MotivationNCT06071130
Connecting Socioemotional Aspects of Exercise to Improvements in Physical Health Among Older Adults
A study testing Fit and Strong in people with Motivation and Aging, run by DePaul University at 1 site in United States.
Trial summary
Exercise is routinely recommended because of its benefits for physical, cognitive, and mental health. It is especially beneficial for older adults due to its potential buffering effects against Alzheimer's disease and related dementias (Luck et al., 2014). Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivation, Aging, Health Behavior
- What is being tested?
- Fit and Strong
- 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
- 21 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Experiment 4A: We will follow the standard exclusion protocol used in previous Fit \& Strong! studies (e.g., Hughes et al., 2004; 2006). The participant's physician will be contacted for clearance to participate if they have a history of high blood pressure, or experience dizziness, lightheadedness, or chest pain or pressure during physical activities (walking, climbing stairs, and household chores, etc.) (see document: "E4_NeedforPhysicianScreeningQuestionnaire.docx"). Additionally, physicians will be contacted if participants indicate that they fall, feel unsteady, or use an assistive walking or standing device. For these conditions and any special considerations that a participant may express, physicians will be contacted for clearance.
- Experiment 4B: Only participants who participated in Experiment 4A are eligible to participate in Experiment 4B.
Who cannot join
- Experiment 4A: We will follow the standard exclusion protocol used in previous Fit \& Strong! studies (e.g., Hughes et al., 2004; 2006). For instance, participants will be excluded for joint steroid injections within 3 months, knee or hip surgery within the previous 6 months or next year, rheumatoid arthritis or other systemic inflammatory arthritis, or uncontrolled diabetes. The participant's physician will be contacted for clearance to participate if they have a history of high blood pressure, or experience dizziness, lightheadedness, or chest pain or pressure during physical activities (walking, climbing stairs, and household chores, etc.) (see document: "E4_NeedforPhysicianScreeningQuestionnaire.docx"). Additionally, physicians will be contacted if participants indicate that they fall, feel unsteady, or use an assistive walking or standing device. For these conditions and any special considerations that a participant may express, physicians will be contacted for clearance (see document: "StatementofMedicalClearanceforExercise.docx" and "CoverLetterforMedicalClearanceforExercise.docx").
- Experiment 4B: Participants who did not participate in Experiment 4A are not eligible to participate in Experiment 4B.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Exercise is routinely recommended because of its benefits for physical, cognitive, and mental health. It is especially beneficial for older adults due to its potential buffering effects against Alzheimer's disease and related dementias (Luck et al., 2014). However, little is known about how to best encourage older adults to exercise. Based on behavior change theory, different intrapersonal and interpersonal motivational factors are likely to be relevant during the contemplation, action, and maintenance stages of behavior change. Generally, as a result of motivational shifts toward prioritizing positivity and socially meaningful goals with advancing age (Carstensen, 2006), socioemotional aspects of decision making may become more salient and influential for older adults (Mikels et al., 2015; Peter et al., 2011). Our previous work has demonstrated that positive affect (Mikels et al., 2020) and social goals (Steltenpohl et al., 2019) play a critical role in older adults' motivation to exercise, but these two lines of research have not been integrated to date. Recent work indicates that positive affect is particularly beneficial for health when shared in social connections (Fredrickson, 2016; Major et al., 2018), and the proposed work will, for the first time, examine how shared interpersonal positivity may impact exercise decision making and behavior, especially during the contemplation and action/maintenance stages of behavior change.
But who are the older adults that benefit the most from exercise in terms of physical, cognitive, and mental health (and should be hence be targeted with messages)? Not all older adults reap the benefits of exercise (Sparks, 2014) and, conversely, sedentary older adults have the most to gain. Overall, the current proposed research program is innovative in its (a) translational application of insights from affective, cognitive, and aging theory and research to understand the antecedents and outcomes of exercise decision making in younger and older adults, (b) conceptualization of both the social and emotional aspects of decision making, (c) development of novel methods for health messaging that incorporate social influences, and (d) novel assessments of the exercise-health link.
Read the detailed description
Our specific aims are:
Aim 1: To understand how social and emotional processes contribute to age differences in health-related decision making. Message framing is an effective means of promoting behavior change, with loss-framing emphasizing the negative consequences of not engaging in a behavior, and gain-framing emphasizing the benefits of engaging in a behavior (Rothman \& Salovey, 1997). Although affect has been examined in messaging, intrapersonal vs. interpersonal benefits and consequences as well as the role of shared positive affect have not. We propose that interpersonal vs. intrapersonal framing will differentially influence positivity toward exercise for sedentary and active older vs. younger adults. Experiment 1 (laboratory-based) will examine affective reactions, evaluations, and behavioral intentions in response to framed messages. To better understand the social processes involved in exercise decisions, Experiment 2 (field-based) will examine the same outcomes of Experiment 1 when people exercise alone or with another person, with a focus on whether shared positive affect is more motivating for older vs. younger adults when engaged in physical activity.
Aim 2: To determine how social and emotional factors impact exercise engagement, adherence, and maintenance. Experiments 3, 4A, and 4B will examine whether intrapersonal vs. interpersonal factors disproportionately impact exercise intentions and behavior. In Experiment 3, intrapersonal vs. interpersonal framing will be applied to recruit and enroll younger and older adults into an exercise program. In Experiment 4A, we will examine whether social and emotional factors - including shared positive affect - influence the engagement and adherence of older adults enrolled in an evidence-based fitness program, Fit \& Strong! (Hughes et al., 2006). In Experiment 4B, we will measure social and emotional influences on continued physical activity one year after the program ends. In these latter two experiments, we will measure actual behavioral outcomes including objective measures of physical activity and attendance, as well as shared positive affect, cognitive function, and well-being.
Aim 3: To extend the established benefits of Fit \& Strong! for older adults into physiological and cognitive domains. It is well-established that exercise improves physical, mental, and cognitive health (Hillman et al., 2008; Hughes et al., 2006). We will expand the documented benefits of a particular exercise intervention tailored for older adults, Fit \& Strong!, by examining its impact on cardiovascular, somatic physiological, social, and cognitive outcomes.
- Conditions
- Motivation, Aging, Health Behavior, Emotions, Social Behavior
- Being tested
- Fit and Strong
- Medical subject headings
- Health Behavior, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit and StrongBehavioural
Procedure: During Years 3-5, participants will be recruited in waves through our standard recruitment practices to participate in Experiments 4A at the City of Chicago park sites. We will first prescreen them via telephone to verify that potential participants meet the inclusion criteria. F\&S! classes will be offered at two pre-determined Chicago park sites. Each of the two sites will host the 8-week-long program once in the spring and once in the fall for two years for a total of four F\&S! cycles at each center (totaling 8 F\&S! cohorts). Upon consenting to be in E4A, participants will be enrolled in F\&S! at the site closest to their home or the wait-list control. In the pre-intervention phase, participants both in F\&S! and on the waitlist will come to the lab at DePaul to complete the pre-intervention measurement batter. Within one week after baseline measurements, participants will attend F\&S! for 3 sessions a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experiment 4A & 4B | Experimental | Participants will attend for 3 sessions/week for 8 weeks. Instructors will conduct classes and maintain participant attendance records. Exercise components include flexibility, aerobics, strengthening, and physical activity logs. Classes begin and end with 10-minute warmups and cool downs. Participants are taught low-impact aerobic routines to maximize self-efficacy for physical activity maintenance after the program. This will include fitness walking that will progress from each participant's maximum capacity to the goal of 20 minutes of sustained walking. Participants will be instructed on how to gauge their exercise intensity and physical exertion. The strengthening focus of the program will improve independent functioning by targeting lower extremity strength with a graded, task-specific approach. Resistance will be progressively increased over the course of the program by adding weight. At the end of each exercise session, participants will log physical activity. Receives: Behavioral: Fit and Strong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Connecting Socioemotional Aspects of Exercise to Improvements in Physical Health among Older Adults
Materials \& Measures for Pre- and Post-Intervention: The measurement battery will include: a basic demographic form, a cognitive battery in addition to several oral inductive reasoning measures: Letter Sets and Figure Classification, and Everyday Problem Solving. We will also administer measures of physical activity related variables that have been collected in previous Fit \& Strong! studies, which include: a paper measure of self-efficacy for arthritis self-management, a paper measure of exercise adherence self-efficacy, an oral functional lower extremity muscle strength, 6-minute distance walk in which we measure how far a participant walks in 6 minutes, and a paper version of the Western Ontario and McMasters University Osteoarthritis Index.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start21 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DePaul University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Mikels, PhD, Principal investigator, DePaul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071130
- Sponsor's protocol ID
- IRB-2021-520
- Status last verified
- Aug 2026
- First submitted
- 3 Oct 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Socioemotional Aspects of Exercise to Improvements in Physical Health Among Older Adults
- ClinicalTrials.gov ID
- NCT06071130
- Acronym / sponsor ID
- IRB-2021-520
- Conditions
- Motivation, Aging, Health Behavior, Emotions, Social Behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- DePaul UniversityUniversity, hospital or other
- Study start
- 21 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Oct 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.
Exercise is routinely recommended because of its benefits for physical, cognitive, and mental health. It is especially beneficial for older adults due to its potential buffering effects against Alzheimer's disease and related dementias (Luck et al., 2014). However, little is known about how to best encourage older adults to exercise. Based on behavior change theory, different intrapersonal and interpersonal motivational factors are likely to be relevant during the contemplation, action, and maintenance stages of behavior change. Generally, as a result of motivational shifts toward prioritizing positivity and socially meaningful goals with advancing age (Carstensen, 2006), socioemotional aspects of decision making may become more salient and influential for older adults (Mikels et al., 2015; Peter et al., 2011). Our previous work has demonstrated that positive affect (Mikels et al., 2020) and social goals (Steltenpohl et al., 2019) play a critical role in older adults' motivation to exercise, but these two lines of research have not been integrated to date. Recent work indicates that positive affect is particularly beneficial for health when shared in social connections (Fredrickson, 2016; Major et al., 2018), and the proposed work will, for the first time, examine how shared interpersonal positivity may impact exercise decision making and behavior, especially during the contemplation and action/maintenance stages of behavior change.
But who are the older adults that benefit the most from exercise in terms of physical, cognitive, and mental health (and should be hence be targeted with messages)? Not all older adults reap the benefits of exercise (Sparks, 2014) and, conversely, sedentary older adults have the most to gain. Overall, the current proposed research program is innovative in its (a) translational application of insights from affective, cognitive, and aging theory and research to understand the antecedents and outcomes of exercise decision making in younger and older adults, (b) conceptualization of both the social and emotional aspects of decision making, (c) development of novel methods for health messaging that incorporate social influences, and (d) novel assessments of the exercise-health link.
Detailed description
Our specific aims are:
Aim 1: To understand how social and emotional processes contribute to age differences in health-related decision making. Message framing is an effective means of promoting behavior change, with loss-framing emphasizing the negative consequences of not engaging in a behavior, and gain-framing emphasizing the benefits of engaging in a behavior (Rothman \& Salovey, 1997). Although affect has been examined in messaging, intrapersonal vs. interpersonal benefits and consequences as well as the role of shared positive affect have not. We propose that interpersonal vs. intrapersonal framing will differentially influence positivity toward exercise for sedentary and active older vs. younger adults. Experiment 1 (laboratory-based) will examine affective reactions, evaluations, and behavioral intentions in response to framed messages. To better understand the social processes involved in exercise decisions, Experiment 2 (field-based) will examine the same outcomes of Experiment 1 when people exercise alone or with another person, with a focus on whether shared positive affect is more motivating for older vs. younger adults when engaged in physical activity.
Aim 2: To determine how social and emotional factors impact exercise engagement, adherence, and maintenance. Experiments 3, 4A, and 4B will examine whether intrapersonal vs. interpersonal factors disproportionately impact exercise intentions and behavior. In Experiment 3, intrapersonal vs. interpersonal framing will be applied to recruit and enroll younger and older adults into an exercise program. In Experiment 4A, we will examine whether social and emotional factors - including shared positive affect - influence the engagement and adherence of older adults enrolled in an evidence-based fitness program, Fit \& Strong! (Hughes et al., 2006). In Experiment 4B, we will measure social and emotional influences on continued physical activity one year after the program ends. In these latter two experiments, we will measure actual behavioral outcomes including objective measures of physical activity and attendance, as well as shared positive affect, cognitive function, and well-being.
Aim 3: To extend the established benefits of Fit \& Strong! for older adults into physiological and cognitive domains. It is well-established that exercise improves physical, mental, and cognitive health (Hillman et al., 2008; Hughes et al., 2006). We will expand the documented benefits of a particular exercise intervention tailored for older adults, Fit \& Strong!, by examining its impact on cardiovascular, somatic physiological, social, and cognitive outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment 4A & 4B | Experimental | Behavioral: Fit and StrongParticipants will attend for 3 sessions/week for 8 weeks. Instructors will conduct classes and maintain participant attendance records. Exercise components include flexibility, aerobics, strengthening, and physical activity logs. Classes begin and end with 10-minute warmups and cool downs. Participants are taught low-impact aerobic routines to maximize self-efficacy for physical activity maintenance after the program. This will include fitness walking that will progress from each participant's maximum capacity to the goal of 20 minutes of sustained walking. Participants will be instructed on how to gauge their exercise intensity and physical exertion. The strengthening focus of the program will improve independent functioning by targeting lower extremity strength with a graded, task-specific approach. Resistance will be progressively increased over the course of the program by adding weight. At the end of each exercise session, participants will log physical activity. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Experiment 4A: We will follow the standard exclusion protocol used in previous Fit \& Strong! studies (e.g., Hughes et al., 2004; 2006). The participant's physician will be contacted for clearance to participate if they have a history of high blood pressure, or experience dizziness, lightheadedness, or chest pain or pressure during physical activities (walking, climbing stairs, and household chores, etc.) (see document: "E4_NeedforPhysicianScreeningQuestionnaire.docx"). Additionally, physicians will be contacted if participants indicate that they fall, feel unsteady, or use an assistive walking or standing device. For these conditions and any special considerations that a participant may express, physicians will be contacted for clearance.
- Experiment 4B: Only participants who participated in Experiment 4A are eligible to participate in Experiment 4B.
Key exclusion criteria (2 listed)
- Experiment 4A: We will follow the standard exclusion protocol used in previous Fit \& Strong! studies (e.g., Hughes et al., 2004; 2006). For instance, participants will be excluded for joint steroid injections within 3 months, knee or hip surgery within the previous 6 months or next year, rheumatoid arthritis or other systemic inflammatory arthritis, or uncontrolled diabetes. The participant's physician will be contacted for clearance to participate if they have a history of high blood pressure, or experience dizziness, lightheadedness, or chest pain or pressure during physical activities (walking, climbing stairs, and household chores, etc.) (see document: "E4_NeedforPhysicianScreeningQuestionnaire.docx"). Additionally, physicians will be contacted if participants indicate that they fall, feel unsteady, or use an assistive walking or standing device. For these conditions and any special considerations that a participant may express, physicians will be contacted for clearance (see document: "StatementofMedicalClearanceforExercise.docx" and "CoverLetterforMedicalClearanceforExercise.docx").
- Experiment 4B: Participants who did not participate in Experiment 4A are not eligible to participate in Experiment 4B.
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 |
|---|---|---|
| Fit and StrongProcedure: During Years 3-5, participants will be recruited in waves through our standard recruitment practices to participate in Experiments 4A at the City of Chicago park sites. We will first prescreen them via telephone to verify that potential participants meet the inclusion criteria. F\&S! classes will be offered at two pre-determined Chicago park sites. Each of the two sites will host the 8-week-long program once in the spring and once in the fall for two years for a total of four F\&S! cycles at each center (totaling 8 F\&S! cohorts). Upon consenting to be in E4A, participants will be enrolled in F\&S! at the site closest to their home or the wait-list control. In the pre-intervention phase, participants both in F\&S! and on the waitlist will come to the lab at DePaul to complete the pre-intervention measurement batter. Within one week after baseline measurements, participants will attend F\&S! for 3 sessions a week for 8 weeks. | Behavioural | Experiment 4A & 4B |
Primary outcome
Connecting Socioemotional Aspects of Exercise to Improvements in Physical Health among Older Adults
Time frame: two years
Materials \& Measures for Pre- and Post-Intervention: The measurement battery will include: a basic demographic form, a cognitive battery in addition to several oral inductive reasoning measures: Letter Sets and Figure Classification, and Everyday Problem Solving. We will also administer measures of physical activity related variables that have been collected in previous Fit \& Strong! studies, which include: a paper measure of self-efficacy for arthritis self-management, a paper measure of exercise adherence self-efficacy, an oral functional lower extremity muscle strength, 6-minute distance walk in which we measure how far a participant walks in 6 minutes, and a paper version of the Western Ontario and McMasters University Osteoarthritis Index.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Joseph Mikels, PhD principal investigator
DePaul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit and Strong in people with Motivation and Aging, run by DePaul 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: opening soon, as of the sponsor's last update on 28 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Mikels, PhD (773-325-8769, jmikels@depaul.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Connecting Socioemotional Aspects of Exercise to Improvements in Physical Health among Older Adults (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2026.