ExercisePhase 1/2NCT05693025
Evaluation of the Walk With Ease Program for Fall Prevention
A Phase 1/2 study testing Group Exercise and Behavioral Training in people with Exercise and Frailty, run by Iowa State University at 1 site in United States.
Trial summary
The study will use a randomized controlled trial design to evaluate the potential of incorporating physical therapy exercises (primary prevention strategy) within an evidence-based intervention called Walk with Ease to reduce falls and fall risk in older, community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Group Exercise and Behavioral Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2023to 15 May 2026
- Phase
- Phase 1/2
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- being able to stand for at least 10 minutes without pain
- written permission from a physician
Who cannot join
- Already somewhat active (defined as at least 15 minutes of physical activity per day)
- Not at risk for falls (based on STEADI criteria)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Department of Kinesiology
Ames, Iowa, 50011
Principal Investigator, Ph.D., 515-450-7585, gwelk@iastate.edu
Clinical Research Coordinator, Ph.D., 5156814722, jenil@iastate.edu
About this study
Official title: Process and Outcome Evaluation of the Walk With Ease Program for Fall Prevention
The study will use a randomized controlled trial design to evaluate the potential of incorporating physical therapy exercises (primary prevention strategy) within an evidence-based intervention called Walk with Ease to reduce falls and fall risk in older, community-dwelling older adults. The integrated process and outcome evaluation will determine the relative effectiveness of individually prescribed exercises (compared to standardized exercises) as well as the potential of 'habit training' resources to improve compliance with exercises in this population. The study, conducted through a local clinical / community partnership will advance both science and practice while also informing implementation strategies needed to promote broader dissemination.
Read the detailed description
The study will evaluate the effectiveness of incorporating physical therapy exercises (primary prevention strategy) within an established physical activity intervention called Walk with Ease (WWE) to reduce incidence and risk of falls in community-dwelling older adults. A randomized controlled design will be used to systematically test the Standard Implementation (SI) model with generic exercise recommendations against an Enhanced Implementation (EI) model that provides individually-prescribed, physical therapy exercises. Standard Education (SE) resources will also be directly compared against an Enhanced Education (EE) resources based on theory-based, habit formation approaches using a 2 x 2 factorial approach.
The primary hypothesis is that the participants in the EI condition will have lower incidence of falls and larger reductions in fall risk than those in the SI condition. The secondary hypothesis is that participants receiving the EE resources will have greater compliance to the prescribed exercise, higher levels of physical activity, and better fall risk reduction outcomes than those receiving SE resources. The study will include a robust process evaluation (Aim 1) and outcome evaluation (Aim 2), along with a supplemental feasibility study (Aim 3) to identify actionable factors within the implementation context that could positively influence the scalability of WWE to reach rural populations.
The primary outcome based on the frequency of falls will be analyzed with a negative binomial regression model. The primary interest is in the β coefficient that quantifies the program main effect, averaged over behavioral treatments. If dropout is informative, we will impute the missing observations using a mixed model to account for variability between individuals. The primary hypothesis will also be evaluated using a continuous fall risk score developed by Helsel et al. based on longitudinal fall risk data. Assuming normally distributed data, our primary hypothesis will be a contrast evaluating the average change between baseline and 6 weeks in the two enhanced program treatments.
We will recruit 240 participants into the overall trial and project a final sample of 180 completers, based on a 25% dropout rate, providing a final sample size is 45 individuals in each of the four treatment groups. Based on outcomes from a related clinical trial by Li et al.70 we would have 80% power to detect a 14% reduction in fall frequency between conditions and 95% power to detect a 18% reduction in fall frequency between conditions. Using the continuous risk score proposed by Helsel et al. we would have 80% power to detect a 0.7 unit change in Helsel score or an 11% increase in the odds of a fall in one year. We would have 95% power to detect a 0.8 unit change in Helsel score or an 13% increase in the odds of a fall in one year.
- Conditions
- Exercise, Frailty, Arthritis, Accidental Falls
- Being tested
- Group Exercise, Behavioral Training
- Keywords
- physical activity, fear of falling, balance, Walking, Older Adults
- Medical subject headings
- Motor Activity, Frailty, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ExerciseBehavioural
The study evaluates two different approaches for group exercise. Participants in the Standard Implementation (SI) group complete the standard Walk with Ease intervention as recommended by the Arthritis Foundation. Participants are guided to learn and perform a series of stretching and strengthening exercises recommended in the base WWE program. Primary BCTs include instruction on how to perform behavior (#4.1) and Graded tasks (#8.7). Participants in the Enhanced Implementation (SI) group complete the standard Walk with Ease intervention as recommended by the Arthritis Foundation. They may perform some of the same exercises as those in the SI group but they are also guided to learn and perform specific exercises prescribed by a physical therapist to improve balance and reduce risks of falling. The primary BCTs include instruction on how to perform behavior (#4.1), Graded tasks (#8.7) from the base program as well as Information on health consequences (#5.1) and Credible source (#9.1).
Behavioral TrainingBehavioural
The study evaluates two different approaches for promoting behavior change. Participants in the Standard Training (ST) model follow the standardized Walk with Ease training to support behavior change. Participants are provided with goal setting tools and an online tracker to monitor their progress. Weekly video-based lessons, resource links and eBook content support behavior change. Primary BCTs include Goal Setting (BCT #1.1) and self-monitoring (BCT#2.3). Participants in the Enhanced Training (ET) model access the same basic content as the ST model, but the weekly education-based videos are replaced with lessons focus on habit-formation training. Student coaches are also assigned to individual participants to support behavior change efforts using motivational interviewing strategies. Thus, participants in the ET model also receive two additional theory- and evidence-based BCTs: (1) habit formation training (BCT#1.2, #1.4, #8.3) and (2 health coaching (BCT# 3.3).
| Study group | Role | What they receive |
|---|---|---|
| Standard Implementation (SI) | Active comparator | Participants the Standard Implementation (SI) model complete a 6 week structured Walk with Ease group exercise program designed to build capacity and function in older adults. Sessions are held 3 days a week for an hour each session. Each session includes a 10 minute warmup including strength/flexibility exercises, a 30 minute bout of walking and a 10 minute cool-down including strength/flexibility exercises. Participants complete standard exercises recommended in the base program. Receives: Behavioral: Group Exercise |
| Enhanced Implementation (EI) | Experimental | Participants the Enhanced Implementation (SI) model complete the 6 week structured Walk with Ease group exercise program designed to build capacity and function in older adults. Sessions are held 3 days a week for an hour each session. Each session includes a 10 minute warmup including strength/flexibility exercises, a 30 minute bout of walking and a 10 minute cool-down including strength/flexibility exercises. Participants complete personalized exercises prescribed by a licensed Physical Therapist to help reduce potential risks of falling. Receives: Behavioral: Group Exercise |
| Standard Training (ST) | Active comparator | Participants the Standard Training (ST) model receive access to on online portal with weekly tips and education content, goal setting options and a daily tracking system for logging walking and exercises performed. They receive instruction on how to use the portal and are encouraged to use the integrated eBook and resources to supplement the group exercise programming. Weekly video-based lessons provide standard knowledge-based training about how to become more physically active. Receives: Behavioral: Behavioral Training |
| Enhanced Training (ET) | Experimental | Participants the Enhanced Training (ET) model receive access to on online portal with weekly tips and education content, goal setting options and a daily tracking system for logging walking and exercises performed. They receive instruction on how to use the portal and are encouraged to use the integrated eBook and resources to supplement the group exercise programming. Weekly video-based lessons provide habit-formation training about how to form regular habits for physical activity. Participants are paired with a student 'coach' trained in motivational interviewing skills to provide virtual assistance in maintaining motivation during the programming. Receives: Behavioral: Behavioral Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fall Risk
Reported falls will be tracked using surveys as well as from the electronic medical record data. Reductions in fall risk will be evaluated using indicators from the established STEADI protocol with continuous fall risk scores computed using a validated algorithm.
Measured: 0, 6 weeks, 6 months, 12 months
Change in Physical Activity Behavior
PA behavior will be captured using the International Physical Activity Questionnaire - Elderly (IPAQ-E) will be evaluated at all time points to estimate minutes of physical activity. While less robust than monitor-based methods, the IPAQ-E has been validated against criterion measures of physical activity and has demonstrated adequate sensitivity and specificity for evaluating physical activity among adults aged 65 years and older.
Measured: 0, 6 weeks, 6 months, 12 months
Secondary outcomes (9)
Change in Perceived Health
The PROMIS Global Health Questionnaire will be used to capture overall perceptions of health. The Global Health questionnaire includes 10 items with single items capturing perceptions of global health and well-being. Two sets of subscales (4 items each) capture mental health and physical health. All items are 5 point likert items that would be used individually (or as an average) with higher scores reflecting stronger perceptions or more favorable perceptions of health.
Measured: 0, 6 weeks, 6 months, 12 months.
Change in Fear of Falling
The PROMIS Fear of Falling Questionnaire will be used to capture changes in perceptions of fall risk. The instrument includes a single questions (1-5 scale) about fear of falling and additional items (relative degree of concern, likelihood of falling, likelihood of injury, preventability, and perceptions about the role of physical activity for fall prevention. The fear item will be evaluated independently with higher scores reflecting stronger fear of falling.
Measured: 0, 6 weeks, 6 months, 12 months.
Change in Physical Function
Selected items from the PROMIS Physical Function 20a [based on the Health Assessment Questionnaire (HAQ) survey] will be used to evaluate change in function. The tool asks participants to rate the difficulty in performing twenty common activities of daily living but only those related to physical activity behavior and function were included. The total score will be used to evaluate changes in physical function.
Measured: 0, 6 weeks, 6 months, 12 months.
Change in Falls Efficacy
The Falls Efficacy Scale International (FES-I) will be used to evaluate confidence in being able to perform activities of daily living.12 The measure includes a series of 16 common activities of daily living that may pose challenges for older adults with a fear of falling. Participants are asked to rate their level of concern towards performing each activity without falling on a scale of 1 to 4, with 4 indicating very high levels of concern. The FES-I has demonstrated sensitivity to detect between-group differences based on demographic and fall risk factor differences and is suitable for detecting changes in fear of falling among older adults. The FES-I will be scored by summing the response to each of the 16 presented activities to an overall total, with scores ≥23, of a possible 64 indicating high concern about falling.
Measured: 0, 6 weeks, 6 months, 12 months
Change in Capability (to exercise)
Capability is a key construct in the COM-B (Capability-Opportunity-Motivation and Behavior) framework. It will be assessed using two standard, single-item ratings of self-efficacy (one for walking and one for performing stretching and strengthening exercise). The 5 point Likert scales (Strongly Disagree to Strongly Agree) will be averaged with a higher score reflecting higher self-efficacy.
Measured: 0, 6 weeks, 6 months, 12 months.
Change in Opportunity (to exercise)
Opportunity is a key construct in the COM-B (Capability-Opportunity-Motivation and Behavior) framework. It will be captured as habit strength for exercise. Habit Formation will be assessed with the self-report behavioral automaticity scale, a 4-item scale that assesses the perceived automaticity with which someone engages in his/her goal activities related to walking (2 items) and stretching/strengthening exercise (2 items). The 7 point Likert scales (Not at All to Very Much) will be averaged with a higher score reflecting higher habit strength for the two separate behaviors.
Measured: 0, 6 weeks, 6 months, 12 months.
Change in Motivation (to exercise)
Motivation is a key construct in the COM-B (Capability-Opportunity-Motivation and Behavior) framework. It will be captured with a reduced set of 4 items from the established Behavioral Regulation of Exercise Questionnaire (BREQ version 3) which will capture intrinsic motivation related to walking (2 items) and stretching/strengthening exercise (2 items). One set of items evaluates enjoyment and the other set pleasure from the activity. The 5 point Likert scales (Not True for Me to Very True for Me) will be averaged for each of the behaviors. Higher scores reflect higher levels of intrinsic motivation.
Measured: 0, 6 weeks, 6 months, 12 months.
Change in Enjoyment (of exercise)
Enjoyment is an important predictor of behavior change and adherence to exercise. It will be captured using a short version of the established PACES tool (4 items) that capture enjoyment and pleasure as these are the main indicators of interest.
The 5 point Likert scales (Strongly Disagree to Strongly Agree) will be averaged for the overall score with higher scores reflecting greater enjoyment.
Measured: 0, 6 weeks, 6 months, 12 months
Change in Overall Strength
Grip Strength will provide an indicator of overall strength and function. It will be assessed with a research-grade hand dynamometer with assessments obtained on both right and left side
Measured: 0, 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start27 Feb 2023
- Primary completion15 May 2025 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The study will use a 2x2 factorial randomized controlled trial to evaluate the combinations of two types of exercise prescription and two types of behavioral training. The exercise prescription factor evaluates the relative effectiveness of two implementation strategies for the group WWE format (Standard vs Enhanced). The behavioral training factor compares Standard content to Enhanced content focused on building habit formation. This feature will enable the simultaneous evaluation of strategies to promote compliance with exercise prescriptions, a main limitation of current physical therapy-based approaches to fall prevention.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Welk, Iowa State University
- Investigators
- Candis M. Hunter, Ph.D., Study director, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693025
- Sponsor's protocol ID
- U01CE003490
- Status last verified
- Mar 2024
- First submitted
- 28 Dec 2022
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will include self-reported demographic data and individual behavioral data as well as clinical data from screening visits before and after intervention. All data will be stripped of identifiers so that the database will only retain coded ID numbers. We will make the data and associated documentation available to collaborating partners on the project including representatives from CHPcommunity, the Arthritis Foundation and the National Association of Chronic Disease Directors (NACDD) upon request. We will also make the data available to other users under data-sharing agreements that document a commitment to using the data only for research purposes.
Publications
Lamoureux NR, Lansing J, Dixon PM, Phillips LA, Radske-Suchan T, Dorneich MC, Chou LS, Welk GJ. Study protocol: process and outcome evaluation of the Walk with Ease program for fall prevention. BMC Public Health. 2024 Sep 28;24(1):2658. doi: 10.1186/s12889-024-20138-z.
PubMed 39342204
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process and Outcome Evaluation of the Walk With Ease Program for Fall Prevention
- ClinicalTrials.gov ID
- NCT05693025
- Acronym / sponsor ID
- U01CE003490
- Conditions
- Exercise, Frailty, Arthritis, Accidental Falls
- Keywords
- physical activity, fear of falling, balance, Walking, Older Adults
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 20 Jan 2023 (actual)
- 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 study will use a randomized controlled trial design to evaluate the potential of incorporating physical therapy exercises (primary prevention strategy) within an evidence-based intervention called Walk with Ease to reduce falls and fall risk in older, community-dwelling older adults. The integrated process and outcome evaluation will determine the relative effectiveness of individually prescribed exercises (compared to standardized exercises) as well as the potential of 'habit training' resources to improve compliance with exercises in this population. The study, conducted through a local clinical / community partnership will advance both science and practice while also informing implementation strategies needed to promote broader dissemination.
Detailed description
The study will evaluate the effectiveness of incorporating physical therapy exercises (primary prevention strategy) within an established physical activity intervention called Walk with Ease (WWE) to reduce incidence and risk of falls in community-dwelling older adults. A randomized controlled design will be used to systematically test the Standard Implementation (SI) model with generic exercise recommendations against an Enhanced Implementation (EI) model that provides individually-prescribed, physical therapy exercises. Standard Education (SE) resources will also be directly compared against an Enhanced Education (EE) resources based on theory-based, habit formation approaches using a 2 x 2 factorial approach.
The primary hypothesis is that the participants in the EI condition will have lower incidence of falls and larger reductions in fall risk than those in the SI condition. The secondary hypothesis is that participants receiving the EE resources will have greater compliance to the prescribed exercise, higher levels of physical activity, and better fall risk reduction outcomes than those receiving SE resources. The study will include a robust process evaluation (Aim 1) and outcome evaluation (Aim 2), along with a supplemental feasibility study (Aim 3) to identify actionable factors within the implementation context that could positively influence the scalability of WWE to reach rural populations.
The primary outcome based on the frequency of falls will be analyzed with a negative binomial regression model. The primary interest is in the β coefficient that quantifies the program main effect, averaged over behavioral treatments. If dropout is informative, we will impute the missing observations using a mixed model to account for variability between individuals. The primary hypothesis will also be evaluated using a continuous fall risk score developed by Helsel et al. based on longitudinal fall risk data. Assuming normally distributed data, our primary hypothesis will be a contrast evaluating the average change between baseline and 6 weeks in the two enhanced program treatments.
We will recruit 240 participants into the overall trial and project a final sample of 180 completers, based on a 25% dropout rate, providing a final sample size is 45 individuals in each of the four treatment groups. Based on outcomes from a related clinical trial by Li et al.70 we would have 80% power to detect a 14% reduction in fall frequency between conditions and 95% power to detect a 18% reduction in fall frequency between conditions. Using the continuous risk score proposed by Helsel et al. we would have 80% power to detect a 0.7 unit change in Helsel score or an 11% increase in the odds of a fall in one year. We would have 95% power to detect a 0.8 unit change in Helsel score or an 13% increase in the odds of a fall in one year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study will use a 2x2 factorial randomized controlled trial to evaluate the combinations of two types of exercise prescription and two types of behavioral training. The exercise prescription factor evaluates the relative effectiveness of two implementation strategies for the group WWE format (Standard vs Enhanced). The behavioral training factor compares Standard content to Enhanced content focused on building habit formation. This feature will enable the simultaneous evaluation of strategies to promote compliance with exercise prescriptions, a main limitation of current physical therapy-based approaches to fall prevention.
| Arm | Type | Receives |
|---|---|---|
| Standard Implementation (SI) | Active comparator | Behavioral: Group ExerciseParticipants the Standard Implementation (SI) model complete a 6 week structured Walk with Ease group exercise program designed to build capacity and function in older adults. Sessions are held 3 days a week for an hour each session. Each session includes a 10 minute warmup including strength/flexibility exercises, a 30 minute bout of walking and a 10 minute cool-down including strength/flexibility exercises. Participants complete standard exercises recommended in the base program. |
| Enhanced Implementation (EI) | Experimental | Behavioral: Group ExerciseParticipants the Enhanced Implementation (SI) model complete the 6 week structured Walk with Ease group exercise program designed to build capacity and function in older adults. Sessions are held 3 days a week for an hour each session. Each session includes a 10 minute warmup including strength/flexibility exercises, a 30 minute bout of walking and a 10 minute cool-down including strength/flexibility exercises. Participants complete personalized exercises prescribed by a licensed Physical Therapist to help reduce potential risks of falling. |
| Standard Training (ST) | Active comparator | Behavioral: Behavioral TrainingParticipants the Standard Training (ST) model receive access to on online portal with weekly tips and education content, goal setting options and a daily tracking system for logging walking and exercises performed. They receive instruction on how to use the portal and are encouraged to use the integrated eBook and resources to supplement the group exercise programming. Weekly video-based lessons provide standard knowledge-based training about how to become more physically active. |
| Enhanced Training (ET) | Experimental | Behavioral: Behavioral TrainingParticipants the Enhanced Training (ET) model receive access to on online portal with weekly tips and education content, goal setting options and a daily tracking system for logging walking and exercises performed. They receive instruction on how to use the portal and are encouraged to use the integrated eBook and resources to supplement the group exercise programming. Weekly video-based lessons provide habit-formation training about how to form regular habits for physical activity. Participants are paired with a student 'coach' trained in motivational interviewing skills to provide virtual assistance in maintaining motivation during the programming. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- being able to stand for at least 10 minutes without pain
- written permission from a physician
Key exclusion criteria (2 listed)
- Already somewhat active (defined as at least 15 minutes of physical activity per day)
- Not at risk for falls (based on STEADI criteria)
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 |
|---|---|---|
| Group ExerciseThe study evaluates two different approaches for group exercise. Participants in the Standard Implementation (SI) group complete the standard Walk with Ease intervention as recommended by the Arthritis Foundation. Participants are guided to learn and perform a series of stretching and strengthening exercises recommended in the base WWE program. Primary BCTs include instruction on how to perform behavior (#4.1) and Graded tasks (#8.7). Participants in the Enhanced Implementation (SI) group complete the standard Walk with Ease intervention as recommended by the Arthritis Foundation. They may perform some of the same exercises as those in the SI group but they are also guided to learn and perform specific exercises prescribed by a physical therapist to improve balance and reduce risks of falling. The primary BCTs include instruction on how to perform behavior (#4.1), Graded tasks (#8.7) from the base program as well as Information on health consequences (#5.1) and Credible source (#9.1). | Behavioural | Enhanced Implementation (EI), Standard Implementation (SI) |
| Behavioral TrainingThe study evaluates two different approaches for promoting behavior change. Participants in the Standard Training (ST) model follow the standardized Walk with Ease training to support behavior change. Participants are provided with goal setting tools and an online tracker to monitor their progress. Weekly video-based lessons, resource links and eBook content support behavior change. Primary BCTs include Goal Setting (BCT #1.1) and self-monitoring (BCT#2.3). Participants in the Enhanced Training (ET) model access the same basic content as the ST model, but the weekly education-based videos are replaced with lessons focus on habit-formation training. Student coaches are also assigned to individual participants to support behavior change efforts using motivational interviewing strategies. Thus, participants in the ET model also receive two additional theory- and evidence-based BCTs: (1) habit formation training (BCT#1.2, #1.4, #8.3) and (2 health coaching (BCT# 3.3). | Behavioural | Enhanced Training (ET), Standard Training (ST) |
Primary outcome
Change in Fall Risk
Time frame: 0, 6 weeks, 6 months, 12 months
Reported falls will be tracked using surveys as well as from the electronic medical record data. Reductions in fall risk will be evaluated using indicators from the established STEADI protocol with continuous fall risk scores computed using a validated algorithm.
Change in Physical Activity Behavior
Time frame: 0, 6 weeks, 6 months, 12 months
PA behavior will be captured using the International Physical Activity Questionnaire - Elderly (IPAQ-E) will be evaluated at all time points to estimate minutes of physical activity. While less robust than monitor-based methods, the IPAQ-E has been validated against criterion measures of physical activity and has demonstrated adequate sensitivity and specificity for evaluating physical activity among adults aged 65 years and older.
9 secondary outcomes
Change in Perceived Health
Time frame: 0, 6 weeks, 6 months, 12 months.
Change in Fear of Falling
Time frame: 0, 6 weeks, 6 months, 12 months.
Change in Physical Function
Time frame: 0, 6 weeks, 6 months, 12 months.
Change in Falls Efficacy
Time frame: 0, 6 weeks, 6 months, 12 months
Change in Capability (to exercise)
Time frame: 0, 6 weeks, 6 months, 12 months.
Change in Opportunity (to exercise)
Time frame: 0, 6 weeks, 6 months, 12 months.
Change in Motivation (to exercise)
Time frame: 0, 6 weeks, 6 months, 12 months.
Change in Enjoyment (of exercise)
Time frame: 0, 6 weeks, 6 months, 12 months
Change in Overall Strength
Time frame: 0, 6 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Derived from this study: PubMed 39342204Lamoureux NR, Lansing J, Dixon PM, Phillips LA, Radske-Suchan T, Dorneich MC, Chou LS, Welk GJ. Study protocol: process and outcome evaluation of the Walk with Ease program for fall prevention. BMC Public Health. 2024 Sep 28;24(1):2658. doi: 10.1186/s12889-024-20138-z.
- Individual participant dataSharing planned: Yes. The final dataset will include self-reported demographic data and individual behavioral data as well as clinical data from screening visits before and after intervention. All data will be stripped of identifiers so that the database will only retain coded ID numbers. We will make the data and associated documentation available to collaborating partners on the project including representatives from CHPcommunity, the Arthritis Foundation and the National Association of Chronic Disease Directors (NACDD) upon request. We will also make the data available to other users under data-sharing agreements that document a commitment to using the data only for research purposes.
Related trials for Exercise
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Not yet recruiting
Blood Parameter Changes Following Aerobic Exercise in Professional Soccer Players
Exercise Physiology, Blood Parameters
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Aquatic Versus Land-Based Exercise in Women With Lipedema
Lipedema
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.
Candis M. Hunter, Ph.D. study director
National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Group Exercise and Behavioral Training in people with Exercise and Frailty, run by Iowa State University 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Mar 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregory J. Welk, Ph.D. (515-294-3583, gwelk@iastate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fall Risk (time frame: 0, 6 weeks, 6 months, 12 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 NCT05693025, 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 7 Mar 2024.