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Community-based Intervention Effects on Older Adults' Physical Activity

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ClinicalTrials.gov Identifier: NCT03326141
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Exercise Physical Activity Accidental Fall Motivation Older Adults Behavioral: Otago Exercise Program Device: Physical activity monitors (e.g., Fitbit) Behavioral: Interpersonal Behavior Change Strategies Behavioral: Intrapersonal Behavior Change Strategies Other: Information about Health and Wellness Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Our 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.
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.
Primary Purpose: Prevention
Official Title: Community-based Intervention Effects on Older Adults' Physical Activity and Falls (R01)
Actual Study Start Date : November 17, 2017
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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.

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, 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 Name: 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

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, 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 Name: 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




Primary Outcome Measures :
  1. Quantity of physical activity measured objectively and via self-report [ Time Frame: Baseline and Post-Intervention: immediately, 6 months, and 12 months ]
    Average weekly minutes of total physical activity per week (light, moderate and vigorous intensities) as captured from PAM data (Fitbit Charge-2) and the Physical Activity Scale for the Elderly (PASE). PASE total scores range from 0-400, with higher value representing more physical activity.


Secondary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, and Post-Intervention: immediate; 6 months, and 12 months ]
    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

  2. Fall and Injury Rate [ Time Frame: Baseline, and Post-Intervention: immediate; 6 months, and 12 months ]
    Will be assessed using prospective monthly fall calendars.

  3. Patient Reported Outcomes Measurement Information System (PROMIS) Global Quality of life [ Time Frame: Baseline and Post-Intervention: immediate; 6 months, and 12 months ]
    This will assess Global Physical Health and Global Mental health. Subscales for each range from 0 to 40, with 40 indicating better perceived physical and mental health, respectively


Other Outcome Measures:
  1. Index of Readiness [ Time Frame: Baseline and Post-Intervention: immediate; 6 months, and 12 months ]
    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.

  2. Self-Efficacy for Exercise Scale [ Time Frame: Baseline and Post-Intervention: immediate; 6 months, and 12 months ]
    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.

  3. Behavioral Regulation in Exercise Questionnaire (BREQ-3) [ Time Frame: Baseline and Post-Intervention: immediate; 6 months, and 12 months ]
    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.

  4. Index of Self-Regulation [ Time Frame: Baseline and Post-Intervention: immediate; 6 months, and 12 months ]
    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.

  5. Chronic Illnesses Resources Survey [ Time Frame: Baseline and Post-Intervention: immediate; 6 months, and 12 months. ]
    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.

  6. Life Space Assessment [ Time Frame: Baseline and Post-Intervention: immediate; 6 months, and 12 months. ]
    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").

  7. Modified Group Cohesion Questionnaire [ Time Frame: Baseline and Post-Intervention: immediate; 6 months, and 12 months. ]
    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.

  8. Brief Pain Inventory [ Time Frame: Baseline and Post-Intervention: immediate; 6 months, and 12 months ]
    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.

  9. Fall risk inducing medications [ Time Frame: Baseline and Post-Intervention: immediate; 6 months, and ]
    Measured through medication inventory and classification of fall risk inducing medications.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326141


Contacts
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Contact: Siobhan K McMahon, PhD 612-625-3225 skmcmaho@umn.edu

Locations
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United States, Minnesota
University of Minnesota - School of Nursing Recruiting
Minneapolis, Minnesota, United States, 55408
Contact: Siobhan K McMahon, PhD    218-290-3422    skmcmaho@umn.edu   
Principal Investigator: Siobhan K McMahon, PhD         
Sponsors and Collaborators
University of Minnesota
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Siobhan K McMahon, PhD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03326141    
Other Study ID Numbers: 1607S90922
1R01NR016705-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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