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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR016705-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Otago+PAM+Health / Wellness topics | Active Comparator | 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. |
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| Otago + PAM + Interpersonal strategies | Experimental | 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. |
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| Otago, PAM, Intrapersonal strategies | Experimental | 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. |
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| Otago,PAM, Inter+Intra strategies |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Otago Exercise Program | Behavioral | 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. |
| 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) |
| 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. |
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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
Participants who self-report the following symptoms will require clearance from a primary provider (as guided by the Exercise and Screening for You Questionnaire)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siobhan K McMahon, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota - School of Nursing | Minneapolis | Minnesota | 55408 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38421648 | Derived | McMahon SK, Lewis BA, Guan W, Wang Q, Hayes SM, Wyman JF, Rothman AJ. Effect of Intrapersonal and Interpersonal Behavior Change Strategies on Physical Activity Among Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e240298. doi: 10.1001/jamanetworkopen.2024.0298. |
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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
November 17, 2017 to September 2, 2022
IRB approval
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| ID | Title | Description |
|---|---|---|
| FG000 | Otago+PAM+Health / Wellness Topics | Condition 1: Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2023 |
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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.
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The specific content of the intervention condition/arm that is assigned to each participant will be masked from data collectors/outcome assessors.
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 |
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| Physical activity monitors (e.g., Fitbit) | Device | 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. |
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| Interpersonal Behavior Change Strategies | Behavioral | 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. |
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| Intrapersonal Behavior Change Strategies | Behavioral | 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 |
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| Information about Health and Wellness | Other | 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. |
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| 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 |
| FG001 | Otago + PAM + Interpersonal Strategies | Condition 2:
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| FG002 | Otago, PAM, Intrapersonal Strategies | Condition 3:
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| FG003 | Otago,PAM, Inter+Intra Strategies | Condition 4:
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Otago+PAM+Health / Wellness Topics | Condition 1:
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| BG001 | Otago + PAM + Interpersonal Strategies | Condition 2:
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| BG002 | Otago, PAM, Intrapersonal Strategies | Condition 3:
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| BG003 | Otago,PAM, Inter+Intra Strategies | Condition 4:
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| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Number analyzed at baseline and post-intervention (one week, six months, twelve months) represent the number of participants in the study at that time. Numbers decrease across longitudinal time points due to participant withdrawal or loss to follow up | Posted | Mean | Standard Deviation | minutes per day | Baseline and Post-Intervention (one week, six months, twelve months) |
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| Primary | 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. | Number analyzed at baseline and post-intervention (one week, six months, twelve months) represent the number of participants in the study at that time. Numbers decrease across longitudinal time points due to participant withdrawal or loss to follow up | Posted | Mean | Standard Error | Total PASE Score | Baseline and Post-Intervention (one week, six months, twelve months) |
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| Secondary | Fall Rate | Falls per person year, assessed via prospective monthly calendars | Posted | Number | Falls per person year | 12 months post intervention |
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| Secondary | 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. | Posted | Number | Participants | 12 months post intervention |
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| Secondary | 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. | Number analyzed at baseline and post-intervention (one week, six months, twelve months) represent the number of participants in the study at that time. Numbers decrease across longitudinal time points due to participant withdrawal or loss to follow up | Posted | Mean | Standard Deviation | T score | Baseline and post-intervention: one-week, six months, and 12 months |
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12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Otago+PAM+Health / Wellness Topics | Condition 1:
| 1 | 77 | 0 | 77 | 2 | 77 |
| EG001 | Otago + PAM + Interpersonal Strategies | Condition 2:
| 2 | 76 | 0 | 76 | 7 | 76 |
| EG002 | Otago, PAM, Intrapersonal Strategies | Condition 3:
| 1 | 74 | 0 | 74 | 3 | 74 |
| EG003 | Otago,PAM, Inter+Intra Strategies | Condition 4:
| 0 | 75 | 2 | 75 | 3 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cancer | General disorders | Systematic Assessment |
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| Stroke | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Pain | General disorders | Systematic Assessment |
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| Fall | General disorders | Systematic Assessment |
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| fracture | General disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Polymyalgia rheumatica--unrelated | General disorders | Systematic Assessment |
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| cancer | General disorders | Systematic Assessment |
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| lung illness | General disorders | Systematic Assessment |
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| hyponatremia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Siobhan McMahon | University of Minnesota | 612-625-3225 | skmcmaho@umn.edu |
| Feb 27, 2024 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2023 | Feb 27, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
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| D006262 | Health |
| ID | Term |
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| D011154 | Population Characteristics |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| one week post-intervention |
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| six months post-intervention |
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| twelve months post-intervention |
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Condition 2:
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| OG002 | Otago, PAM, Intrapersonal Strategies | Condition 3:
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| OG003 | Otago,PAM, Inter+Intra Strategies | Condition 4:
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| OG002 | Otago, PAM, Intrapersonal Strategies | Condition 3:
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| OG003 | Otago,PAM, Inter+Intra Strategies | Condition 4:
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Condition 2:
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| OG002 | Otago, PAM, Intrapersonal Strategies | Condition 3:
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| OG003 | Otago,PAM, Inter+Intra Strategies | Condition 4:
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| OG001 | Otago + PAM + Interpersonal Strategies | Condition 2:
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| OG002 | Otago, PAM, Intrapersonal Strategies | Condition 3:
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| OG003 | Otago,PAM, Inter+Intra Strategies | Condition 4:
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