Community-based Intervention Effects on Older Adults' Physical Activity

Not Applicable

Completed

• Conditions: Accidental Fall; Physical Activity; Older Adults; Exercise; Motivation
• Interventions: Behavioral: Otago Exercise Program; Device: Physical activity monitors (e.g., Fitbit); Behavioral: Interpersonal Behavior Change Strategies; Other: Information about Health and Wellness; Behavioral: Intrapersonal Behavior Change Strategies

• Registration Number: NCT03326141
• Lead Sponsor: University of Minnesota

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 Timeline

• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-31
• Study Start: 2017-11-17
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Results First Submitted: 2024-01-28
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Results First Posted: 2024-04-24
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

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

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Exclusion Criteria

• Lower extremity injury or surgery within the past 6 weeks
• Inability to walk
• Formal diagnosis of neurocognitive impairment or dementia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Otago + PAM + Interpersonal strategies	Physical activity monitors (e.g., Fitbit)	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.
Otago + PAM + Interpersonal strategies	Interpersonal Behavior Change 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.
Otago, PAM, Intrapersonal strategies	Physical activity monitors (e.g., Fitbit)	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.
Otago+PAM+Health / Wellness topics	Otago Exercise Program	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.
Otago + PAM + Interpersonal strategies	Otago Exercise Program	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.
Otago+PAM+Health / Wellness topics	Physical activity monitors (e.g., Fitbit)	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.
Otago+PAM+Health / Wellness topics	Information about Health and Wellness	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.
Otago, PAM, Intrapersonal strategies	Intrapersonal Behavior Change 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.
Otago,PAM, Inter+Intra strategies	Otago Exercise Program	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
Otago,PAM, Inter+Intra strategies	Interpersonal Behavior Change 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
Otago,PAM, Inter+Intra strategies	Intrapersonal Behavior Change 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
Otago, PAM, Intrapersonal strategies	Otago Exercise Program	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.
Otago,PAM, Inter+Intra strategies	Physical activity monitors (e.g., Fitbit)	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

Primary Outcome Measures

Name	Time	Method
Quantity of Physical Activity Measured Objectively	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)	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 Outcome Measures

Name	Time	Method
Fall Rate	12 months post intervention	Falls per person year, assessed via prospective monthly calendars
Number of Participants With Moderate or Major Injuries From Falls	12 months post intervention	Number of injuries from falls was measured via prospective falls calendars mailed to participants monthly with return addressed/stamped envelopes. Circumstances and injuries related to each fall were documented on the calendars. Calendar documentation each fall was verified and detailed through phone conversations between participants and trained research staff. Moderate and Major injuries from falls were categorized according to the Agency for Healthcare Research and Quality with moderate injuries defined as necessitating sutures, skin glue, splinting, and or involving muscle or joint strain. Major injuries were defined as those associated with internal injuries or a need for surgery, casting, traction, or neurological consults.
Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health	Baseline and post-intervention: one-week, six months, and 12 months	Using the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire 1.2. Two constructs from this questionnaire were converted to t scores: self-reported physical health and self-reported mental health. . Mean t scores are 50, which indicates the adult population mean with a standard deviation of 10. Higher t scores are considered better, or healthier, for self-reported physical health and mental health.; No clinically relevant thresholds were described in this study.

Trial Locations

Locations (1)

University of Minnesota - School of Nursing; 🇺🇸 Minneapolis, Minnesota, United States