Sedentary BehaviorNCT06667817
Exercise From Afar: Progressing At Risk Individuals to Independent Exercise
A study testing Exercise in people with Sedentary Behavior, run by Emporia State University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy of a technology-driven independent exercise program on health outcomes associated with dementia risk among underactive rural adults. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to 1 Sep 2025
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40 to 70 years of age
- Characterized as underactive by the TAPA
- Able to read and converse in English
- Willing and able to install an application on their smart phone
Who cannot join
- Myocardial infarction or symptoms of coronary artery disease in the last 2yrs
- Uncontrolled hypertension within the last 6 months
- Cancer in the last 2yrs (except non-metastatic basal or squamous cell carcinoma)
- Significant pain or musculoskeletal disorder that would prohibit participation in an exercise program
- Possible/probably dementia or mild cognitive impairment (MCI) base on adjudication
- Physician concern regarding safety or completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise From Afar: Progressing At-Risk Rural Adults to Effective Independent Exercise for Dementia Risk Reduction
The purpose of this study is to investigate the efficacy of a technology-driven independent exercise program on health outcomes associated with dementia risk among underactive rural adults.
Underactive adults (n=50), ages 40-70 years, from federally designated rural and frontier Kansas counties will be recruited to participate in this study. Specific inclusionary and exclusionary criteria will be used to screen potential participants and determine eligibility. Following recruitment and screening, participants will complete baseline physical fitness and health assessments, supervised by the research team. Following completion of baseline assessments, a personal training/fitness app will be employed to design and deliver exercise programming and track exercise participation, adherence and progression over the course of the study. All prescribed exercise will follow national governing body recommendations and include specific exercises found in previous work to be beneficial for physical health and brain plasticity. The study team will record exercise instruction videos that can be accessed by all participants at any time throughout the study. The particular app used will allow the research team to organize exercise videos into structured training sessions, allowing participants to exercise on their own, at the location of their choice, with ample instruction. The app will also allow participants to record themselves performing various exercises and send them to the research team for analysis of technique and safety. Communication between study personnel and participants will be delivered via the app. Phone calls and/or Zoom sessions will be offered as an alternative if necessary. Our goal is to create a safe, effective means of delivering personalized exercise programming to rural adults that reduces barriers to exercise, improves physical fitness and biomarkers associated with dementia risk and lends itself to exercise adherence in a population that is at an increased risk for cognitive decline. Middle aged adults will be included in the study as they are at an age when successful behavior change is more probable (than older, institutionalized adults); older adults will be included as they are in the high-risk category for dementia. Following the exercise intervention, all baseline assessments will be repeated. Data will be compared to determine the impact of the exercise program on each variable (i.e. dementia risk biomarkers, QOL, physical fitness, etc.).
Read the detailed description
Following screening, participants will complete baseline physical fitness and health assessments, supervised by the research team. This will require travel by the research team to various rural Kansas locations. The assessments will be those considered reliable, validated 'field tests' and can be easily administered with minimal exercise equipment. Assessments will include a submaximal VO2 field test to assess cardiorespiratory fitness, and an estimated 1 repetition maximum test to assess muscular strength.
Assessments will follow ACSM guidelines for safety and progression for middle aged and older adults.
Blood glucose and cholesterol levels will be measured as well, using a device commonly used in the field (Cholestek LDX ™) This device will assess total blood glucose, cholesterol, LDL, HDL and triglycerides. Additional baseline assessments may include, but are not limited to: a barriers to being active survey (BBAQ) and a perceived stress survey (PSS). All surveys are attached to this application.
Following completion of baseline assessments, participants will be randomized to one of two groups:
- Exercise (EX); This group will be given structured exercise programming for 16 weeks.
- Control (CON); This group will serve as the underactive control for this study. At the end of 16 weeks, they will be offered access to the same 16-week structured exercise program as the exercise group. CON participants will not be required to report any exercise data. Their use of the exercise program post-study will be completely voluntary and will not be used for data analysis purposes.
Smart Phone Application A personal training/fitness app will be installed on each participant's smart phone or tablet. The application used will be a highly-rated, commonly used fitness app and will be used in this study to design and deliver exercise programming and track exercise participation, adherence and progression over the course of the study. The study team will record exercise instruction videos that can be accessed by all participants at any time throughout the study. The particular app used will allow the research team to organize exercise videos into structured training sessions, allowing participants to exercise on their own, at the location of their choice, with ample instruction and plentiful exercise modification options.
The app will also allow participants to record themselves performing various exercises and send them to the research team for analysis of technique and safety. Communication between study personnel and participants will be delivered via the app. Phone calls and/or Zoom sessions will be offered as an alternative if necessary. During the initial project period (16 weeks), only the EX group will be given access to the structured exercise plan. Exercise Intervention The exercise intervention will consist of 3 evidence-based exercise sessions weekly for a total of 16 weeks. The target goal for all participants will be 75-150 minutes of aerobic exercise and 2-3 strength training sessions weekly. Exercise will be progressive in nature and participants will be encouraged to achieve the target goal for exercise by week 8 of the study and maintain the target goal for weeks 8-16.
All prescribed exercise will follow national governing body recommendations and include specific exercises found in previous work to be beneficial for physical health and brain plasticity. Following the exercise intervention, all baseline assessments will be repeated. Data will be compared to determine the impact of the exercise program on each variable (i.e. dementia risk biomarkers, BBAQ, PSS, and physical fitness.). In order to be included for data analysis, participants must complete 40 of the 48 exercise sessions (i.e. 83% of the sessions)
- Conditions
- Sedentary Behavior
- Being tested
- Exercise
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
16 weeks of exercise training (Exercise Group) will be prescribed via a smart phone application. Results from this group will be compared to results of the sedentary control group.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | This group will be assigned to the exercise group and will receive the exercise intervention, delivered via the smart phone application. Receives: Behavioral: Exercise |
| Control | No intervention | This group will complete all baseline and follow-up assessments, but receive no intervention. They will serve as the underactive control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Impact of a Technology-driven Exercise Program on Exercise Adherence.
Exercise adherence will be reported as the percentage of total exercise sessions completed over the course of the 16-week exercise study period. Exercise adherence will be tracked and recorded for EX participants only, since CON participants will not complete any exercise during the 16-week study period. The investigators hypothesize that Rural adults will report moderate to high adherence (70-80% total sessions completed) over the course of the study.
Measured: 16 weeks per participant enrolled
Determine the Impact of a Technology-driven Exercise Program on Barriers to Being Physical Active.
Participants will complete the BBAQ (Barriers to Being Active Quiz) at baseline and following 16 weeks of intervention or control (no exercise). Scores on the BBAQ represent the total number of barriers to physical activity participant report. The investigators hypothesize that EX participants will report fewer barriers to being active (lower BBAQ scores) following 16 weeks of the technology-driven exercise intervention. No change in barriers to physical activity is expected among CON participants.
Measured: 16 weeks per participant enrolled
Change in Exercise Self-Efficacy Scale (SEE) Score
Participants will complete the 9-item Exercise Self-Efficacy Scale (SEE) at baseline and following the 16-week exercise study period (following 16 weeks of intervention or control). Participants rated their confidence in their ability to exercise under various challenging circumstances. Each item was scored from 0 (not confident) to 10 (very confident). Item scores were summed to produce a total score ranging from 0 to 90, with higher scores indicating greater exercise self-efficacy. Change in SEE score was calculated as the post-intervention score minus the baseline score. Possible change scores range from -90 to +90, with positive values indicating improvement in exercise self-efficacy. The investigators hypothesize that Rural adults will report higher exercise self-efficacy following the intervention and that CON participants will not report changes in exercise self-efficacy.
Measured: 16 weeks per participant enrolled
Determine the Impact of a Technology-driven Exercise Program on Cholesterol and Fasting Blood Glucose.
Fasting blood glucose and cholesterol are measured simultaneously using a Cholestek device. This measure will be completed by all participants at baseline, and again at follow-up (following 16 weeks of intervention or control). The investigators hypothesize that participants in the EX group (exercise intervention) will see greater improvements in total cholesterol, fasting blood glucose and HDL following the intervention, compared to the CON group. The investigators expect that participants with higher exercise adherence will see the greatest improvements in these biomarkers associated with reduced dementia risk.
Measured: 16 weeks per participant enrolled
Determine the Impact of a Technology-driven Exercise Program on Cardiorespiratory Fitness.
Participants will also complete a common cardiorespiratory field test at baseline and again at follow-up (after 16 weeks of intervention or control). Cardiorespiratory fitness is reported as VO2max (ml/kg/min). The investigators hypothesize that cardiorespiratory fitness scores will improve for EX participants following the 16-week intervention and that the post-intervention cardiorespiratory field test scores will be significantly better than those of the CON group.
Measured: 16 weeks per participant enrolled
Determine the Impact of a Technology-driven Exercise Program on Muscular Fitness.
Participants will complete an estimated one repetition maximum (1RM) muscular fitness test for both upper body and lower body at baseline and again at follow-up (after 16 weeks of intervention or control). The investigators hypothesize that muscular fitness will improve for EX participants following the 16-week intervention and that the post-intervention muscular fitness results will be significantly better than those of the CON group.
Measured: 16 weeks per participant enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start31 Oct 2024
- Primary completion19 Aug 2025
- Study completion1 Sep 2025
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.
- Other trials for Sedentary BehaviorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emporia State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Erin Blocker, Emporia State University
- Investigators
- Erin M Blocker, PhD, Principal investigator, Emporia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667817
- Sponsor's protocol ID
- EmporiaStateU
- Other IDs
- P20GM103418
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2024
- Last updated
- 26 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise From Afar: Progressing At-Risk Rural Adults to Effective Independent Exercise for Dementia Risk Reduction
- ClinicalTrials.gov ID
- NCT06667817
- Acronym / sponsor ID
- EmporiaStateU
- Conditions
- Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Emporia State UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Posted 26 Oct 2026
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 study is to investigate the efficacy of a technology-driven independent exercise program on health outcomes associated with dementia risk among underactive rural adults.
Underactive adults (n=50), ages 40-70 years, from federally designated rural and frontier Kansas counties will be recruited to participate in this study. Specific inclusionary and exclusionary criteria will be used to screen potential participants and determine eligibility. Following recruitment and screening, participants will complete baseline physical fitness and health assessments, supervised by the research team. Following completion of baseline assessments, a personal training/fitness app will be employed to design and deliver exercise programming and track exercise participation, adherence and progression over the course of the study. All prescribed exercise will follow national governing body recommendations and include specific exercises found in previous work to be beneficial for physical health and brain plasticity. The study team will record exercise instruction videos that can be accessed by all participants at any time throughout the study. The particular app used will allow the research team to organize exercise videos into structured training sessions, allowing participants to exercise on their own, at the location of their choice, with ample instruction. The app will also allow participants to record themselves performing various exercises and send them to the research team for analysis of technique and safety. Communication between study personnel and participants will be delivered via the app. Phone calls and/or Zoom sessions will be offered as an alternative if necessary. Our goal is to create a safe, effective means of delivering personalized exercise programming to rural adults that reduces barriers to exercise, improves physical fitness and biomarkers associated with dementia risk and lends itself to exercise adherence in a population that is at an increased risk for cognitive decline. Middle aged adults will be included in the study as they are at an age when successful behavior change is more probable (than older, institutionalized adults); older adults will be included as they are in the high-risk category for dementia. Following the exercise intervention, all baseline assessments will be repeated. Data will be compared to determine the impact of the exercise program on each variable (i.e. dementia risk biomarkers, QOL, physical fitness, etc.).
Detailed description
Following screening, participants will complete baseline physical fitness and health assessments, supervised by the research team. This will require travel by the research team to various rural Kansas locations. The assessments will be those considered reliable, validated 'field tests' and can be easily administered with minimal exercise equipment. Assessments will include a submaximal VO2 field test to assess cardiorespiratory fitness, and an estimated 1 repetition maximum test to assess muscular strength.
Assessments will follow ACSM guidelines for safety and progression for middle aged and older adults.
Blood glucose and cholesterol levels will be measured as well, using a device commonly used in the field (Cholestek LDX ™) This device will assess total blood glucose, cholesterol, LDL, HDL and triglycerides. Additional baseline assessments may include, but are not limited to: a barriers to being active survey (BBAQ) and a perceived stress survey (PSS). All surveys are attached to this application.
Following completion of baseline assessments, participants will be randomized to one of two groups:
- Exercise (EX); This group will be given structured exercise programming for 16 weeks.
- Control (CON); This group will serve as the underactive control for this study. At the end of 16 weeks, they will be offered access to the same 16-week structured exercise program as the exercise group. CON participants will not be required to report any exercise data. Their use of the exercise program post-study will be completely voluntary and will not be used for data analysis purposes.
Smart Phone Application A personal training/fitness app will be installed on each participant's smart phone or tablet. The application used will be a highly-rated, commonly used fitness app and will be used in this study to design and deliver exercise programming and track exercise participation, adherence and progression over the course of the study. The study team will record exercise instruction videos that can be accessed by all participants at any time throughout the study. The particular app used will allow the research team to organize exercise videos into structured training sessions, allowing participants to exercise on their own, at the location of their choice, with ample instruction and plentiful exercise modification options.
The app will also allow participants to record themselves performing various exercises and send them to the research team for analysis of technique and safety. Communication between study personnel and participants will be delivered via the app. Phone calls and/or Zoom sessions will be offered as an alternative if necessary. During the initial project period (16 weeks), only the EX group will be given access to the structured exercise plan. Exercise Intervention The exercise intervention will consist of 3 evidence-based exercise sessions weekly for a total of 16 weeks. The target goal for all participants will be 75-150 minutes of aerobic exercise and 2-3 strength training sessions weekly. Exercise will be progressive in nature and participants will be encouraged to achieve the target goal for exercise by week 8 of the study and maintain the target goal for weeks 8-16.
All prescribed exercise will follow national governing body recommendations and include specific exercises found in previous work to be beneficial for physical health and brain plasticity. Following the exercise intervention, all baseline assessments will be repeated. Data will be compared to determine the impact of the exercise program on each variable (i.e. dementia risk biomarkers, BBAQ, PSS, and physical fitness.). In order to be included for data analysis, participants must complete 40 of the 48 exercise sessions (i.e. 83% of the sessions)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: ExerciseThis group will be assigned to the exercise group and will receive the exercise intervention, delivered via the smart phone application. |
| Control | No intervention | –This group will complete all baseline and follow-up assessments, but receive no intervention. They will serve as the underactive control. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40 to 70 years of age
- Characterized as underactive by the TAPA
- Able to read and converse in English
- Willing and able to install an application on their smart phone
Key exclusion criteria (6 listed)
- Myocardial infarction or symptoms of coronary artery disease in the last 2yrs
- Uncontrolled hypertension within the last 6 months
- Cancer in the last 2yrs (except non-metastatic basal or squamous cell carcinoma)
- Significant pain or musculoskeletal disorder that would prohibit participation in an exercise program
- Possible/probably dementia or mild cognitive impairment (MCI) base on adjudication
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 |
|---|---|---|
| Exercise16 weeks of exercise training (Exercise Group) will be prescribed via a smart phone application. Results from this group will be compared to results of the sedentary control group. | Behavioural | Exercise Group |
Primary outcome
Determine the Impact of a Technology-driven Exercise Program on Exercise Adherence.
Time frame: 16 weeks per participant enrolled
Exercise adherence will be reported as the percentage of total exercise sessions completed over the course of the 16-week exercise study period. Exercise adherence will be tracked and recorded for EX participants only, since CON participants will not complete any exercise during the 16-week study period. The investigators hypothesize that Rural adults will report moderate to high adherence (70-80% total sessions completed) over the course of the study.
Determine the Impact of a Technology-driven Exercise Program on Barriers to Being Physical Active.
Time frame: 16 weeks per participant enrolled
Participants will complete the BBAQ (Barriers to Being Active Quiz) at baseline and following 16 weeks of intervention or control (no exercise). Scores on the BBAQ represent the total number of barriers to physical activity participant report. The investigators hypothesize that EX participants will report fewer barriers to being active (lower BBAQ scores) following 16 weeks of the technology-driven exercise intervention. No change in barriers to physical activity is expected among CON participants.
Change in Exercise Self-Efficacy Scale (SEE) Score
Time frame: 16 weeks per participant enrolled
Participants will complete the 9-item Exercise Self-Efficacy Scale (SEE) at baseline and following the 16-week exercise study period (following 16 weeks of intervention or control). Participants rated their confidence in their ability to exercise under various challenging circumstances. Each item was scored from 0 (not confident) to 10 (very confident). Item scores were summed to produce a total score ranging from 0 to 90, with higher scores indicating greater exercise self-efficacy. Change in SEE score was calculated as the post-intervention score minus the baseline score. Possible change scores range from -90 to +90, with positive values indicating improvement in exercise self-efficacy. The investigators hypothesize that Rural adults will report higher exercise self-efficacy following the intervention and that CON participants will not report changes in exercise self-efficacy.
Determine the Impact of a Technology-driven Exercise Program on Cholesterol and Fasting Blood Glucose.
Time frame: 16 weeks per participant enrolled
Fasting blood glucose and cholesterol are measured simultaneously using a Cholestek device. This measure will be completed by all participants at baseline, and again at follow-up (following 16 weeks of intervention or control). The investigators hypothesize that participants in the EX group (exercise intervention) will see greater improvements in total cholesterol, fasting blood glucose and HDL following the intervention, compared to the CON group. The investigators expect that participants with higher exercise adherence will see the greatest improvements in these biomarkers associated with reduced dementia risk.
Determine the Impact of a Technology-driven Exercise Program on Cardiorespiratory Fitness.
Time frame: 16 weeks per participant enrolled
Participants will also complete a common cardiorespiratory field test at baseline and again at follow-up (after 16 weeks of intervention or control). Cardiorespiratory fitness is reported as VO2max (ml/kg/min). The investigators hypothesize that cardiorespiratory fitness scores will improve for EX participants following the 16-week intervention and that the post-intervention cardiorespiratory field test scores will be significantly better than those of the CON group.
Determine the Impact of a Technology-driven Exercise Program on Muscular Fitness.
Time frame: 16 weeks per participant enrolled
Participants will complete an estimated one repetition maximum (1RM) muscular fitness test for both upper body and lower body at baseline and again at follow-up (after 16 weeks of intervention or control). The investigators hypothesize that muscular fitness will improve for EX participants following the 16-week intervention and that the post-intervention muscular fitness results will be significantly better than those of the CON group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Erin M Blocker, PhD principal investigator
Emporia State 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 Exercise in people with Sedentary Behavior, run by Emporia 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 4 inclusion and 6 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 26 Oct 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?
Yes. Results are posted in the registry (first posted 26 Oct 2026). 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?
Determine the Impact of a Technology-driven Exercise Program on Exercise Adherence. (time frame: 16 weeks per participant enrolled). The study lists 6 primary outcomes in all. 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 26 Oct 2026.