Exercise From Afar: Progressing At Risk Individuals to Independent Exercise

NCT06667817 | Recruiting

• 1 other identifier: EmporiaStateU
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.).

Conditions

Sedentary Behavior

Outcome Measures

Primary Outcomes (6)

• 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.

  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 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.

  16 weeks per participant enrolled

• 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).

  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 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.

  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). 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.

  16 weeks per participant enrolled

• Determine the impact of a technology-driven exercise program on muscular fitness.

  Participants will complete an repetition maximum muscular fitness test 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.

  16 weeks per participant enrolled

Study Arms (2)

Exercise Group

EXPERIMENTAL

This group will be assigned to the exercise group and will receive the exercise intervention, delivered via the smart phone application.

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.

Interventions

Exercise BEHAVIORAL

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.

Exercise Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emporia State University: lead

Study Sites (1)

Emporia State University

Emporia, Kansas, 66801, United States

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Erin M Blocker, PhD

  Emporia State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin M Blocker, PhD

CONTACT

620-803-6161; eblocker@emporia.edu

Bryan Jones

CONTACT

620-341-5351; bjones17@emporia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be aware of which study group they are assigned to. Investigators will also be aware of what study group participants are assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: October 31, 2024
• Study Start: October 31, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

US (1)