Accidental FallsPhase 2ReadySteadyNCT02433249
Developing a Intervention to Enhance Motivation for Physical Activities Known to Reduce Fall Risk
A Phase 2 study testing 1 Physical Activity, Interpersonal Motivation and Intrapersonal Motivation in people with Accidental Falls and Sedentary Lifestyle, run by University of Minnesota.
Trial summary
The purpose of this pilot study is to develop an intervention, based on empirical evidence and health-related behavioral change theory, to enhance motivation for engaging in fall-reducing physical activities. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Sedentary Lifestyle
- What is being tested?
- 1 Physical Activity, Interpersonal Motivation and Intrapersonal Motivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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, level of physical activity (strength training and aerobic) below national recommendations
Who cannot join
- Dementia, recent injury or surgery, unable to participate in light-moderately intense exercise
About this study
Official title: Enhancing Motivation for Physical Activity to Reduce the Risk of Falls Among Community-Dwelling Older Adults: A Wellness Intervention.
The purpose of this pilot study is to develop an intervention, based on empirical evidence and health-related behavioral change theory, to enhance motivation for engaging in fall-reducing physical activities.
Read the detailed description
The intervention being developed, Ready~Steady, combines 3 components; a) interpersonal motivation, b) intrapersonal motivation, and c) physical activity. Theoretical concepts from the wellness motivation theory are (a) translated into intervention strategies; and (b) operationalized as variables to form a basis for evaluating this intervention. The overall objective is to advance the development of Ready~Steady by assessing the impact of its motivation components.
- Conditions
- Accidental Falls, Sedentary Lifestyle
- Being tested
- 1 Physical Activity, Interpersonal Motivation, Intrapersonal Motivation
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Physical ActivityBehavioural
Also called Otago
Fall reducing strength (5), balance (12) and flexibility (4) exercises as well as walking. Participants were also given a Fitbit One with instructions on how to use
Interpersonal MotivationBehavioural
Strategies used to support Interpersonal motivational targets include: a) discuss and model ways to provide and receive more support for physical activity, b) identify environmental barriers to being physically active, c) problem-solve environmental and social barriers to being physically active, d) use and create new resources that support physical activity behavior
Intrapersonal MotivationBehavioural
Strategies used to support intrapersonal motivation included a) use of the goal attainment scale, b) facilitating the formation of action plans, c) identify and problem solve personal barriers to being active, d) identify satisfying aspects of being active, e) self-evaluate physical activity patterns and progress.
| Study group | Role | What they receive |
|---|---|---|
| 1 Physical Activity | Active comparator | Small groups (4-7 people) meeting in community centers weekly for 90 minutes, over the course of 8 weeks. Curricula for meetings are manualized and include introducing and practicing Otago exercises, progressed according to individual capacity and preference, as well as falls prevention. All participant receive Fitbit Ones and are asked to use them on a daily basis. Receives: Behavioral: 1 Physical Activity |
| 2 Interpersonal Motivation | Experimental | Small groups (4-7 people) meeting in community centers weekly for 90 minutes, over the course of 8 weeks. Curricula for meetings are manualized and include introducing and practicing Otago exercises, progressed according to individual capacity and preference, as well as falls prevention. The interventionist also facilitates discussions addressing the interpersonal motivational intervention content. All participant receive Fitbit Ones and are asked to use them on a daily basis: Fitbit Ones are included in weekly discussions. Receives: Behavioral: 1 Physical Activity; Behavioral: Interpersonal Motivation |
| 3.Intrapersonal Motivation | Experimental | Small groups (4-7 people) meeting in community centers weekly for 90 minutes, over the course of 8 weeks. Curricula for meetings are manualized and include introducing and practicing Otago exercises, progressed according to individual capacity and preference, as well as falls prevention. The interventionist also facilitates discussions addressing the intrapersonal motivational intervention content. All participant receive Fitbit Ones and are asked to use them on a daily basis: Fitbit Ones are included in weekly discussions. Receives: Behavioral: 1 Physical Activity; Behavioral: Intrapersonal Motivation |
| 4.Full Intervention | Experimental | Small groups (4-7 people) meeting in community centers weekly for 90 minutes, over the course of 8 weeks. Curricula for meetings are manualized and include introducing and practicing Otago exercises, progressed according to individual capacity and preference, as well as falls prevention. The interventionist also facilitates discussions addressing the intrapersonal and interpersonal motivational intervention content. All participant receive Fitbit Ones and are asked to use them on a daily basis: Fitbit Ones are included in weekly discussions. Receives: Behavioral: 1 Physical Activity; Behavioral: Interpersonal Motivation; Behavioral: Intrapersonal Motivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported physical activity behavior
Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
Measured: Baseline; 1 week post; 6 months post
Change in objectively measured physical activity behavior
Accelerometers built in to Fitbit Ones
Measured: Baseline; 1 week post; 6 months post
Secondary outcomes (8)
Change in functional strength and balance
Short Physical Performance Battery
Measured: Baseline; 1 week post; 6 months post
Change in functional strength and balance
Timed Up and Go
Measured: Baseline; 1 week post; 6 months post
Change in the number of community resources used for physical activity
Number of community resources identified and used: 2 item survey
Measured: Baseline; 1 week post; 6 months post
Change in social support for fall-reducing physical activities
Social support for exercise: Survey
Measured: Baseline; 1 week post; 6 months post
Change in readiness
Index of Readiness
Measured: Baseline; 1 week post; 6 months post
Change in self-regulation
Index of Self-Regulation
Measured: Baseline; 1 week post; 6 months post
Change in self-reported lower extremity function
Neuro-QOL SF v1.0 - LEx Fnct (Mobility)
Measured: Baseline; 1 week post; 6 months post
Change in self-reported ability to participate in social activities
PROMIS SF v2.0 - Ability to Participate Social 4a
Measured: Baseline; 1 week post; 6 months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siobhan K McMahon, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433249
- Sponsor's protocol ID
- 1402S47802
- Acronym
- ReadySteady
- Status last verified
- Oct 2019
- First submitted
- 19 Feb 2015
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
McMahon S, Vankipuram M, Hekler EB, Fleury J. Design and evaluation of theory-informed technology to augment a wellness motivation intervention. Transl Behav Med. 2014 Mar;4(1):95-107. doi: 10.1007/s13142-013-0221-4.
PubMed 24653780McMahon S, Fleury J. Wellness in older adults: a concept analysis. Nurs Forum. 2012 Jan-Mar;47(1):39-51. doi: 10.1111/j.1744-6198.2011.00254.x.
PubMed 22309381Perez A, Fleury J. Wellness motivation theory in practice. Geriatr Nurs. 2009 Mar-Apr;30(2 Suppl):15-20. doi: 10.1016/j.gerinurse.2009.02.006. No abstract available.
PubMed 19345859McMahon S, Talley KM, Wyman JF. Older people's perspectives on fall risk and fall prevention programs: a literature review. Int J Older People Nurs. 2011 Dec;6(4):289-98. doi: 10.1111/j.1748-3743.2011.00299.x.
PubMed 22078019McMahon SK, Lewis B, Oakes JM, Wyman JF, Guan W, Rothman AJ. Examining Potential Psychosocial Mediators in a Physical Activity Intervention for Older Adults. West J Nurs Res. 2020 Aug;42(8):581-592. doi: 10.1177/0193945919871697. Epub 2019 Aug 30.
PubMed 31470769McMahon SK, Lewis B, Oakes JM, Wyman JF, Guan W, Rothman AJ. Assessing the Effects of Interpersonal and Intrapersonal Behavior Change Strategies on Physical Activity in Older Adults: a Factorial Experiment. Ann Behav Med. 2017 Jun;51(3):376-390. doi: 10.1007/s12160-016-9863-z.
PubMed 28188585McMahon SK, Lewis B, Oakes M, Guan W, Wyman JF, Rothman AJ. Older Adults' Experiences Using a Commercially Available Monitor to Self-Track Their Physical Activity. JMIR Mhealth Uhealth. 2016 Apr 13;4(2):e35. doi: 10.2196/mhealth.5120.
PubMed 27076486
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Motivation for Physical Activity to Reduce the Risk of Falls Among Community-Dwelling Older Adults: A Wellness Intervention.
- ClinicalTrials.gov ID
- NCT02433249
- Acronym / sponsor ID
- ReadySteady / 1402S47802
- Conditions
- Accidental Falls, Sedentary Lifestyle
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to develop an intervention, based on empirical evidence and health-related behavioral change theory, to enhance motivation for engaging in fall-reducing physical activities.
Detailed description
The intervention being developed, Ready~Steady, combines 3 components; a) interpersonal motivation, b) intrapersonal motivation, and c) physical activity. Theoretical concepts from the wellness motivation theory are (a) translated into intervention strategies; and (b) operationalized as variables to form a basis for evaluating this intervention. The overall objective is to advance the development of Ready~Steady by assessing the impact of its motivation components.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 Physical Activity | Active comparator | Behavioral: 1 Physical ActivitySmall groups (4-7 people) meeting in community centers weekly for 90 minutes, over the course of 8 weeks. Curricula for meetings are manualized and include introducing and practicing Otago exercises, progressed according to individual capacity and preference, as well as falls prevention. All participant receive Fitbit Ones and are asked to use them on a daily basis. |
| 2 Interpersonal Motivation | Experimental | Behavioral: 1 Physical Activity, Behavioral: Interpersonal MotivationSmall groups (4-7 people) meeting in community centers weekly for 90 minutes, over the course of 8 weeks. Curricula for meetings are manualized and include introducing and practicing Otago exercises, progressed according to individual capacity and preference, as well as falls prevention. The interventionist also facilitates discussions addressing the interpersonal motivational intervention content. All participant receive Fitbit Ones and are asked to use them on a daily basis: Fitbit Ones are included in weekly discussions. |
| 3.Intrapersonal Motivation | Experimental | Behavioral: 1 Physical Activity, Behavioral: Intrapersonal MotivationSmall groups (4-7 people) meeting in community centers weekly for 90 minutes, over the course of 8 weeks. Curricula for meetings are manualized and include introducing and practicing Otago exercises, progressed according to individual capacity and preference, as well as falls prevention. The interventionist also facilitates discussions addressing the intrapersonal motivational intervention content. All participant receive Fitbit Ones and are asked to use them on a daily basis: Fitbit Ones are included in weekly discussions. |
| 4.Full Intervention | Experimental | Behavioral: 1 Physical Activity, Behavioral: Interpersonal Motivation, Behavioral: Intrapersonal MotivationSmall groups (4-7 people) meeting in community centers weekly for 90 minutes, over the course of 8 weeks. Curricula for meetings are manualized and include introducing and practicing Otago exercises, progressed according to individual capacity and preference, as well as falls prevention. The interventionist also facilitates discussions addressing the intrapersonal and interpersonal motivational intervention content. All participant receive Fitbit Ones and are asked to use them on a daily basis: Fitbit Ones are included in weekly discussions. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- ≥ 70 years, level of physical activity (strength training and aerobic) below national recommendations
Key exclusion criteria (1 listed)
- Dementia, recent injury or surgery, unable to participate in light-moderately intense exercise
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 |
|---|---|---|
| 1 Physical ActivityAlso: OtagoFall reducing strength (5), balance (12) and flexibility (4) exercises as well as walking. Participants were also given a Fitbit One with instructions on how to use | Behavioural | 1 Physical Activity, 2 Interpersonal Motivation, 3.Intrapersonal Motivation, 4.Full Intervention |
| Interpersonal MotivationStrategies used to support Interpersonal motivational targets include: a) discuss and model ways to provide and receive more support for physical activity, b) identify environmental barriers to being physically active, c) problem-solve environmental and social barriers to being physically active, d) use and create new resources that support physical activity behavior | Behavioural | 2 Interpersonal Motivation, 4.Full Intervention |
| Intrapersonal MotivationStrategies used to support intrapersonal motivation included a) use of the goal attainment scale, b) facilitating the formation of action plans, c) identify and problem solve personal barriers to being active, d) identify satisfying aspects of being active, e) self-evaluate physical activity patterns and progress. | Behavioural | 3.Intrapersonal Motivation, 4.Full Intervention |
Primary outcome
Change in self-reported physical activity behavior
Time frame: Baseline; 1 week post; 6 months post
Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
Change in objectively measured physical activity behavior
Time frame: Baseline; 1 week post; 6 months post
Accelerometers built in to Fitbit Ones
8 secondary outcomes
Change in functional strength and balance
Time frame: Baseline; 1 week post; 6 months post
Change in functional strength and balance
Time frame: Baseline; 1 week post; 6 months post
Change in the number of community resources used for physical activity
Time frame: Baseline; 1 week post; 6 months post
Change in social support for fall-reducing physical activities
Time frame: Baseline; 1 week post; 6 months post
Change in readiness
Time frame: Baseline; 1 week post; 6 months post
Change in self-regulation
Time frame: Baseline; 1 week post; 6 months post
Change in self-reported lower extremity function
Time frame: Baseline; 1 week post; 6 months post
Change in self-reported ability to participate in social activities
Time frame: Baseline; 1 week post; 6 months post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Background: PubMed 24653780McMahon S, Vankipuram M, Hekler EB, Fleury J. Design and evaluation of theory-informed technology to augment a wellness motivation intervention. Transl Behav Med. 2014 Mar;4(1):95-107. doi: 10.1007/s13142-013-0221-4.
- Background: PubMed 22309381McMahon S, Fleury J. Wellness in older adults: a concept analysis. Nurs Forum. 2012 Jan-Mar;47(1):39-51. doi: 10.1111/j.1744-6198.2011.00254.x.
- Background: PubMed 19345859Perez A, Fleury J. Wellness motivation theory in practice. Geriatr Nurs. 2009 Mar-Apr;30(2 Suppl):15-20. doi: 10.1016/j.gerinurse.2009.02.006. No abstract available.
- Background: PubMed 22078019McMahon S, Talley KM, Wyman JF. Older people's perspectives on fall risk and fall prevention programs: a literature review. Int J Older People Nurs. 2011 Dec;6(4):289-98. doi: 10.1111/j.1748-3743.2011.00299.x.
- Derived from this study: PubMed 31470769McMahon SK, Lewis B, Oakes JM, Wyman JF, Guan W, Rothman AJ. Examining Potential Psychosocial Mediators in a Physical Activity Intervention for Older Adults. West J Nurs Res. 2020 Aug;42(8):581-592. doi: 10.1177/0193945919871697. Epub 2019 Aug 30.
- Derived from this study: PubMed 28188585McMahon SK, Lewis B, Oakes JM, Wyman JF, Guan W, Rothman AJ. Assessing the Effects of Interpersonal and Intrapersonal Behavior Change Strategies on Physical Activity in Older Adults: a Factorial Experiment. Ann Behav Med. 2017 Jun;51(3):376-390. doi: 10.1007/s12160-016-9863-z.
- Derived from this study: PubMed 27076486McMahon SK, Lewis B, Oakes M, Guan W, Wyman JF, Rothman AJ. Older Adults' Experiences Using a Commercially Available Monitor to Self-Track Their Physical Activity. JMIR Mhealth Uhealth. 2016 Apr 13;4(2):e35. doi: 10.2196/mhealth.5120.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1 Physical Activity, Interpersonal Motivation and Intrapersonal Motivation in people with Accidental Falls and Sedentary Lifestyle, run by University of Minnesota.
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 1 inclusion and 1 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in self-reported physical activity behavior (time frame: Baseline; 1 week post; 6 months post). 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 NCT02433249, which also lists 7 linked publications.
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 1 Nov 2019.