ExerciseNCT03326141
Community-based Intervention Effects on Older Adults' Physical Activity
A study testing Otago Exercise Program, Physical activity monitors (e.g., Fitbit) and Interpersonal Behavior Change Strategies in people with Exercise and Physical Activity, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exercise, Physical Activity, Accidental Fall
- What is being tested?
- Otago Exercise Program, Physical activity monitors (e.g., Fitbit) and Interpersonal Behavior Change Strategies
- Type of treatment
- Vaccines, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥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
Show all 11Show fewer
- 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
Who cannot join
- Lower extremity injury or surgery within the past 6 weeks
- Inability to walk
- Formal diagnosis of neurocognitive impairment or dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota - School of Nursing
Minneapolis, Minnesota, 55408
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise, Physical Activity, Accidental Fall, Motivation, Older Adults
- Being tested
- Otago Exercise Program, Physical activity monitors (e.g., Fitbit), Interpersonal Behavior Change Strategies, Intrapersonal Behavior Change Strategies, Information about Health and Wellness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise ProgramBehavioural
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.
Physical activity monitors (e.g., Fitbit)Device
Also called PAM
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.
Interpersonal Behavior Change StrategiesBehavioural
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.
Intrapersonal Behavior Change StrategiesBehavioural
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 WellnessOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Otago Exercise Program; Device: Physical activity monitors (e.g., Fitbit); Other: Information about Health and Wellness |
| 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. Receives: Behavioral: Otago Exercise Program; Device: Physical activity monitors (e.g., Fitbit); Behavioral: Interpersonal Behavior Change Strategies |
| 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. Receives: Behavioral: Otago Exercise Program; Device: Physical activity monitors (e.g., Fitbit); Behavioral: Intrapersonal Behavior Change Strategies |
| Otago,PAM, Inter+Intra strategies | Experimental | 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 Receives: Behavioral: Otago Exercise Program; Device: Physical activity monitors (e.g., Fitbit); Behavioral: Interpersonal Behavior Change Strategies; Behavioral: Intrapersonal Behavior Change Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Baseline and Post-Intervention (one week, six months, twelve months)
Secondary outcomes (3)
Fall Rate
Falls per person year, assessed via prospective monthly calendars
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention: one-week, six months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start17 Nov 2017
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Siobhan K McMahon, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326141
- Sponsor's protocol ID
- 1607S90922
- Other IDs
- 1R01NR016705-01A1
- Status last verified
- Mar 2024
- First submitted
- 1 Sep 2017
- Last updated
- 24 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
Publications
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.
PubMed 38421648
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Intervention Effects on Older Adults' Physical Activity and Falls (R01)
- ClinicalTrials.gov ID
- NCT03326141
- Acronym / sponsor ID
- 1607S90922
- Conditions
- Exercise, Physical Activity, Accidental Fall, Motivation, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Posted 24 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Otago+PAM+Health / Wellness topics | Active comparator | Behavioral: Otago Exercise Program, Device: Physical activity monitors (e.g., Fitbit), Other: Information about Health and WellnessCondition 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 | Experimental | Behavioral: Otago Exercise Program, Device: Physical activity monitors (e.g., Fitbit), Behavioral: Interpersonal Behavior Change StrategiesCondition 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 | Experimental | Behavioral: Otago Exercise Program, Device: Physical activity monitors (e.g., Fitbit), Behavioral: Intrapersonal Behavior Change StrategiesCondition 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 | Experimental | Behavioral: Otago Exercise Program, Device: Physical activity monitors (e.g., Fitbit), Behavioral: Interpersonal Behavior Change Strategies, Behavioral: Intrapersonal Behavior Change StrategiesCondition 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- ≥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)
Key exclusion criteria (3 listed)
- Lower extremity injury or surgery within the past 6 weeks
- Inability to walk
- Formal diagnosis of neurocognitive impairment or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Otago Exercise ProgramThe 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. | Behavioural | Otago + PAM + Interpersonal strategies, Otago+PAM+Health / Wellness topics, Otago, PAM, Intrapersonal strategies, Otago,PAM, Inter+Intra strategies |
| Physical activity monitors (e.g., Fitbit)Also: PAMWe 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. | Device | Otago + PAM + Interpersonal strategies, Otago+PAM+Health / Wellness topics, Otago, PAM, Intrapersonal strategies, Otago,PAM, Inter+Intra strategies |
| Interpersonal Behavior Change StrategiesThe 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. | Behavioural | Otago + PAM + Interpersonal strategies, Otago,PAM, Inter+Intra strategies |
| Intrapersonal Behavior Change StrategiesThe 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 | Behavioural | Otago, PAM, Intrapersonal strategies, Otago,PAM, Inter+Intra strategies |
| Information about Health and WellnessInformation 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. | Other | Otago+PAM+Health / Wellness topics |
Primary outcome
Quantity of Physical Activity Measured Objectively
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Fall Rate
Time frame: 12 months post intervention
Number of Participants With Moderate or Major Injuries From Falls
Time frame: 12 months post intervention
Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health
Time frame: Baseline and post-intervention: one-week, six months, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38421648McMahon 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.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siobhan K McMahon, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago Exercise Program, Physical activity monitors (e.g., Fitbit) and Interpersonal Behavior Change Strategies in people with Exercise and Physical Activity, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of Physical Activity Measured Objectively (time frame: Baseline and Post-Intervention (one week, six months, twelve months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03326141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.