=127)Withdrawals (n=9)Deaths (n=1)
1-Year AssessmentComplete (n=130)Withdrawals (n=4)Deaths (n=1)
Study Flow
Center for Gerontological Nursing
Sample Characteristics (N=272)Characteristic Fall Prevention
(N=137)N (%) or M ± SD
Health Education(N=135)
N (%) or M ±SD
Baseline age 78.5 ±5.3 79.0 ±5.9
White 133(97.1) 135(100)
Lives alone 68(49.6) 65(48.1)
≥ High School Education 85(62.0) 78(57.8)
Income ≥ $20,000/year 76(55.5) 64(47.4)
History of falling in past year 52(38.0) 54(40.0)
# Chronic conditions 2.6±1.6 2.9 ±1.6
# Weekly prescription drugs 3.5 ±2.5 3.8 ±2.6
SF-36 Physical function 61.2 ±23.2 63.2 ±20.9
Very good or excellent self-rated health 46(33.6) 50(37.0)
Geriatric Depression Scale Score 1.9 ±2.1 1.7 ±2.3
Center for Gerontological Nursing
Sample Characteristics (N=272)
Characteristic Fall Prevention(N=137)
N(%) or M ± SD
Health Education(N=135)
N (%) or M ± SDMini-Mental State Exam Score 28.5±1.5 28.1±5.9
Body mass index 28.1±5.4 28.1±5.9Use of assistive device 25(18.2) 33(24.4)Berg Balance Test 48.9±5.7 48.9±5.5
8-foot timed walk (seconds) 3.1±1.9 2.9±1.4Timed chair elevations (seconds) 16.0±6.1 15.6±5.7Timed Up and Go Test (seconds) 13.1±11.4 12.1±4.2Hip Strength 130.9±41.7 136.1±43.3
Center for Gerontological Nursing
Fall Frequency at 1 Year
0
20
40
60
80
100
0 1 2 3 4 or More
Number of Falls
Number of Participants
Fall Prevention Health Education
Center for Gerontological Nursing
Fall Outcomes Over 1-YearOutcome Fall Prevention
(N=131)Health Education
(N=132)
Number of falls 84 119
Number of nonfallers (%) 77(56.2) 72(53.3)
Number of fallers (%) 54(41.2) 60(45.5)
Number of repeat fallers (%) 14 (10.7) 24 (18.2)
Number of injurious fallers* (%) 14 (10.7) 18 (13.6)
Number of single, injurious fallers* (%)
13(9.9) 15(11.4)
Number of multiple, injurious fallers* (%)
1(.8) 3(2.3)
Time to first fall in days (M±SD) 173.9 ± 130.7 150.8 ± 148.9
*Includes moderate and severe injuries
Center for Gerontological Nursing
Fall Rate Per 100 Person Years
Fall Prevention Health Education
Fall rate per 100 person years* 63.7 88.8
Incidence Rate Ratio: 0.717 (95% CI: 0.535-0.955)
*P < .01
Center for Gerontological Nursing
Type of Injury
0
10
20
30
40
50
60
70
80
None Minor Moderateor Severe
Number of Falls
Fall Prevention (84 falls)
Health Education (119 falls)
0
1
2
3
4
5
6
7
8
9
FallPrevention
HealthEducation
Number of Falls
Number of Falls Resulting in Peripheral Fractures
Severity of Injury
Model Predicting Efficacy of the Fall Prevention
Program (Negative Binomial Regression) Variable Incidence Rate Ratio
(95% Confidence Interval)
Fall prevention group assignment 0.65 (0.46-0.94)*
Age 0.96 (0.93-1.00)*
Number of falls in past year 1.31 (1.07-1.61)**
Weekly urinary incontinence 2.51 (1.12-5.66)*
Number of prescription drugs associated with fall risk
1.26 (1.07-1.47)*
Education, high school and below 0.66 (0.45-0.96)*
Cardiovascular disease 0.48 (0.30-0.76)**
Severe hearing loss 1.51 (0.98-2.34)
Poor visual acuity 2.33 (1.00-5.42)*
Past stroke requiring hospitalization 2.85 (1.33-6.08)*
*P < .05**P < .01
Center for Gerontological Nursing
Conclusions• In a population-based sample of at-risk older
women, a home program involving simple exercise, education, and tailored risk reduction counseling was effective in reducing falls
• Falls were reduced by 35%
• This program also led to fewer major injuries, although the significance of this finding was influenced by low power
• Results indicate that a multifactorial fall prevention program implemented by nurses can be effective in fall prevention
Center for Gerontological Nursing
Conclusions• Future research will report on longer-term
outcomes, the cost-effectiveness of the intervention, and the effect of the intervention on other secondary outcomes
Recommended