N/A
N=309
Community-based Intervention Effects on Older Adults' Physical Activity
Exercise · Physical Activity · Accidental Fall · Motivation · Older Adults
Bottom Line
View on ClinicalTrials.gov: NCT03326141 ↗Enrolled (actual)
309
Serious AEs
0.7%
Results posted
Apr 2024
Primary outcome: Primary: Quantity of Physical Activity Measured Objectively — 177.9; 167.7; 185.9; 177.9 minutes per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Otago Exercise Program (Behavioral); Physical activity monitors (e.g., Fitbit) (Device); Interpersonal Behavior Change Strategies (Behavioral); Intrapersonal Behavior Change Strategies (Behavioral); Information about Health and Wellness (Other)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantity of Physical Activity Measured Objectively |
177.9; 167.7; 185.9; 177.9; 180.5; 193.1 | — |
| PRIMARY Physical Activity Scale for the Elderly (PASE) |
102.2; 108.3; 110.6; 101.8; 111.1; 119.2 | — |
| SECONDARY Fall Rate |
0.9; 1.0; 0.9; 1.1 | — |
| SECONDARY Number of Participants With Moderate or Major Injuries From Falls |
6; 7; 6; 6; 1; 2 | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health |
39.2; 39.5; 39.1; 40; 40.2; 39.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03326141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.