Exercise From Afar: Progressing At Risk Individuals to Independent Exercise
ConditionSedentary Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorEmporia State University
About this trial
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.).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Behavioral16 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Exercise GroupExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Determine the impact of a technology-driven exercise program on exercise adherence.
Exercise log data will be used to determine 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.
Time frame
16 weeks per participant enrolled2
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 the 16-week exercise study period (following 16 weeks of intervention or control). The results will be compared to determine statistical differences, if any, in barriers to participating in exercise between time points and between groups (EX vs CON). Participants assigned to the exercise group will log their exercise using the smart phone application for the entire 16-week study period. Higher scores on the BBAQ equate to a greater number of barriers to being active. The investigators hypothesize that Rural adults will report fewer barriers to being active (lower BBAQ scores) following 16 weeks of the technology-driven exercise intervention.
Time frame
16 weeks per participant enrolled3
Determine the impact of a technology-driven exercise program on exercise self-efficacy.
Participants will complete the Exercise Self-Efficacy Scale at baseline and following the 16-week exercise study period (following 16 weeks of intervention or control). The results will be compared to determine statistical differences, if any, between time points and between groups (EX vs CON). The investigators hypothesize that Rural adults will report higher exercise self-efficacy (higher Self-Efficacy Scale scores) following the intervention (compared to CON participants).
Time frame
16 weeks per participant enrolled4
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 LDL 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.
Time frame
16 weeks per participant enrolledSponsors and contacts
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Source ClinicalTrials.gov