Exercise Program for Sedentary Lifestyle

Overseen By Bryan Jones

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emporia State University

Disqualifiers: Myocardial infarction, Uncontrolled hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

50 Participants Needed

Trial Summary

What is the purpose of 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.).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on exercise, so it's likely you can continue your medications, but you should confirm with the study team.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for a sedentary lifestyle?

Research shows that increasing physical activity and exercise can improve heart health and reduce the risk of chronic diseases, especially cardiovascular disease. Studies also suggest that even moderate amounts of physical activity can lead to better health outcomes compared to a sedentary lifestyle. ^{1 2 3 4 5}

Is exercise generally safe for humans?

Exercise is generally safe for humans, but minor injuries like muscle strains can occur, especially in sedentary or older individuals. Serious problems are rare, and starting slowly with moderate intensity is recommended to minimize risks. ^{6 7 8 9 10}

How does the exercise treatment for a sedentary lifestyle differ from other treatments?

The exercise treatment for a sedentary lifestyle is unique because it focuses on increasing physical activity to improve overall health, rather than using medication. It enhances cardiovascular fitness, muscle strength, and flexibility, and can prevent chronic diseases like heart disease and diabetes, making it a holistic approach to health improvement. ^{11 12 13 14 15}

Research Team

Erin M Blocker, PhD

Principal Investigator

Emporia State University

Eligibility Criteria

This trial is for adults aged 40-70 living in rural Kansas who lead a sedentary lifestyle and are at risk of dementia. Participants must be able to use a fitness app or alternative communication methods like phone calls or Zoom for exercise guidance.

Inclusion Criteria

Able to read and converse in English

Willing and able to install an application on their smart phone

Characterized as underactive by the TAPA

Exclusion Criteria

Possible/probable dementia or mild cognitive impairment (MCI) based on adjudication

Physician concern regarding safety or completion of the study

My blood pressure has been stable for the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline physical fitness and health assessments

1 week

1 visit (in-person)

Exercise Intervention

Participants in the exercise group receive structured exercise programming for 16 weeks

16 weeks

Remote monitoring via app, optional phone/Zoom sessions

Control Period

Control group does not receive intervention but completes assessments

16 weeks

Follow-up

Participants are monitored for changes in health outcomes and repeat baseline assessments

1 week

1 visit (in-person)

Treatment Details

Interventions

• Exercise

Trial Overview The study tests the effectiveness of an app-based independent exercise program on physical health and potential dementia risk reduction. It includes personalized exercises, instructional videos, technique analysis, with the goal of improving fitness and encouraging long-term exercise habits.

Participant Groups

Group I: Exercise Group Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

This group will complete all baseline and follow-up assessments, but receive no intervention. They will serve as the underactive control.

Who Is Running the Clinical Trial?

Emporia State University

Lead Sponsor

Trials

1

Recruited

50+

Findings from Research

Sedentary behavior and physical inactivity are major risk factors for cardiovascular disease and overall mortality, highlighting the urgent need for increased physical activity across all demographics.

Improving cardiorespiratory fitness through exercise training is essential for preventing chronic diseases, particularly cardiovascular issues, and should be prioritized in healthcare strategies globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedentary Behavior, Exercise, and Cardiovascular Health. Lavie, CJ., Ozemek, C., Carbone, S., et al.[2019]

Older veterans who regularly participate in an outpatient exercise program perform at average or slightly above average levels in physical function tests compared to national norms, indicating the efficacy of regular physical activity.

In contrast, sedentary older veterans scored significantly lower in physical function tests, highlighting the importance of exercise for maintaining health and function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical function in sedentary and exercising older veterans as compared to national norms. Peterson, MJ., Crowley, GM., Sullivan, RJ., et al.[2019]

Sedentary and unfit lifestyles significantly increase the risk of chronic diseases and functional limitations as people age, highlighting the importance of physical activity for overall health.

Even moderate amounts of physical activity can lead to improved health outcomes and reduced risks of morbidity and mortality, suggesting that encouraging the most sedentary 20-25% of the population to engage in at least moderate activity can provide substantial public health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How much physical activity should we do? The case for moderate amounts and intensities of physical activity. Blair, SN., Connelly, JC.[2007]

The study successfully integrated a 4-week intervention to reduce sedentary time into a pulmonary rehabilitation program for individuals with chronic obstructive pulmonary disease, with a high completion rate of 90% among participants.

Participants reported a high satisfaction score of 90 out of 100, and 56% of the intervention goals were achieved, indicating that while the intervention was feasible, its effectiveness in reducing sedentary time needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embedding a Behavior Change Program Designed to Reduce Sedentary Time Within a Pulmonary Rehabilitation Program Is Feasible in People With COPD. Wshah, A., Selzler, AM., Hill, K., et al.[2022]

A novel Internet-mediated, pedometer-based exercise intervention for veterans with COPD led to significant improvements in health-related quality of life (HRQL) domains, particularly in Symptoms and Impact, after 4 months.

Participants in the intervention group increased their daily step counts by an average of 779 steps compared to the control group, indicating that the program effectively encouraged physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. Moy, ML., Collins, RJ., Martinez, CH., et al.[2022]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

Vigorous physical activity can increase the risk of cardiovascular and musculoskeletal complications, especially in sedentary individuals with pre-existing heart conditions, with relative risks of exercise-related cardiac events ranging from 2.1 to 56.

While exercise is generally beneficial for heart health, there is a potential for both underdosing and overdosing, suggesting that there is an optimal level of exercise beyond which the risks may outweigh the benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting the benefits and risks of aerobic exercise in perspective. Franklin, BA., Billecke, S.[2022]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

The American College of Sports Medicine's guidelines for exercise training have historically focused on enhancing aerobic capacity and body composition, but recent research suggests they may not fully address the health needs of sedentary adults.

A new approach emphasizes promoting general physical activity over strict exercise training, as studies show that a more active lifestyle is linked to better health outcomes, longevity, and performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

J.B. Wolffe Memorial Lecture. Health consequences of physical activity: understanding and challenges regarding dose-response. Haskell, WL.[2019]

Physical activity programs, particularly noncontact and noncompetitive aerobic exercises like walking, running, and bicycling, are recommended for individuals over 35 to help delay the progression of age-related degenerative diseases.

These programs are designed to maintain a sustained cardiac rate of 70% of an individual's work capacity, making them accessible and low-cost options for improving health in deconditioned individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activities: teaming up patients and programs. Blocker, WP.[2019]

A sedentary lifestyle is a major risk factor for cardiovascular events, while regular physical activity significantly reduces the risk of coronary heart disease and other conditions like diabetes and hypertension.

Cardiac rehabilitation programs that include structured exercise not only improve physical fitness and quality of life but also reduce long-term mortality by 20-25%, highlighting the importance of exercise in health promotion and disease prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity and cardiovascular health a close link]. Fattirolli, F., Cellai, T., Burgisser, C.[2022]

A physically active lifestyle significantly reduces the risk of chronic diseases, but sedentary individuals must be assessed for their risk of traumatic events before starting exercise programs.

Risk stratification helps tailor exercise prescriptions based on individual health status, ensuring safe and effective physical activity that can improve cardiovascular fitness, body composition, and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing and prescription. Practical recommendations for the sedentary. King, CN., Senn, MD.[2018]

Regular physical activity significantly slows the decline in health and fitness parameters in older adults, with evidence showing that even moderate exercises like walking and swimming can maintain cardiovascular and musculoskeletal fitness.

Sedentary older individuals can achieve substantial improvements in muscle strength and aerobic capacity by starting gentle exercise programs at least three times a week, highlighting the importance of accessible and enjoyable fitness activities for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and the older person. Ward, J.[2004]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sedentary Behavior, Exercise, and Cardiovascular Health. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Physical function in sedentary and exercising older veterans as compared to national norms. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

How much physical activity should we do? The case for moderate amounts and intensities of physical activity. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

Embedding a Behavior Change Program Designed to Reduce Sedentary Time Within a Pulmonary Rehabilitation Program Is Feasible in People With COPD. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Putting the benefits and risks of aerobic exercise in perspective. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. [2015]

10. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

J.B. Wolffe Memorial Lecture. Health consequences of physical activity: understanding and challenges regarding dose-response. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Physical activities: teaming up patients and programs. [2019]

13. Italy pubmed.ncbi.nlm.nih.gov

[Physical activity and cardiovascular health a close link]. [2022]

14. New Zealand pubmed.ncbi.nlm.nih.gov

Exercise testing and prescription. Practical recommendations for the sedentary. [2018]

15. Australia pubmed.ncbi.nlm.nih.gov

Exercise and the older person. [2004]