Clinical Research Directory

Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health

The purpose of this Phase 1 research study is to answer two questions: (1) How frequent should periods of prolonged sedentary time be interrupted? and (2) What is the appropriate duration or length of time of these breaks in sedentary time? To address these questions, this project will conduct a state-of-the-art adaptive dose finding study under controlled laboratory conditions to determine the minimally effective dose (the smallest dose) that yields cardiometabolic benefit for two separate sedentary break elements (frequency and duration). Study findings will ultimately determine how often and for how long people should break up periods of prolonged sedentary time to transiently improve established cardiovascular risk factors; key foundational information critical to the success of future long-term trials and ultimately public health guidelines. Primary Aim: To determine the minimally effective dose combination(s) of frequency and duration needed to provide cardiometabolic benefit during an 8-hour experimentation period. Specifically, the study will determine: 1a. For each fixed duration, the minimum sedentary break frequency (e.g., every 30 min, 60 min, 120 min) that demonstrates a reduction in systolic BP, diastolic BP, or glucose compared with a sedentary control condition. 1b. For each fixed frequency, the minimum sedentary break duration (e.g., activity breaks of 1 min, 5 min, 10 min) that demonstrates a reduction in systolic BP, diastolic BP, or glucose compared with a sedentary control. Secondary Aim: It is also critical to public health strategy to assess the acceptability/feasibility of various sedentary break doses as too high a dose will yield poor uptake. To address this need, the maximally tolerated dose (the highest dose that does not cause undue physical/psychological distress) for frequency and duration of sedentary breaks will also be determined via assessment of 4 constructs: physical exhaustion/fatigue, affect (e.g., mood, emotion), tolerability (e.g., completion of dose protocol), and safety (e.g., hypoglycemia). Maximally tolerated dose will be defined as the highest dose where \<20% of participants exhibit an adverse outcome.

Promoting Physical Activity in Older Hispanic/Latino(a) Adults

In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California and from Kaiser Permanente Washington (State) to either the culturally adapted De Pie physical activity intervention or an active comparison program focusing on general brain health topics. The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit strength, social support, and enjoyment for physical activity (PA), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week).

Sitting Interruption and Whole-body Cardiovascular Health

There is strong evidence for the association between sedentary behaviors and cardiovascular diseases such as coronary heart disease and stroke. However, the public currently has no clear guidance on how to limit or interrupt their sedentary behaviors. This study will identify and test the physiological effects of several sedentary behavior interruption strategies and explore the feasibility (i.e., likelihood of an individual performing the requested activities) of those strategies to inform the development of public policy surrounding sedentary behavior interruption. Long-term, the findings of this study will inform a large clinical trial that can test whether sedentary behavior reduction can decrease cardiovascular disease risk.

Effectiveness of Interventions to Promote Physical Activity During Pregnancy

Pregnant women are more sedentary (sit, recline, lie down more) on average than non-pregnant women (more than 12 versus less than 8 waking sedentary hours/day). Sedentary behavior has been related to psychological distress, pregnancy weight gain, impaired sleep and very large size infants, while adequate physical activity has been found to improve mental health, decrease risk of high blood pressure in pregnancy and lower risk of preterm birth infants (less than 37 weeks gestation). Decreased sedentary behavior and increased physical activity may be crucial and neglected lifestyle behavior changes that can be promoted to reduce these and other maternal health and birth outcome problems among pregnant women.

Increasing Physical Activity Through Social Support and Stress Resilience

The goal of this clinical trial is to learn the effects of technology enhancements when combined with basic education, goal-setting, and self-monitoring to increase physical activity among older adults living alone, experiencing subjective cognitive decline, and currently engaging minimal physical activity (60 minutes or less of moderate to vigorous physical activity). Further, we will examine key psychosocial mechanisms believed to contribute to successful promotion of physical activity, which include social support and stress resilience. The primary questions are to determine whether * the tech-enhanced condition lead to greater physical activity over time? * the tech-enhanced condition lead to social support and stress resilience over time? * social support and stress resilience mediate the relationship between the study condition and physical activity? All participants will engage in self-monitoring of physical activity, will receive weekly text reminders of their physical activity goals for the week, and will receive basic education about the importance of physical activity, social support, and stress resilience for cognitive, physical, and psychological health. Participants in the tech-enhanced condition will also receive access to a study-specific website and virtual coaching to reinforce the information presented. Researchers will then compare the tech-enhanced condition to the basic education condition to determine the benefits of technology to deliver the intervention materials in order to increase physical activity, social support, and stress resilience. Participants will: * Use a Garmin wearable device to monitor their physical activity * Be randomly assigned to a basic education condition or tech-enhanced condition * Set achievable goals for weekly physical activity, with incremental increases to achieve 7000 average daily steps by the end of the study * Respond to surveys to monitor their social support, stress resilience, quality of life, and depression. The sample has several risk factors for Alzheimer's disease and related dementias: low physical activity, social isolation risk via living alone, and subjective cognitive impairment. Therefore, a long-term goal includes the determination of the intervention's effectiveness at increasing physical activity, social support, and stress resilience to reduce risk for developing dementia.

Physical Fitness Assessment in Professional and Amateur E-Sports Players

The aim of this observational cross-sectional study is to compare the physical fitness characteristics of professional and amateur e-sports players and to determine whether differences exist between the two groups in terms of physical fitness parameters.

Lumbar Stabilization Exercises in Sedentary Adults

This pilot randomized controlled trial will examine the effects of a four-week lumbar spine stabilization exercise program on motor control, dynamic balance, and quality of life in healthy sedentary adults. Prolonged sedentary behavior has been associated with impaired neuromuscular function and increased risk of musculoskeletal disorders, even in asymptomatic individuals. Forty sedentary adults will be randomly assigned to either an intervention group, which will follow a structured lumbar stabilization exercise program, or to a control group, which will receive ergonomic and stretching guidelines. Outcomes will be assessed before and after the intervention using the SF-12v2 quality of life questionnaire, the Functional Movement Screen (FMS) and the Y-Balance Test. Physical activity levels will be monitored using the IPAQ-SF. The study aims to determine whether lumbar stabilization exercises improve health-related quality of life, motor control and dynamic balance in sedentary adults.

Families Implementing Good Health Traditions for Life

This study will provide evidence for the utility of using a community-engaged research approach to implement a tailored, family-oriented adaptation of the Diabetes Prevention Program that will have positive effects on risk factors associated with type 2 diabetes morbidity and mortality among Black families in a Southwest Georgia community.

A BCT Intervention for an Hourly Activity Habit Among Caregivers for Persons With AD/ADRD

This 12-week trial will test the efficacy of a personalized, multi-component, personalized text-message delivered behavior change technique (BCT) intervention to encourage habitual hourly physical activity among care providers of persons with Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) via the key mechanism of behavior change (MoBC) of automaticity. The main question it aims to answer is whether a multi-component, personalized BCT intervention to increase habitual walking of \>250 steps/hour will lead to successful development of habitual hourly walking among 50% of caregivers.

Effect of Home-based Exercise Plan Mediated by Use of Digital Health App on Kinesiophobia and Functional Capacity

To evaluate the effect of home-based exercise plan mediated by a digital health application on kinesiophobia and functional capacity in sedentary post myocardial infarction patients. Evidence suggest that digital health application significantly improve physical activity level in patient following cardiac event by providing personalized exercise plan, real time feed back, progress tracking and motivational features which enhanced adherence and engagement in rehabilitation program. This study could offer a viable le solution for overcoming barrier to rehabilitation particularly for those unable to access traditional clinic-based program

Sedentary Status and Multidimensional Outcomes in Fibromyalgia

Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and functional limitations. Pain, fatigue, and fear of movement often lead individuals with FMS to adopt sedentary behaviors, which may further exacerbate symptoms and reduce physical capacity. Factors such as impaired body awareness, reduced respiratory muscle strength, kinesiophobia, central sensitization, poor functional status, and sleep disturbances play an important role in disease severity and quality of life in individuals with FMS. Although physical inactivity is common in fibromyalgia, limited evidence exists regarding the differences in these multidimensional clinical parameters between sedentary and non-sedentary individuals with FMS. Therefore, the aim of this study is to compare body awareness, respiratory muscle strength, kinesiophobia, central sensitization, functional status, and sleep quality between sedentary and non-sedentary individuals diagnosed with fibromyalgia syndrome. The findings of this study may contribute to a better understanding of the impact of sedentary behavior on clinical outcomes in fibromyalgia and help guide more comprehensive and individualized rehabilitation approaches.

Active Families, Healthy Minds: A Family-Centered School Physical Activity Program for Early Adolescents

This study evaluates the effectiveness of a family-centered school physical activity program, titled "Active Families, Healthy Minds," designed to improve mental health among early adolescents (ages 10-14) in China. In response to high academic pressure and low physical activity levels, this program integrates structured physical education sessions at school with simple, interactive home-based activity routines involving parents. The study compares this family-supported intervention against a standard school-only physical activity program and a wait-list control group. The primary goal is to determine if involving parents in school-based physical activity initiatives leads to better mental well-being, increased habitual physical activity, and stronger family support compared to school-only approaches.

Mobile Behavioral Activation Program With Wearable Sensors and Secure Activity Verification

This study evaluates a mobile-integrated behavioral activation program designed to help adults improve their daily productivity, motivation, and task engagement. The program combines a smartphone application, wearable sensor data, and a decentralized data-verification layer to support participants as they build healthier routines and increase consistent daily activity. Behavioral activation is a well-established psychological approach that encourages individuals to take small, structured actions that align with their goals and values. In this study, participants receive daily prompts, activity suggestions, and personalized behavioral tasks through a mobile app. The app uses information from a wearable sensor-such as movement patterns, activity levels, and environmental cues-to help participants track progress and stay engaged with the program. A unique feature of this study is the use of decentralized data verification. Participants' activity logs and task completions are recorded in a secure, tamper-resistant system that allows them to maintain control over their own data while ensuring accuracy and transparency. This approach supports participant autonomy and strengthens the reliability of the study's outcome measures. The study aims to understand whether combining behavioral activation with real-time sensor feedback and decentralized data verification can improve daily productivity, increase follow-through on planned tasks, and support healthier routines. Participants will use the mobile app and wearable device for the duration of the study and will complete periodic check-ins to share their experiences, challenges, and overall satisfaction with the program. The research team will evaluate changes in daily activity patterns, task completion rates, self-reported productivity, and engagement with the behavioral activation tasks. Findings from this study may help inform future digital health tools that support motivation, routine-building, and personal productivity in everyday life.

Mat Pilates on Body Awareness and Physical Activity Levels in Sedentary Emerging Adulthood Women

This study investigating the effects of mat pilates on body awareness and physical activity levels in sedentary women transitioning to adulthood, 27 control groups and 27 mat pilates exercise groups will be included. The groups will be compared at the end of an 8-week exercise program. Participants' socio-demographic characteristics, body awareness (using the Body Awareness Questionnaire), and physical activity level (using the Tegner Physical Activity Questionnaire and the International Physical Activity Questionnaire short-form scales) will be assessed.

Impact of High-Volume Upper Limb Training on Physical and Cognitive Outcomes

Engaging in regular and appropriately structured physical activities is a critical component of an individual's lifestyle and represents a lifelong habit essential for promoting overall well-being. Research increasingly emphasizes the significance of such activities, particularly in the prevention and management of various health conditions (Martin, Richardson, Weiller, \& Jackson, 2004).A sedentary lifestyle is considered one of the most serious health issues faced by individuals in the modern world.Previous research has established high-intensity interval training (HIIT) as an effective method for enhancing cardiovascular health, sparking interest in the relationship between exercise intensity and cognitive function. Most studies to date have focused on treadmill and lower extremity ergometer exercises; however, evidence regarding the efficacy of high-volume upper extremity exercises in improving physical and cognitive performance among sedentary adults remains limited and inconsistent. Upper extremity motor function has been proposed as a potential biomarker for cognitive impairment and may contribute to distinguishing healthy aging trajectories. This study aims to compare the effects of high-volume and low-volume upper extremity exercise in sedentary adults, testing the hypothesis that one exercise regimen may be superior in enhancing both physical and cognitive performance, as well as cognitive function.

The Effect of Exercise on Metabolic Alteration

The goal of this clinical trial is to study the effectiveness of aerobic exercise in treating obesity in adults and to assess the efficacy of exercise. The primary research questions it seeks to address are as follows: * To what extent does exercise increase the total energy expenditure of participants? * Why and how does the energy expenditure from exercise not fully compensate for the total energy expenditure (TEE)? * Researchers will assess the efficacy and potential challenges of using exercise as a treatment for obesity by comparing the measurement data before exercise intervention (week 0), immediately after exercise intervention (week 12), and 8 weeks post-completion of exercise intervention (week 20). Participants will engage in the following activities: * Engage in running sessions supervised five times a week for a duration of 12 weeks. * Attend laboratory sessions both before and after the exercise intervention period for metabolic and anthropometric measurements, as well as sample collection. * Return to the laboratory for further metabolic and anthropometric measurements and sample collection8 weeks post-completion of exercise intervention.

Stand & Move at Work II: Effectiveness and Implementation of a Worksite Wellness Program

This is a 2-arm group-randomized hybrid effectiveness-implementation (HEI type 2) study to test an evidence-based intervention (EBI) known as Stand \& Move at Work(SMW) to reduce sedentary time in the workplace, and to test the role of expert facilitation (SMW+) for improving intervention fidelity.

Strengthening Child Social-Emotional and Lifestyle Health in Families Experiencing Stress

This study evaluates feasibility and preliminary efficacy of a parent-based prevention program to promote social-emotional and lifestyle behavior health among 3- to 9-year-old children in families experiencing major stressors.

Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial

This study aims to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects.

Multi-organ Responses to CHronic Physical Activity and INactivity

Life expectancy has been increasing for the last 150 years, but the maintenance of health has not kept pace with increased lifespan, and on average, UK adults spend the last decade of life in poor-health, with major consequences for society and the individual. Persistent physical inactivity is thought to be a key contributing factor to the risk of poor health and functional decline occurring in middle-aged and older adults. It is therefore concerning that most middle-aged adults spend \>8hrs/day being sedentary, with average step count of 3000-4000 steps/day. To be able to holistically assess the effectiveness of future strategies to address age-related decline in health, and devise public health messages to help individuals reach older age in better health, it is essential that the complex physiological effects that activity and inactivity have across biological systems are characterised. The goal of this intervention study is to compare the impact of physical activity and inactivity on body functioning. Twenty moderately active participants will decrease their physical activity for three months to match the average amount carried out by middle-aged people in the UK. They will then undertake 3-months of reconditioning training to restore their fitness. In addition, twenty sedentary participants will increase their physical activity to UK recommended levels for six months. Before and at points during the intervention period, participants will be asked to make some measurements at home and attend the University of Nottingham to have multiple assessments made. These include; * fitness, muscle strength and function tests, * completion of questionnaires and computer-based brain puzzles * having muscle and fat tissue biopsies and blood samples taken. * The study also involves having MRI scans. This 5-year study will commence in January 2024, with participant recruitment starting in March 2024 and finishing in May 2027.

The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

The purpose of this study is to conduct a randomized controlled trial among 800 socially disadvantaged pregnant women and their families to test the effectiveness of a multi-component home visitation nutrition program, compared to usual care, in promoting healthy feeding practices, lifestyle behaviors and growth in young children.

Exploring Virtual Reality Adventure Training Exergaming

The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on women veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed to examine effects on physical and mental health outcomes.

Multiple Risk Factor Intervention Trial in Breast Cancer Survivors

This study aims to produce new evidence on the efficacy of exercise and diet for cardiometabolic risk reduction in BC survivors. Using a 3-arm RCT with to 6 months of 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions: * What is the impact of exercise on cardiometabolic health and body composition in BC survivors? * What is the effect modification of adding a diet quality intervention to exercise on cardiometabolic health and body composition? * Is there a link between the capacity of skeletal muscle adaptation to exercise (and diet) and insulin resistance in BC survivors? The investigators hypothesize that: 1) exercise will improve cardiometabolic and body composition outcomes 2) improvements in cardiometabolic outcomes will be enhanced by the addition of diet quality, which will be essential or additive for Matsuda index, metabolic syndrome, Framingham CVD risk, thigh myosteatosis, muscle mass, VO2peak, 3) skeletal muscle insulin signalling transduction will be impaired in BC survivors via dampened expression of insulin-responsive proteins (e.g. GLUT4) and co-occur with impaired muscle quality (e.g., higher rates of fat depots, presence of fibrous tissue) negatively impacting insulin signalling.

Association of a Digital Signature of Physical Activity and Sedentary Lifestyle With the Development of Multimorbidities in Chronic Diseases (eMOB)

Physical activity (PA) and sedentary lifestyle are determinants in the development of chronic diseases and associated quality of life alterations. PA levels are correlated with quality of life and morbidity in chronic lung disease (COPD), cardiovascular disease, diabetes, cancer, chronic inflammatory rheumatism, fibromyalgia and anxiety disorders. In these diseases, low-intensity PA often represents the main PA and the quantity of PA is correlated with health parameters. This study aims to identify a typical profile (signature) in relation to the appearance of other chronic diseases, complications of your disease, from recording your physical activity and sedentary lifestyle by sensors evaluating very precisely the movements and taking into account the characteristics and disability related to your disease. The results of this study would therefore make it possible to identify this signature even before the appearance of complications or other diseases.