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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a tech-driven exercise program can improve health markers associated with dementia risk in inactive adults living in rural areas. Participants will use a fitness app to follow a personalized exercise plan, which may enhance physical fitness and potentially reduce dementia risk. This study may suit adults who exercise infrequently, reside in rural Kansas, and are comfortable using a smartphone app for workouts. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could improve health outcomes for rural communities.

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 prior data suggests that this exercise program is safe for underactive adults?

Research has shown that regular exercise is safe and well-tolerated for most people. The World Health Organization recommends regular muscle-strengthening activities for everyone. Being active is not only safe but also beneficial, as it can reduce the risk of long-term illnesses and improve overall health.

In this study, participants will use a fitness app to guide their workouts. The exercises follow national guidelines, ensuring they are safe and effective. This approach allows individuals to exercise safely at their own pace.

Overall, exercise is a low-risk way to enhance health and reduce the likelihood of developing conditions like dementia. It is always important to pay attention to the body's signals and consult a healthcare provider if any concerns arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to combat sedentary lifestyles using a smartphone application to deliver an exercise program. Unlike traditional methods that often require in-person classes or gym memberships, this approach is convenient and accessible, allowing individuals to engage in physical activity from the comfort of their own homes. The digital delivery method can enhance motivation and adherence by providing personalized feedback and reminders, making it an appealing option for those who struggle to maintain regular exercise routines. By leveraging technology, this trial aims to find out if digital interventions can effectively promote healthier, more active lifestyles.

What evidence suggests that this exercise program is effective for reducing dementia risk?

Research has shown that regular exercise can greatly improve health, particularly for those at risk of dementia. This trial will compare an exercise intervention group with a control group receiving no intervention. Studies have found that people who do not exercise have a 20% to 30% higher risk of dying compared to those who exercise adequately. Physical activity is linked to a lower risk of frailty and improved brain health, which is crucial for reducing the risk of dementia. Furthermore, engaging in two to four times the recommended amount of moderate exercise can lower the risk of dying by up to 31%. These findings emphasize how exercise can boost physical fitness and help reduce factors leading to cognitive decline. ^{1 2 5 6 7}

Who Is on the Research Team?

Erin M Blocker, PhD

Principal Investigator

Emporia State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. who.int who.int/news-room/fact-sheets/detail/physical-activity

Physical activity People who are insufficiently active have a 20% to 30% increased risk of death compared to people who are sufficiently active.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7719906/

World Health Organization 2020 guidelines on physical ... The GDG concluded that the benefits of doing physical activity and limiting sedentary behaviour outweighed the potential harms. Any potential harms may be ...

3. ama-assn.org ama-assn.org/public-health/prevention-wellness/massive-study-uncovers-how-much-exercise-needed-live-longer

Massive study uncovers how much exercise is needed to ... Participants who performed two to four times above the recommended amount of moderate physical activity had a 26% to 31% lower all-cause mortality and a 28% to ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0939475325001255

A mutual interplay with early and overt frailty Sedentary behaviour and physical inactivity are strictly linked to frailty and pre-frailty, both in adults and the elderly, with or without chronic diseases.

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.125.325526

Epidemiology and Cardiovascular Benefits of Physical ... In this review, we focus on the beneficial effects of routine physical activity (PA) on the cardiovascular system, the different ways we can achieve and ...

6. cdc.gov cdc.gov/physical-activity/php/data/inactivity-maps.html

Adult Physical Inactivity Outside of Work Overall, combined data from 2017 through 2020 show physical inactivity prevalence of 25.3%. These maps reflect physical activity done outside of work. Color- ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814094

Occupational Sitting Time, Leisure Physical Activity, and All ... This cohort study examines the health outcomes associated with prolonged occupational sitting and assesses the additional amount of physical ...