An interventional study of Otago Exercise Program and Physical activity monitors (e.g., Fitbit) in Exercise, Physical Activity and Accidental Fall, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by University of Minnesota · Not applicable, Interventional, and Prevention
Among 34 studies in Motor Activity by University of Minnesota — 1 open to participants now, 2 under way, none of them phase 3. Motor Activity · University of Minnesota.
Among the 34 studies in Motor Activity by University of Minnesota, this one is the 8th largest by enrollment of the 33 interventional ones that give a count, is one of 2 that started in 2017, is one of 29 with no phase, and was the 20th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →1 of the 34 studies in Motor Activity by University of Minnesota is open now, in 1 country. Recruiting first, the newest first:
University of Minnesota · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 70 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 2
First in 2005; this study’s year is marked. 2 started in 2017.
This study's enrollment of 309 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 77 across the 33 interventional studies, 0 across the 1 observational. Of the 29 that completed or were terminated, 7 (24%) have results posted.
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University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
1 of the studies in Motor Activity by University of Minnesota that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07649135University of MinnesotaFeasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke | 2026-11-30 |
Among the 34 studies in Motor Activity by University of Minnesota, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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 · Device: Physical activity monitors (e.g., Fitbit) · Other: Information about Health and Wellness
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 · Device: Physical activity monitors (e.g., Fitbit) · Behavioral: Interpersonal 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.
Behavioral: Otago Exercise Program · Device: Physical activity monitors (e.g., Fitbit) · Behavioral: 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
Behavioral: Otago Exercise Program · Device: Physical activity monitors (e.g., Fitbit) · Behavioral: Interpersonal Behavior Change Strategies · Behavioral: Intrapersonal Behavior Change Strategies
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.
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.
Also known as: PAM
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.
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
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.
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)
Time frame: 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.
Time frame: Baseline and Post-Intervention (one week, six months, twelve months)
Fall Rate
Falls per person year, assessed via prospective monthly calendars
Time frame: 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.
Time frame: 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.
Time frame: Baseline and post-intervention: one-week, six months, and 12 months
| Milestone | Otago+PAM+Health / Wellness Topics | Otago + PAM + Interpersonal Strategies | Otago, PAM, Intrapersonal Strategies | Otago,PAM, Inter+Intra Strategies |
|---|---|---|---|---|
| Started | 78 | 78 | 76 | 77 |
| Completed | 77 | 76 | 74 | 75 |
| Not completed | 1 | 2 | 2 | 2 |
Average weekly minutes of total physical activity per week (light, moderate and vigorous intensities) as captured from PAM data (Fitbit Charge-2)
| minutes per day | Otago+PAM+Health / Wellness Topics | Otago + PAM + Interpersonal Strategies | Otago, PAM, Intrapersonal Strategies | Otago,PAM, Inter+Intra Strategies |
|---|---|---|---|---|
| Baseline | 177.9 ± 62.2 | 167.7 ± 79.1 | 185.9 ± 70.5 | 177.9 ± 72.7 |
| one week post-intervention | 180.5 ± 68.5 | 193.1 ± 82.1 | 181 ± 68.2 | 209.1 ± 79.2 |
| six months post-intervention | 180 ± 73.8 | 185.7 ± 84 | 175.1 ± 68.9 | 198 ± 78 |
| twelve months post-intervention | 174.3 ± 72.0 | 190.3 ± 99.1 | 167.7 ± 68.6 | 192.9 ± 80.4 |
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.
| Total PASE Score | Otago+PAM+Health / Wellness Topics | Otago + PAM + Interpersonal Strategies | Otago, PAM, Intrapersonal Strategies | Otago,PAM, Inter+Intra Strategies |
|---|---|---|---|---|
| Baseline | 102.2 ± 46.4 | 108.3 ± 66.6 | 110.6 ± 44 | 101.8 ± 48.5 |
| One week post-intervention | 111.1 ± 47.3 | 119.2 ± 69.9 | 120.7 ± 56.2 | 121.1 ± 58.7 |
| Six months post-intervention | 106.7 ± 53.0 | 118.2 ± 65.1 | 119.5 ± 65.8 | 112.2 ± 60.1 |
| Twelve months post-intervention | 107.1 ± 60.0 | 113.8 ± 66.8 | 123.0 ± 92.3 | 112.4 ± 60.9 |
Falls per person year, assessed via prospective monthly calendars
| Falls per person year | Otago+PAM+Health / Wellness Topics | Otago + PAM + Interpersonal Strategies | Otago, PAM, Intrapersonal Strategies | Otago,PAM, Inter+Intra Strategies |
|---|---|---|---|---|
| Fall Rate | 0.9 | 1.0 | 0.9 | 1.1 |
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.
| Participants | Otago+PAM+Health / Wellness Topics | Otago + PAM + Interpersonal Strategies | Otago, PAM, Intrapersonal Strategies | Otago,PAM, Inter+Intra Strategies |
|---|---|---|---|---|
| Number of moderate injurious falls | 6 | 7 | 6 | 6 |
| Number of major injurious falls | 1 | 2 | 2 | 1 |
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.
| T score | Otago+PAM+Health / Wellness Topics | Otago + PAM + Interpersonal Strategies | Otago, PAM, Intrapersonal Strategies | Otago,PAM, Inter+Intra Strategies |
|---|---|---|---|---|
| Physical Health: Baseline | 39.2 ± 4.9 | 39.5 ± 5.3 | 39.1 ± 4.9 | 40 ± 5.1 |
| Physical Health: Post-intervention, One week | 40.2 ± 4.7 | 39.6 ± 5.5 | 39.6 ± 4.6 | 40.5 ± 5.0 |
| Physical Health: Post-intervention, six months | 38.7 ± 5.2 | 38.7 ± 5.6 | 39.2 ± 4.5 | 40.0 ± 5.1 |
| Physical Health 12 months post-intervention | 39.5 ± 5.3 | 39.1 ± 6.2 | 38.9 ± 5.1 | 39.3 ± 5.1 |
| Mental Health: Baseline | 50.8 ± 7.4 | 52.3 ± 7.9 | 51.8 ± 8.0 | 52.9 ± 8.1 |
| Mental Health: Post-intervention, One week | 53.1 ± 7.1 | 52.4 ± 7.9 | 52.2 ± 8.3 | 53.8 ± 8.0 |
| Mental Health: Post-intervention, Six months | 51.4 ± 7.0 | 50.6 ± 8.2 | 51.7 ± 7.4 | 52.8 ± 8.4 |
| Mental Health: Post-intervention, Twelve months | 51.1 ± 7.4 | 50.3 ± 8.3 | 50.3 ± 7.4 | 49.9 ± 8.3 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Otago+PAM+Health / Wellness Topics | 1/77 (1.3%) | 0/77 (0%) | 2/77 (2.6%) |
| Otago + PAM + Interpersonal Strategies | 2/76 (2.6%) | 0/76 (0%) | 7/76 (9.2%) |
| Otago, PAM, Intrapersonal Strategies | 1/74 (1.4%) | 0/74 (0%) | 3/74 (4.1%) |
| Otago,PAM, Inter+Intra Strategies | 0/75 (0%) | 2/75 (2.7%) | 3/75 (4%) |
| Event | Otago+PAM+Health / Wellness Topics | Otago + PAM + Interpersonal Strategies | Otago, PAM, Intrapersonal Strategies | Otago,PAM, Inter+Intra Strategies |
|---|---|---|---|---|
| cancerGeneral disorders | 0/77 | 0/76 | 0/74 | 1/75 |
| StrokeCardiac disorders | 0/77 | 0/76 | 0/74 | 1/75 |
| Event | Otago+PAM+Health / Wellness Topics | Otago + PAM + Interpersonal Strategies | Otago, PAM, Intrapersonal Strategies | Otago,PAM, Inter+Intra Strategies |
|---|---|---|---|---|
| fractureGeneral disorders | 0/77 | 2/76 | 1/74 | 0/75 |
| PainGeneral disorders | 2/77 | 1/76 | 1/74 | 1/75 |
| InfectionInfections and infestations | 0/77 | 1/76 | 1/74 | 0/75 |
| cancerGeneral disorders | 0/77 | 0/76 | 0/74 | 1/75 |
| lung illnessGeneral disorders | 0/77 | 0/76 | 0/74 | 1/75 |
| FallGeneral disorders | 0/77 | 1/76 | 0/74 | 0/75 |
| Polymyalgia rheumatica--unrelatedGeneral disorders | 0/77 | 1/76 | 0/74 | 0/75 |
| hyponatremiaGeneral disorders | 0/77 | 1/76 | 0/74 | 0/75 |
| Age, Continuous(years) | Otago+PAM+Health / Wellness Topics | Otago + PAM + Interpersonal Strategies | Otago, PAM, Intrapersonal Strategies | Otago,PAM, Inter+Intra Strategies | Total |
|---|---|---|---|---|---|
| Mean | 77.8 ± 5 | 77.7 ± 5 | 77.3 ± 5 | 76.6 ± 5.1 | 77.4 ± 5 |
| Sex: Female, Male(Participants) | Otago+PAM+Health / Wellness Topics | Otago + PAM + Interpersonal Strategies | Otago, PAM, Intrapersonal Strategies | Otago,PAM, Inter+Intra Strategies | Total |
|---|---|---|---|---|---|
| Female | 64 | 59 | 59 | 58 | 240 |
| Male | 14 | 19 | 17 | 19 | 69 |
| Race (NIH/OMB)(Participants) | Otago+PAM+Health / Wellness Topics | Otago + PAM + Interpersonal Strategies | Otago, PAM, Intrapersonal Strategies | Otago,PAM, Inter+Intra Strategies | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 0 | 1 |
| Asian | 0 | 1 | 1 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 13 | 10 | 16 | 9 | 48 |
| White | 65 | 66 | 57 | 67 | 255 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 | 0 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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
Supporting information: Study protocol, Informed consent form
Time frame: November 17, 2017 to September 2, 2022
Access criteria: IRB approval
Ran from Nov 2017 to primary completion in Oct 2023, 71 months.
Results were first posted in Apr 2024, 5 months after primary completion.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 71 months is above that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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