Community-based Intervention Effects on Older Adults' Physical Activity

Community-based Intervention Effects on Older Adults' Physical Activity and Falls (R01)

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Exercise; Older Adults; Motivation; Accidental Fall
• Intervention / Treatment: Behavioral: Otago Exercise Program; Device: Physical activity monitors (e.g., Fitbit); Other: Information about Health and Wellness; Behavioral: Interpersonal Behavior Change Strategies; Behavioral: 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 Type: Interventional
• Enrollment (Actual): 309
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55408
      • University of Minnesota - School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Otago Exercise Program; The program has been adapted for groups and includes 5 flexibility movements (e.g., back extension and ankle, head, neck, trunk movements), 5 leg strengthening exercises (knee extensor, knee flexor, hip abductor, ankle plantar flexes, ankle dorsiflexes), 12 balance movements (knee bends, backwards walking, walking and turning, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel-toe walking backwards, sit to stand, stair walking), and a walking plan. The number, intensity and duration of movements are individualized according to preference and ability and they are gradually progressed.; Device: Physical activity monitors (e.g., Fitbit); We will use Fitbit Charge 2 (or an equivalent). Features essential for this research include built-in accelerometers that accurately measure steps and physical activity (PA) duration.Participants will have a brief orientation to these during baseline data collection and have the opportunity to return demonstrate. In addition, RAs will be available to help participants troubleshoot, as needed, via telephone and in person, after intervention meetings. Intervention meetings include discussions about the PAMs, but topics vary according to assigned study condition.; Other Names: PAM; Other: Information about Health and Wellness; Information about health and wellness varies in dose, according to time spent in each condition that addresses behavior change. Topics in condition 1 include sleep, vaccinations, supplements, fall risk factors, memory, hearing and pain guided by information for older adults available on the NIA and CDC websites. Topics in conditions 2 and 3 include fall risk factors and sleep. Topics in condition 4 include fall risk factors.
Experimental: 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.	Behavioral: Otago Exercise Program; The program has been adapted for groups and includes 5 flexibility movements (e.g., back extension and ankle, head, neck, trunk movements), 5 leg strengthening exercises (knee extensor, knee flexor, hip abductor, ankle plantar flexes, ankle dorsiflexes), 12 balance movements (knee bends, backwards walking, walking and turning, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel-toe walking backwards, sit to stand, stair walking), and a walking plan. The number, intensity and duration of movements are individualized according to preference and ability and they are gradually progressed.; Device: Physical activity monitors (e.g., Fitbit); We will use Fitbit Charge 2 (or an equivalent). Features essential for this research include built-in accelerometers that accurately measure steps and physical activity (PA) duration.Participants will have a brief orientation to these during baseline data collection and have the opportunity to return demonstrate. In addition, RAs will be available to help participants troubleshoot, as needed, via telephone and in person, after intervention meetings. Intervention meetings include discussions about the PAMs, but topics vary according to assigned study condition.; Other Names: PAM; Behavioral: Interpersonal Behavior Change Strategies; The interpersonal content will include facilitated discussed about including PA into social routines, identifying and problem-solving social and environmental barriers to PA, social support for exercise, and friendly social comparisons about practicing PA outside the small group setting and interpreting/ sharing data.
Experimental: 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.	Behavioral: Otago Exercise Program; The program has been adapted for groups and includes 5 flexibility movements (e.g., back extension and ankle, head, neck, trunk movements), 5 leg strengthening exercises (knee extensor, knee flexor, hip abductor, ankle plantar flexes, ankle dorsiflexes), 12 balance movements (knee bends, backwards walking, walking and turning, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel-toe walking backwards, sit to stand, stair walking), and a walking plan. The number, intensity and duration of movements are individualized according to preference and ability and they are gradually progressed.; Device: Physical activity monitors (e.g., Fitbit); We will use Fitbit Charge 2 (or an equivalent). Features essential for this research include built-in accelerometers that accurately measure steps and physical activity (PA) duration.Participants will have a brief orientation to these during baseline data collection and have the opportunity to return demonstrate. In addition, RAs will be available to help participants troubleshoot, as needed, via telephone and in person, after intervention meetings. Intervention meetings include discussions about the PAMs, but topics vary according to assigned study condition.; Other Names: PAM; Behavioral: Intrapersonal Behavior Change Strategies; The intrapersonal content will include encouragement and guidance to identify baseline PA patterns, develop and refine personally meaningful goals and plans, identify and problem solve personal barriers to staying physically active, integrate PA into personal routines, and monitor goal outcomes
Experimental: 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	Behavioral: Otago Exercise Program; The program has been adapted for groups and includes 5 flexibility movements (e.g., back extension and ankle, head, neck, trunk movements), 5 leg strengthening exercises (knee extensor, knee flexor, hip abductor, ankle plantar flexes, ankle dorsiflexes), 12 balance movements (knee bends, backwards walking, walking and turning, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel-toe walking backwards, sit to stand, stair walking), and a walking plan. The number, intensity and duration of movements are individualized according to preference and ability and they are gradually progressed.; Device: Physical activity monitors (e.g., Fitbit); We will use Fitbit Charge 2 (or an equivalent). Features essential for this research include built-in accelerometers that accurately measure steps and physical activity (PA) duration.Participants will have a brief orientation to these during baseline data collection and have the opportunity to return demonstrate. In addition, RAs will be available to help participants troubleshoot, as needed, via telephone and in person, after intervention meetings. Intervention meetings include discussions about the PAMs, but topics vary according to assigned study condition.; Other Names: PAM; Behavioral: Interpersonal Behavior Change Strategies; The interpersonal content will include facilitated discussed about including PA into social routines, identifying and problem-solving social and environmental barriers to PA, social support for exercise, and friendly social comparisons about practicing PA outside the small group setting and interpreting/ sharing data.; Behavioral: Intrapersonal Behavior Change Strategies; The intrapersonal content will include encouragement and guidance to identify baseline PA patterns, develop and refine personally meaningful goals and plans, identify and problem solve personal barriers to staying physically active, integrate PA into personal routines, and monitor goal outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of Physical Activity Measured Objectively	Average weekly minutes of total physical activity per week (light, moderate and vigorous intensities) as captured from PAM data (Fitbit Charge-2)	Baseline and Post-Intervention (one week, six months, twelve months)
Physical Activity Scale for the Elderly (PASE)	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.	Baseline and Post-Intervention (one week, six months, twelve months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall Rate	Falls per person year, assessed via prospective monthly calendars	12 months post intervention
Number of Participants With Moderate or Major Injuries From Falls	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.	12 months post intervention
Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health	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.	Baseline and post-intervention: one-week, six months, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Regulation in Exercise Questionnaire (BREQ-3)	This instrument measures the extent to which participants' regulation is considered to be amotivation, external motivation, introjected regulation, Identified regulation, integrated regulation, and intrinsic regulation by calculating mean scores for items corresponding to each level of regulation, with higher mean scores indicating orientation toward that level of regulation. Additional a multidimensional score The relative autonomy index, a single score will be derived from the subscales that gives an index of the degree to which respondents feel self-determined. The index is obtained by applying a weighting to each subscale (-3, -2, -1, +1, +2, +3) and then summing these weighted scores.	Baseline and Post-Intervention: immediate; 6 months, and 12 months
Index of Readiness	This measures participants' readiness to engage in physical activity on a regular basis. Total scores range from 0 to 9 with higher scores showing more readiness.	Baseline and Post-Intervention: immediate, 6 months, and 12 months
Self-Efficacy for Exercise Scale	This measures the confidence to engage in exercise at least 3 times per week in the face of common barriers. Total scores will be calculated based on the sum scores for all items, ranging from 0 to 90, with higher scores showing higher confidence.	Baseline and Post-Intervention: immediate, 6 months, and 12 months
Index of Self-Regulation	This assesses re-conditioning, stimulus control and behavioral outcome monitoring related to exercise and physical activity. Total scores will be calculated based on the sum of all items, and range from 0 to 45, with higher scores showing greater self regulation.	Baseline and Post-Intervention: immediate, 6 months, and 12 months
Chronic Illnesses Resources Survey	This survey assesses the extent to which a person uses multi-level resources to stay active. Scores will be based on mean scores across all items, which range from 0 to 5, and across sub-scale items addressing resources that are personal, in the neighborhood, organizational, and in the media (all ranging from 0 to 5) with higher mean scores indicating greater influence of resources.	Baseline and Post-Intervention: immediate, 6 months, and 12 months.
Short Physical Performance Battery (SPPB)	The SPPB is an assessment of functional strength and balance. Total range 0-12, with higher value representing better functional strength and balance. d)Subscales of Balance, Gait, and sit to stand all range from 0 to 4, with higher values representing more functional strength and balance. Total SPPB score ranges from 0 to 12 with higher numbers indicating better functional balance and strength	Baseline, and Post-Intervention: immediate, 6 months, and 12 months
Life Space Assessment	This survey assesses the extent to which a person moves and is mobile in their home, outside their home, in their neighborhood, in their city and outside their city. It is scored by assigning a value to each of the 5 levels and then summing the 5 scores. The level scores are obtained by multiplying the level number (1-5) by a value for independence (2:"no assistance," 1.5:"use of equipment only," 1:"use of another person and/or equipment") times a value for frequency of movement (1:less than once a week, 2:1-3 times each week, 3: 4 - 6 times each week, and 4: daily) (Fig. 2). The instrument scores range from 0 ("totally bed-bound") to 120 ("traveled out of town every day without assistance").	Baseline and Post-Intervention: immediate, 6 months, and 12 months.
Modified Group Cohesion Questionnaire	This questionnaire assesses the extent to which a person believes their physical activity group. In particular, these constructs are assessed: -attractions to the group-social; attractions to the group-task; group integration-social; group integration task. Mean scores for each construct will be calculated, which range from 0 to 9, with higher scores indicating greater cohesion.	Baseline and Post-Intervention: immediate, 6 months, and 12 months.
Brief Pain Inventory	Location and intensity of pain, as well as the extent to which interferes with daily physical, social and emotional function. Pain severity score is calculated by summing items 2-5 and then dividing by 4, with higher scores indicating more pain. Pain interference scores are obtained by summing items 8a, b, c, d, f, g and then dividing those totals by 7, with scores, indicating that pain confers more interference with function.	Baseline and Post-Intervention: immediate, 6 months, and 12 months
Fall risk inducing medications	Measured through medication inventory and classification of fall risk inducing medications.	Baseline and Post-Intervention: immediate, 6 months, and

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Siobhan K McMahon, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2017
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: September 1, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1607S90922; 1R01NR016705-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data from this study, including baseline characteristics and outcome variables, will be shared via Data Repository at the University of Minnesota after March 2024
• IPD Sharing Time Frame: November 17, 2017 to September 2, 2022
• IPD Sharing Access Criteria: IRB approval
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No