Community-based Intervention Effects on Older Adults' Physical Activity and Falls (R01)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 309
- Locations
- 1
- Primary Endpoint
- Quantity of Physical Activity Measured Objectively
Study Overview
Brief Summary
The research team will conduct a 2 x 2 factorial experiment testing the individual and combined effects of two empirically and theoretically relevant sets of behavior change strategies on community-dwelling older adults' physical activity. To do this the investigators will randomize participants >= 70 years old (n = 308) to 1 of 4 experimental conditions. All conditions include an evidence-based physical activity protocol endorsed by Centers for Disease Control and Prevention (CDC) for use by all older adults, including those with frailty and multiple co-morbidities and the commercially available physical activity monitor (e.g., Fitbit) to augment intervention delivery. Intervention components that are experimental and vary by condition are the sets of behavior change strategies which will be combined with the physical activity protocol and the physical activity monitor. Condition 1 has no specific behavior change strategies; Condition 2 includes an intervention component comprised of 5 interpersonal behavior change strategies, such as facilitating social support and social comparison; Condition 3 includes an intervention component comprised of 5 intrapersonal behavior change strategies, such as setting personally meaningful goals; and Condition 4 includes both sets of behavior change strategies -- 5 interpersonal strategies combined with 5 intrapersonal behavior change strategies.
Detailed Description
To fully examine the effects of these experimental components, The investigators have delineated Primary, Secondary and Exploratory Aims:
Primary Aim: Determine which experimental intervention component(s) increase PA among community-dwelling older adults post-intervention: immediately, 6 months, and 12 months. Hypothesis: Participants receiving the interpersonal set of behavior change strategies (conditions 2 and 4) will have clinically meaningful increases in PA post- intervention (at all 3 time-points), compared to participants not receiving these strategies (conditions 1 and 3).
Secondary Aim: Determine which experimental intervention component(s)decrease fall occurrence and increase quality of life (QOL) among community-dwelling older adults 12 months post-intervention. Hypotheses: Participants receiving the set of interpersonal behavior change strategies will have clinically meaningful reductions in falls and increases in QOL, 12 months post-intervention, compared to participants not receiving these strategies.
Exploratory Aim: Evaluate experimental intervention component effects on targeted psychosocial constructs (social support; readiness; self-regulation) and physical constructs (functional leg strength and balance), which are theorized as mechanisms of change--and whether these mechanisms mediate the effects of experimental intervention components on PA and falls. Hypotheses: Receiving the interpersonal behavioral change strategies, relative to not receiving these strategies, will elicit increases in targeted psychosocial constructs and increases in physical constructs, which in turn will mediate the intervention's effects on PA behavior and falls.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
The specific content of the intervention condition/arm that is assigned to each participant will be masked from data collectors/outcome assessors.
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •≥70 years of age
- •English speaking
- •Low levels of PA (below recommended guidelines)
- •Self-reported fall risk as guided by the CDC, Steadi fall risk screener
- •One or more falls in the last year
- •Unsteadiness when standing or walking
- •Worries about falling
- •Participants who self-report the following symptoms will require clearance from a primary provider (as guided by the Exercise and Screening for You Questionnaire)
- •Pain, tightness or pressure in chest during PA (walking, climbing stairs, household chores, similar activities) that have not been checked and/ or treated by a healthcare provider
- •Current dizziness that have not been checked and/ or treated by a healthcare provider
- •Current, frequent falls that have not been checked and/ or treated by a healthcare provider
Exclusion Criteria
- •Lower extremity injury or surgery within the past 6 weeks
- •Inability to walk
- •Formal diagnosis of neurocognitive impairment or dementia
Arms & Interventions
Otago+PAM+Health / Wellness topics
Condition 1:
Otago Exercise Program adapted for delivery to small groups; a physical activity monitor such as a Fitbit (PAM); and, information about health and wellness (8) topics guided by content in the National Institute on Aging (NIA) and Centers for Disease Control and Prevention websites.
Intervention: Otago Exercise Program (Behavioral)
Otago+PAM+Health / Wellness topics
Condition 1:
Otago Exercise Program adapted for delivery to small groups; a physical activity monitor such as a Fitbit (PAM); and, information about health and wellness (8) topics guided by content in the National Institute on Aging (NIA) and Centers for Disease Control and Prevention websites.
Intervention: Physical activity monitors (e.g., Fitbit) (Device)
Otago+PAM+Health / Wellness topics
Condition 1:
Otago Exercise Program adapted for delivery to small groups; a physical activity monitor such as a Fitbit (PAM); and, information about health and wellness (8) topics guided by content in the National Institute on Aging (NIA) and Centers for Disease Control and Prevention websites.
Intervention: Information about Health and Wellness (Other)
Otago + PAM + Interpersonal strategies
Condition 2:
Otago Exercise Program adapted for delivery to small groups; a PAM (e.g.,Fitbit); 5 Interpersonal behavior change strategies; and, information about health and wellness topics (1) guided by content in the National Institute on Aging (NIA) and Centers for Disease Control and Prevention websites.
Intervention: Physical activity monitors (e.g., Fitbit) (Device)
Otago + PAM + Interpersonal strategies
Condition 2:
Otago Exercise Program adapted for delivery to small groups; a PAM (e.g.,Fitbit); 5 Interpersonal behavior change strategies; and, information about health and wellness topics (1) guided by content in the National Institute on Aging (NIA) and Centers for Disease Control and Prevention websites.
Intervention: Otago Exercise Program (Behavioral)
Otago + PAM + Interpersonal strategies
Condition 2:
Otago Exercise Program adapted for delivery to small groups; a PAM (e.g.,Fitbit); 5 Interpersonal behavior change strategies; and, information about health and wellness topics (1) guided by content in the National Institute on Aging (NIA) and Centers for Disease Control and Prevention websites.
Intervention: Interpersonal Behavior Change Strategies (Behavioral)
Otago, PAM, Intrapersonal strategies
Condition 3:
Otago Exercise Program adapted for delivery to small groups; a PAM (e.g.,Fitbit); 5 Intrapersonal behavior change strategies; and, health and wellness topics (1) guided by content in the National Institute on Aging (NIA) and Centers for Disease Control and Prevention websites.
Intervention: Otago Exercise Program (Behavioral)
Otago, PAM, Intrapersonal strategies
Condition 3:
Otago Exercise Program adapted for delivery to small groups; a PAM (e.g.,Fitbit); 5 Intrapersonal behavior change strategies; and, health and wellness topics (1) guided by content in the National Institute on Aging (NIA) and Centers for Disease Control and Prevention websites.
Intervention: Physical activity monitors (e.g., Fitbit) (Device)
Otago, PAM, Intrapersonal strategies
Condition 3:
Otago Exercise Program adapted for delivery to small groups; a PAM (e.g.,Fitbit); 5 Intrapersonal behavior change strategies; and, health and wellness topics (1) guided by content in the National Institute on Aging (NIA) and Centers for Disease Control and Prevention websites.
Intervention: Intrapersonal Behavior Change Strategies (Behavioral)
Otago,PAM, Inter+Intra strategies
Condition 4:
Otago Exercise Program adapted for delivery to small groups; a PAM (e.g., Fitbit); 5 Interpersonal behavior change strategies; and, 5 Intrapersonal behavior change strategies
Intervention: Physical activity monitors (e.g., Fitbit) (Device)
Otago,PAM, Inter+Intra strategies
Condition 4:
Otago Exercise Program adapted for delivery to small groups; a PAM (e.g., Fitbit); 5 Interpersonal behavior change strategies; and, 5 Intrapersonal behavior change strategies
Intervention: Otago Exercise Program (Behavioral)
Otago,PAM, Inter+Intra strategies
Condition 4:
Otago Exercise Program adapted for delivery to small groups; a PAM (e.g., Fitbit); 5 Interpersonal behavior change strategies; and, 5 Intrapersonal behavior change strategies
Intervention: Interpersonal Behavior Change Strategies (Behavioral)
Otago,PAM, Inter+Intra strategies
Condition 4:
Otago Exercise Program adapted for delivery to small groups; a PAM (e.g., Fitbit); 5 Interpersonal behavior change strategies; and, 5 Intrapersonal behavior change strategies
Intervention: Intrapersonal Behavior Change Strategies (Behavioral)
Outcomes
Primary Outcomes
Quantity of Physical Activity Measured Objectively
Time Frame: Baseline and Post-Intervention (one week, six months, twelve months)
Average weekly minutes of total physical activity per week (light, moderate and vigorous intensities) as captured from PAM data (Fitbit Charge-2)
Physical Activity Scale for the Elderly (PASE)
Time Frame: Baseline and Post-Intervention (one week, six months, twelve months)
Self-report Measure of Physical Activity. PASE is a validated questionnaire to measure the amount of physical activity in people over the age of 65 including types (e.g., walking, recreational, exercise, housework, care-giving). Scores, accounting for frequency, duration and intensity of physical activity are calculated and typically range from 0 to 793, with higher value representing more physical activity.
Secondary Outcomes
- Fall Rate(12 months post intervention)
- Number of Participants With Moderate or Major Injuries From Falls(12 months post intervention)
- Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health(Baseline and post-intervention: one-week, six months, and 12 months)