Clinical Research Directory

A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers

The goal of this clinical trial is to evaluate whether a home-based mHealth intervention can improve adherence to the 24-Hour Movement Guidelines in preschool-aged children (3-4 years old) who currently meet 0 or 1 of the guidelines for physical activity, sedentary behavior, and sleep. The main questions it aims to answer are: * Can the intervention increase the proportion of children meeting all three 24-Hour Movement Guidelines (physical activity, screen-time, and sleep)? * Is the intervention feasible for parents to implement, as measured by a parent feedback survey? Researchers will compare an intervention group to a waitlist control group to assess whether the intervention leads to increased guideline adherence. Parents and Participants: * Children will wear an accelerometer to track physical activity and sleep patterns. * Parents will use a mobile app that delivers weekly lessons and behavior-related goals to encourage healthy movement behaviors in their children. * Parents will complete questionnaires on their child's movement behaviors and development at baseline, 6 weeks, and 12 weeks. * Additionally, children will undergo motor skills assessments, and parents will provide feedback on cognitive development and behavioral changes.

E-Bike Commuting and Health in Overweight College Students

This study will evaluate the effects of using a pedal-assist electric bicycle (e-bike) for commuting on physical activity, fitness, and health in overweight or obese college students. Participants will be randomly assigned to either a 8-week e-bike commuting intervention or a control group. The study will measure changes in cardiorespiratory fitness, body composition, blood biomarkers, physical activity, and psychological well-being over a 16-week period.

StandUPTV Habits: Feasibility Trial for Maintaining Reductions in Sedentary Screen Time

Our goal in this study is to further refine StandUPTV, an application designed to reduce SST in adults in our first study (ASU IRB # STUDY00012109), for the StandUPTV Habits program. This program aims to establish a non-sedentary habit triggered by an alert from the StandUPTV application after participants engage in approximately 30 minutes of SST in the evening.

Newenkantun: a Play-based Program to Promote Socioemotional Learning in Early Childhood Education in Chile.

What is this study about? This study will test a program called "Newenkantun" (which refers to a hand-strength game in Mapuche culture) designed to help young children develop important social and emotional skills through play and physical activity. The program focuses on helping children learn how to understand and manage their emotions, get along with others, and make good decisions - skills that are important for success in school and life. Why is this study being done? The early years of childhood are a critical time for developing social, emotional, and physical skills. Many children, especially those from low-income families, face challenges that make it harder to develop these skills. This study will test whether a program that combines active play, social-emotional learning, and family involvement can help young children in the Araucanía region of Chile develop these important abilities. The program also aims to help children be more physically active, spend less time on screens, and get better sleep - all of which are important for healthy development. Who can participate? Children ages 4-6 years old (attending transition levels 1 and 2 in early childhood education) in the cities of Temuco and Padre Las Casas in the Araucanía region of Chile. Both their teachers and parents/guardians will also participate in the program. What will participants do? Children will participate in play-based activities at their schools over 16 weeks. These activities use storytelling and imaginative play (like pretending to be different characters) to help them practice social and emotional skills. The activities respect and incorporate the cultural background of the Araucanía region, including Mapuche cultural elements. Teachers will receive training and support (both in-person and online) to learn how to teach social-emotional skills and promote healthy movement behaviors in their classrooms. They will receive materials and kits to help them run play activities. Parents and guardians will receive support through an online platform, app, social media, and printed materials. They will learn about the importance of social-emotional development and healthy movement habits, and get practical tips for supporting these at home. The program includes 8 topics delivered over 4 months, with each topic taking about 30 minutes to complete. What will be measured? Researchers will measure: Children's social and emotional skills (like managing emotions, getting along with others, and making responsible decisions) Physical activity levels, screen time, and sleep patterns Motor skills and thinking abilities Teachers' confidence and practices in teaching social-emotional skills Parents' support practices at home The school environment and how well it supports these skills These measurements will happen at the beginning of the program, at the end, and at follow-up visits 3, 6, and 12 months after the program ends. How is the study designed? The study uses a "stepped-wedge" design, which means that 10 schools will start the program at different times, chosen randomly. This design allows all schools to eventually receive the program while still allowing researchers to compare results. Each school will participate for 16 weeks, and researchers will follow what happens afterwards to see if the benefits last over time. What are the potential benefits? If successful, this program could provide a practical, culturally appropriate way to help young children develop important social, emotional, and physical skills during a critical time in their development. The program is designed to be sustainable and could potentially be used in other schools and communities in the future.

Effect of Integrated Dual-Task Trunk Stabilization and Balance Training in Sedentary Adult Females

Balance and postural control are fundamental components of functional independence and quality of life in adults. Deficits in trunk stability and balance are strongly associated with increased fall risk, impaired mobility, and decreased ability to perform activities of daily living in sedentary individuals and clinical populations. Trunk muscles play a key role in stabilizing the spine and coordinating movement; their activation is essential for maintaining balance during static and dynamic tasks. Evidence suggests that targeted trunk training can significantly improve postural control and functional outcomes.

Acute Responses to Walking, Stair Climbing, and Functional Circuit Exercise

This study evaluated the acute physiological responses to three different exercise modalities in sedentary young men. Participants completed walking, stair climbing, and functional circuit exercise sessions in a randomized crossover design. Each exercise session lasted 20 minutes and was performed at a target intensity of 50% heart rate reserve (±5 beats/min), with at least 72 hours between sessions. The study compared acute respiratory, metabolic, and neuromotor responses to the three exercise modalities. Pulmonary function was assessed using spirometry, blood lactate concentration was measured using capillary blood samples, and countermovement jump performance was assessed as an indicator of neuromuscular performance. Heart rate was continuously monitored during each exercise session.

Evaluation of Choose to Move Replacement Ready (CTM-RR)

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. Recently, the investigators adapted CTM for the \>14000 people in BC who are on surgical waitlists for total knee replacement or total hip replacement (TKR/THR) for osteoarthritis (OA). The primary goals of this observational study are to describe how the adapted program, Choose to Move Replacement Ready (CTM-RR), is implemented in BC and determine if the adapted program improves health outcomes in people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. The investigators will also evaluate whether any health benefits achieved by CTM-RR participants are maintained three months after they finish the program and also during the remaining time that they wait for their TKR/THR surgery. The investigators will work with referral partners from hospitals and orthopaedic clinics in BC to recruit participants into CTM-RR. Participants who enrol in CTM-RR will answer online survey questions about the program and about their physical activity, mobility, pain, function, quality of life, willingness to undergo surgery, overall perception of their joint condition, psychosocial health, self-efficacy, social isolation, loneliness, and sedentary time. CTM-RR activity coaches will also answer online survey questions about the program. CTM-RR participants, activity coaches, and referral partners will also participate in interviews about the program.

Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study

The purpose of this research study is to explore ways to improve motor, cognitive and immune functions for aging adults using multiple techniques like lifestyle changes and risk factor management, as well as medications and supplements believed to have a positive effect on health.

Effectiveness of Health Education Program on Musculoskeletal Pain Management in Primary School Students

Musculoskeletal pain during childhood can negatively affect school attendance, physical activity, and social participation. This study will evaluate the effectiveness of the school-based health education program 'SocLaLola', which uses a comic-based narrative to introduce children to pain science concepts and promote healthy lifestyle habits. The intervention will be compared with a standard program focused on sedentary behavior prevention. Students aged 8 to 11 years from two primary schools will participate. The primary objective is to determine whether SocLaLola is more effective than the comparison program in improving children's knowledge about pain and in reducing fear-avoidance beliefs related to physical activity.

Active Schools in Chile: Impact on Fitness, Physical Activity, and Sports Participation

Study Rationale: Currently, a significant proportion of children in Chile do not meet recommended physical activity levels, which may adversely affect their health and development. The school environment provides an ideal setting to promote healthy habits. This study was designed to evaluate whether a school-based program incorporating physical activity, sports, and health education can improve physical fitness and increase the time children dedicate to physical activity practice. Objective: The primary objective of this study is to evaluate the impact of a two-year school-based intervention on physical activity levels, muscular fitness (measured by upper body, lower body, and abdominal muscular strength), and sports participation among Chilean schoolchildren. How the study works: This is a single-arm cluster intervention study incorporating a pre-post design. Participating schools were allocated in a specialized program focused on physical activity and the promotion of sports practice throughout two school years. What was measured: At baseline and after the two-year intervention, the following outcomes were assessed: Physical Activity Levels: Measured via accelerometry; Muscular Fitness: Assessed through muscular strength tests, including upper limb strength (handgrip strength using a dynamometer), lower limb strength (standing long jump test), and abdominal strength (60-second curl-up test). Sports Participation: Evaluated through self-reports of involvement in organized sports. Researchers compared pre- and post-intervention data between the intervention to determine if children in the special program showed significantly greater improvements compared to those in the standard routine.

Sedentary Activities and Passive-to-Intense Effects on Neuro-Cognitive States

Prolonged sedentary behavior is linked to poorer metabolic health, yet its effect on cognitive load and brain function remains unclear. Evidence indicates that "mentally active" sedentary tasks (e.g., reading) may support cognition, whereas "mentally passive" tasks (e.g., scrolling social media) may impair it. The cognitive demands associated with these behaviors across the general population are still poorly defined. This project will compare the acute neurophysiological and perceptual responses elicited by mentally active versus passive sedentary tasks across various age groups and in individuals with specific health conditions (i.e., obesity), clarifying how these behaviors differ in the cognitive load they impose. Neuro-cognitive, physiological, and perceptual responses will be assessed with a multimodal battery that includes portable electroencephalography combined with functional near-infrared spectroscopy (EEG + fNIRS; MUSE), eye-tracking (Pupil Core), alertness and visual fatigue via critical flicker fusion testing (CFFT; Lafayette Instrument), autonomic balance through heart-rate variability (HRV) recorded with a Polar H10 monitor, and the self-reported cognitive load assessed using the NASA Task Load Index (NASA-TLX). We hypothesise that mentally passive sedentary activities will elicit a lower cognitive load than mentally active tasks. By comparing different age groups and health conditions within a single protocol, the study will generate an initial set of group-specific data; subsequent independent studies can build on these findings to explore moderation effects in greater depth. Collectively, the results will provide both the theoretical rationale and the empirical evidence needed to sustain the "mentally active" versus "mentally passive" terminology in sedentary-behaviour research, with the ultimate aim of improving mental and cognitive health.

Effects of Exercise Snacks on Clinical and Health Outcomes

Physical inactivity and prolonged sedentary behavior are major health concerns, especially for individuals with chronic conditions such as diabetes and prediabetes. Many patients have difficulty following traditional exercise recommendations due to time constraints, limited physical capacity, comorbidities, or lack of access to exercise facilities. Therefore, new and more practical exercise strategies are needed. "Exercise Snacks" is a novel physical activity approach that involves short bouts of exercise performed multiple times throughout the day. Each session is brief and easy to integrate into daily life, such as performing short periods of resistance exercises, brisk walking, stair climbing, or other simple activities. This approach may improve exercise adherence and provide health benefits without requiring long exercise sessions. The purpose of this study is to evaluate the feasibility and acceptability of an Exercise Snacks intervention in sedentary adults with diabetes or prediabetes and to explore its potential effects on cardiovascular and metabolic health, physical function, and body composition. In this study, sedentary adults aged 18-65 years with diabetes or prediabetes will participate in a 12-week study and will be randomly assigned to either an Exercise Snacks group or a control group. Participants in the Exercise Snacks group will perform short exercise sessions lasting approximately 3-5 minutes, including simple resistance exercises and short aerobic activities. These exercise sessions will be performed several times per day and integrated into daily routines. The control group will maintain their usual lifestyle without additional exercise intervention. Participants may use wearable devices or mobile applications to receive reminders and record exercise activity. Assessments will be conducted before and after the intervention to evaluate physical activity adherence, physical function, body composition, blood pressure, blood glucose, and other cardiovascular and metabolic health indicators. This study aims to determine whether short, frequent exercise sessions are a practical and effective alternative to traditional exercise recommendations for sedentary individuals with diabetes or prediabetes. The results of this study may help develop more feasible lifestyle intervention strategies to improve long-term exercise adherence and overall health in individuals with chronic diseases.

Active Pauses for Musculoskeletal Disorder Prevention in Workers

The goal of this clinical trial is to learn if short exercise breaks at work can prevent muscle and joint pain in workers. The main questions it aims to answer are: Do strength exercises help workers move better and feel less pain? Are strength exercises better than stretching exercises for worker health? Researchers will compare a strength exercise program to a mobility (stretching) program to see which one works better to improve physical health and work ability. Participants will: Perform short exercise breaks (5 minutes) at their workplace every day for 8 weeks. Attend one supervised session per week to learn the exercises. Complete simple physical tests (like standing up from a chair) and answer surveys about their health at the start and end of the study.

"Effectiveness of Supervised and Unsupervised mHealth-based Exercise Interventions on Clinical Outcomes in Adults With Type 2 Diabetes and Obesity Within a Primary Care Context"

Type 2 diabetes (T2D) and obesity are two of the most common chronic conditions worldwide, and they frequently occur together. Both conditions are closely linked to physical inactivity, which is currently recognized as a major risk factor for a wide range of diseases. Although structured exercise programs have shown benefits for people living with these conditions, maintaining long-term participation remains a significant challenge. The rise of mobile health (mHealth) technologies - such as smartphone apps and wearable devices - offers a promising new way to support people in becoming and staying more physically active. This study aims to compare the effects of two different 20-week exercise intervention programs versus standard medical care in adults aged 30 to 65 who have been diagnosed with both T2D and obesity. Participants will be randomly assigned to one of three groups: Group 1 (Supervised Training): Participants will attend two in-person, supervised exercise sessions per week at a local sports facility, each lasting 60 minutes. Sessions will be led by a qualified trainer and will include strength, flexibility, and functional exercises. Participants will also receive weekly motivational text messages and group health coaching. Group 2 (Unsupervised mHealth Training): Participants will follow the same exercise plan independently using a mobile application (ActiVital), which is part of the Andalusian Physical Activity Prescription Plan (PAPEF). They will receive their weekly training schedule through the app and will also receive text messages and group health coaching. Group 3 (Control Group): Participants will continue with their usual medical care without any structured exercise program. All participants across the three groups will be provided with a Fitbit Charge 6 wearable device to monitor daily physical activity and health indicators. The study's central hypothesis is that both structured supervised exercise and app-guided unsupervised exercise will lead to meaningful improvements in clinical indicators - such as blood glucose levels, glycated hemoglobin (HbA1c), blood lipids, and blood pressure - as well as in body composition, physical fitness, sleep quality, and overall quality of life, when compared to standard care alone. It is also hypothesized that the mHealth approach will show particular benefits in terms of adherence, self-management, and scalability. A total of 126 participants will be recruited through the Primary Care Center of Osuna (Seville, Spain), with measurements taken before and after the 20-week intervention period. The study will help determine which type of exercise program is most effective and feasible for people managing both type 2 diabetes and obesity in a primary care setting.

Pilates for Sedentary Individuals

The global rise in physical inactivity represents an escalating public health crisis, with the proportion of insufficiently active adults projected to reach 35% by 2030. Office workers are at the highest risk due to prolonged occupational sitting; a lifestyle factor heavily linked to various musculoskeletal disorders. While maintaining an upright posture relies on the synergistic coordination of deep core muscles, extended sitting disrupts this muscular balance, leading to chronic postural decay. Although Pilates is proven to improve core muscle thickness, enhance physical fitness, and alleviate low back pain, existing literature shows high variability in training durations (ranging from 6 to 16 weeks) and lacks definitive conclusions regarding its long-term, residual effects post-intervention. Consequently, it remains unclear whether the benefits of Pilates can be sustained once the structured training stops. Therefore, this study aimed to investigate the efficacy of Pilates on core stability and physical fitness among sedentary individuals, providing insights into sustainable exercise interventions.

The Women Veteran's Health Mission

The purpose of this study is to evaluate the impact of a customized web-based e-health program to provide online health promotion (Missions), peer support, and social connectivity to women Veterans and their families. Primary Objective • To assess participant engagement in the program including: completion rates (%) for each 6-12 week health program (Mission) defined as completing the assessments following the intervention number of login days among those who register and drop-out rates (%) defined as those who start but do not complete the program. Secondary Objectives • To assess the impact of a web-based wellness program on health metrics including: change in body weight (lbs) sleep, and chronic pain (PROMIS 29 Questionnaire) stress (PROMIS Perceived Stress) social isolation (PROMIS Social Isolation Short Form 4a). • To determine whether there is a dose-response between the number of login days into the program and changes in health metrics.

Physical Activity in Persons With Parkinson's Disease

This project aims to identify why some people with Parkinson's disease (PwPD) become less physically active, and which factors support or hinder activity. Understanding these factors is essential for developing person centred interventions and effective support that can be implemented in routine healthcare. A national, multicentre longitudinal cohort study will be conducted including approx 450 PwPD from five Swedish regions (including the internal pilot NCT06901869). Physical activity will be measured objectively with activity monitors, combined with clinical assessments and digital questionnaires over four years. The primary outcome is physical activity level (accelerometer measured decline), and exposure variables include physical, cognitive, disease specific, social, environmental, motivational, and personal factors. Data collection involves clinical tests, questionnaires, accelerometer data, and patient reported experiences. This is a continuation of an internal pilot study NCT06901869. The study will enable early identification of those at risk for declining activity and guide development of person centred, evidence based interventions. Long term, it aims to integrate activity monitoring and risk factor screening into routine care to improve health and quality of life for PwPD.

Step-Up vs. Running Exercise at Matched Heart Rate Zones in Sedentary Males

This study compares the effects of two aerobic exercise methods - loaded step-up exercise and treadmill running - on cardiovascular fitness, leg strength, heart rate variability, and recovery in sedentary adult males. Both exercise groups will train at 80-85% of maximum heart rate, three sessions per week for six weeks. A control group will not participate in any training. Measurements of estimated VO₂max, isometric leg strength, resting heart rate, heart rate variability indices, and heart rate recovery will be taken before and after the intervention.

Effects of Virtual Reality and Traditional Exercise on Cognitive and Physical Performance in Sedentary Adults

This study aimed to compare the effects of virtual reality (VR)-based exercise and traditional exercise methods on selected physiological and cognitive parameters in sedentary individuals. Sedentary lifestyles are increasingly associated with reduced physical fitness and impaired cognitive performance, including decreased concentration, slower reaction time, and reduced flexibility. While traditional exercise programs are effective, their long-term adherence may be limited due to low motivation. Virtual reality-based exercise has emerged as an innovative approach that combines physical activity with interactive and engaging environments, potentially enhancing both motivation and cognitive engagement. Therefore, this study investigated whether VR-based exercise provides additional benefits compared to traditional exercise. A total of 33 sedentary adults were randomly assigned to three groups: a VR exercise group, a traditional exercise group, and a control group. The intervention groups participated in structured exercise programs three times per week for eight weeks, while the control group maintained their usual lifestyle without exercise intervention. Outcome measures included concentration, reaction time (hand and foot), balance, and flexibility, assessed before and after the intervention. The findings of this study are expected to contribute to understanding whether VR-based exercise can be used as an effective alternative to traditional exercise methods for improving both cognitive and physical performance in sedentary populations.

High-Intensity Exercise Snacks for Reducing Mobile Phone Addiction in Adolescents

This study is a randomized controlled trial (RCT) designed to evaluate the long-term effectiveness of "Exercise Snacks" (fragmented, high-intensity bouts of exercise) in reducing mobile phone addiction among adolescents. Participants will be randomly assigned to either an intervention group or a control group. The intervention spans 5 months and is followed by a 1-month follow-up period (Month 6). The intervention group will perform short bursts of exercise (e.g., 1-minute sprints, squats) multiple times daily during school breaks. The program is divided into three progressive phases: adaptation, enhancement, and consolidation. The study aims to determine whether this sustained "snack-style" exercise regimen can significantly lower mobile phone addiction scores, improve physical fitness, and enhance psychological traits such as self-control and resilience over a semester-long period.

Floor Sitting Study

The goal of this clinical trial is to evaluate the impact of different sitting environments on general well-being and movement patterns in healthy young adults aged 18-35. The main questions it aims to answer are: Does floor sitting lead to increased movement and postural changes compared to chair sitting? Over a month-long period, how does sustained floor sitting influence overall well-being, posture, and movement habits? Researchers will compare the effects of chair sitting and floor sitting in a controlled lab environment (Aim 1) and observe the longer-term effects of habitual floor sitting in participants natural environments (Aim 2) to see if consistent floor sitting promotes more dynamic movement and comfort. Participants will: Undergo two 30-minute experimental sitting sessions, one in a chair and the other on the floor, while engaging in typical desk activities (Aim 1). Participate in a month-long study where they integrate an hour of floor sitting into their daily routines, recording their experiences and any changes in sitting habits through daily diaries and in-depth interview (Aim 2).

MAFF-CRT: Reducing Sedentary Behaviour in Children

Children today spend many hours sitting at school and at home, often in front of screens. Prolonged sitting in childhood increases the risk of future health problems such as diabetes, heart disease and poor mental wellbeing. MAFF is a simple school-to-home programme that teaches short, practical movement breaks in the classroom and encourages families to repeat them together at home through structured weekly challenges. Over 12 weeks, we will compare classes using MAFF with classes continuing as usual to assess whether children sit less, move more and improve their wellbeing. If effective, MAFF will provide schools and communities with an easy-to-implement toolkit to promote healthier and more active families.

Changes in 24-hour Activity Cycle Behaviors During a Time-Restricted Eating Intervention in College-Aged Women

Time-restricted Eating (TRE) is a dietary approach that limits food intake to 4 - 12-hour windows without intentionally altering diet quality. TRE has several benefits including modest reductions in body weight and fat mass, improved glucose control, and reduced inflammatory markers. While research supports the metabolic and weight related benefits of TRE, there is limited evidence of its effects on physical activity (PA), sedentary behavior (SB) and sleep - the core components of 24-hour Activity Cycle (24-HAC), which is a holistic framework that integrates the three health-related activities. TRE research has largely focused on clinical populations, leaving its feasibility and adherence in healthy younger adults understudied. Within this group, college students' misaligned circadian rhythms and unpredictable schedules may make adherence to TRE challenging, highlighting the need for research on its practicality in this group. These outcomes are also particularly important to investigate in women, considering that SB is more prevalent among college-aged women (69%) compared to men (46%). To address these issues, we will conduct a three-week intervention to study the effects of TRE on the 24-HAC outcomes. College aged women will be screened and enrolled, then assigned to either a control or TRE group. Participants in the TRE group will self-select the timing of their 8-hour eating window which they will maintain throughout the study (with compliance on at least six days per week needed to be considered adherent). The control group will receive a basic nutrition education at the start of the study and will have no restriction on eating times. 24 HAC behaviors will be measured continuously for one-week of baseline measurement and throughout the intervention by wrist-worn ActiGraph GT9X monitors. Participants will also record the timing of their first and last meal each day and receive periodic reminders to report their hunger and satiety ratings using visual analog scales.

Feasibility of Choose to Move Replacement Ready

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. Recently, the investigators adapted CTM for the \>14000 people in BC who are on surgical waitlists for total knee replacement or total hip replacement (TKR/THR) for osteoarthritis (OA). The primary goal of this observational study is to learn if the adapted program, Choose to Move Replacement Ready (CTM-RR), is feasible to deliver to people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. Participants who enrol in CTM-RR will answer online survey questions about the program and about their physical activity, mobility, pain, function, quality of life, willingness to undergo surgery, overall perception of their joint condition, psychosocial health, self-efficacy, social isolation, loneliness, and sedentary time. CTM-RR activity coaches will also answer online survey questions about the program. CTM-RR participants, activity coaches, and referral partners will also participate in interviews about the program.