Clinical Research Directory

The Validity and Reliability of the Turkish Version of the BBAQ

The Barriers to Being Active Quiz (BBAQ) was originally developed in English to identify barriers to physical activity. This study aims to translate and cross-culturally adapt the BBAQ into Turkish (BBAQ-T) and evaluate its psychometric properties.

Nurses in the Lead - Nursing Leadership and Autonomy in Function Focused Care in Hospital

The goal of this prospective before-after study (observational) is to implement Function Focused Care in Hospital (FFCiH), paying specific attention to the role of nurses and how they can take the leadership and autonomy in the interprofessional collaboration regarding FFCiH. To reach this aim, the researchers defined two sub-objectives: 1\. to identify barriers and facilitators (determinants) for nursing autonomy and leadership and application FFCiH in the interprofessional collaboration on a surgical and internal medicine ward to design a tailored implementation strategy for FFCiH. 2. to evaluate the effectiveness of the implementation strategy on nursing leadership and the application of FFCiH. The investigators developed two work packages related to the two sub-objectives: identifying determinants and strategies for the successful application of FFCiH and nurse leadership, among others, by introducing nurse champions and evaluating their effect on the application of FFCiH. The primary endpoint is the level of application of FFCiH as reflected in adherence to and coverage of FFCiH in daily nursing care. The secondary endpoints are: 1) for nurses: the nurses' role development with regards to leadership and autonomy in the application of FFCiH by ward nurses and nurse champions, leadership competencies of ward nurses, and autonomy of ward nurses and 2) for patients: physical functioning and independency in mobility and ADL. Researchers will compare FFCiH with usual care to see if there are differences regarding the outcome measurements. The study population consists of nurses, physiotherapists, doctors, other member of the interprofessional team, hospitalized patients and their relatives. Intervention: FFCiH focuses on stimulating nurses to promote patients' self-reliance in daily functioning, encouraging the patients' engagement in daily activities and, helping patients to attain and maintain their highest level of function and increasing time spent in physical activity. FFCiH is a proven effective approach for promoting patients' physical functioning and mobility.

The ALIVE-Project: Activity, Life Satisfaction, Inclusion, Vitality, Elderly Women

Many older women live alone and may experience loneliness, reduced social participation, and declining physical health. Regular physical activity can improve health and independence, but it is not known whether exercising in a supervised group setting provides additional social and psychological benefits compared with exercising independently. The ALIVE study is a 16-week randomized controlled trial that will investigate the effects of fitness club participation on loneliness, social connectedness, quality of life, mental health, physical activity, and physical fitness in women aged 75 years and older who live alone and are insufficiently physically active. Participants will be randomly assigned to one of three groups: (1) supervised group exercise at a fitness club combined with opportunities for social interaction, (2) fitness club membership with independent exercise, or (3) a control group continuing their usual daily activities. A total of 213 women will be recruited from Oslo, Norway. Outcomes will be assessed before and after the intervention using questionnaires, physical performance tests, body composition measurements, cardiovascular risk assessments, and device-based measurement of physical activity. In addition, qualitative interviews will be conducted to explore participants' experiences, barriers, facilitators, and perceptions of social connection and belonging. The study aims to determine whether supervised group exercise in fitness clubs can reduce loneliness and improve health and well-being among older women, while generating knowledge about practical community-based strategies to support healthy and socially connected ageing.

Neuro-modulation of Central Pain Pathways in Non Inflammatory Musculoskeletal Pain Syndrome

The aim of this clinical trial is to see if transcranial electrical stimulation (tES) can help reduce pain and improve quality of life in children and adolescents (ages 10-21, both sexes) with juvenile fibromyalgia or other non-inflammatory musculoskeletal pain syndromes. The main questions are whether active tES works better than sham (placebo) stimulation for pain relief and whether it leads to measurable changes in brain activity.Participants will be randomly assigned to receive either active or sham tES for 20 minutes a day over two weeks. They'll complete questionnaires about their pain and quality of life, do some simple physical and motor tests, and undergo non-invasive brain measurements before and after the intervention. The results will help understand if tES is a safe and effective option for managing chronic pain in young people. Specific Aims: Aim 1a. transcranial stimulation will be associated with significant improvements in pain and functioning (e.g., 30% or greater symptom relief or 20% or greater improvement in QoL) Aim 1b. For each tES condition, estimate mean changes in motor evoked potential (MEP) amplitudes induced by TMS stimulation. Aim 2. Compare the tES conditions (Active, Sham) in terms of the mean changes in MEP amplitude. Aim 3. Obtain statistical estimates of variance components needed for the planning of a future study. Therefore, we hypothesize that anodal tES stimulation decreases MEP amplitudes compared to sham tES condition. We further hypothesize that MEP amplitudes are positively correlated. This study will be the first randomized, double-blind, controlled study of tES technology in children as an adjunctive pain management strategy for MPS. Data from this trial will likely yield information regarding the feasibility and efficacy of tES as a chronic pain-management approach.

Effects of a School-Based Physical Activity Intervention on 24-Hour Movement Behaviours and Motor Development in Preschool Children - Study Protocol

This protocol describes a quasi-experimental controlled study evaluating the effects of the Super Quinas in Preschool programme on 24-hour movement behaviours and motor development in preschool children aged 3-6 years. The intervention consists of one additional structured 60-minute physical activity session per week for 12 weeks, delivered by a qualified exercise professional in a public preschool in Maia, Portugal. Four classes (\~80 children) are allocated at the class level: two to the intervention condition and two to the control condition (usual curricular Physical Education). Baseline data collection (T0) was conducted between 4 and 18 March 2026; the intervention commenced on 25 March 2026. Subsequent assessments are planned for early May (T1, mid-intervention), end of June (T2, post-intervention), and mid-September 2026 (T3, follow-up). Primary outcomes are 24-hour movement behaviours (ActiGraph GT3X accelerometry) and motor competence and physical fitness (Motor Competence Assessment + PREFIT subtests). Secondary outcomes include executive function (HTKS; Day-Night Stroop) and socioemotional regulation (SDQ). Statistical analyses will use longitudinal linear mixed-effects models under an intention-to-treat framework.

Factorial Trial Testing Guided Thinking Tasks to Optimize a Physical Activity Intervention

The objective of this study is to optimize a novel, audio-recorded physical activity intervention that is scalable. Using principles of the Multiphase Optimization Strategy (MOST) framework, a full factorial study will test the unique and combined effects of different intervention components to identify which combination of components is optimal for increasing physical activity and mechanisms by which the components are or are not effective. This information will inform decisions about an optimal intervention package that is effective, efficient, and minimizes participant burden.

Braining - Physical Exercise in Psychiatry - Evaluation of Feasibility, Implementation and Health Among Staff

Physical exercise (PE) shows beneficial effects on somatic and psychiatric symptoms. "Braining" is a clinical invention where psychiatric staff exercise together with patients to help patients start and execute PE regularly. In the present study feasibility of the intervention will be evaluated, how Braining is perceived and implemented, and effects on health and physical activity among staff. It is hypothesized that staff health and physical activity will increase after implementing Braining at the unit. Braining will be implemented at four psychiatric units in Region Stockholm, Sweden. During 6 months staff will be trained and receive implementation support. To measure feasibility the staff will answer self-rating questionnaires and be invited to a focus group interview post the implementation period. Implementation will be evaluated by ratings of compliance, the self-rating questionnaire Normalization Process Theory Measure (S-NoMAD), and focus group interviews. Health will be measured by self ratings of stress, sleep, general health, and engagement pre implementation and every month during the 6 month implementation phase. Ratings will be repeated at follow up 12 month after implementation started. Physical activity will be rated during the 6 months implementation phase using a tracker of activity and at follow up 12 month after implementation started. All staff at the units will be invited to participate in the evaluations, approximately 20 individuals per unit.

PA Moves Trial - Patient Participants

The purpose of this study is to address physical inactivity in rural populations in Pennsylvania.

High-Intensity Interval Training and Monocyte Epigenetic Adaptation After Detraining

This randomized, work-matched training-detraining-rechallenge study evaluated whether repeated high-intensity interval training produces persistent functional and epigenetic adaptations in human monocytes. Eighty healthy physically inactive adults aged 18-30 years were randomly assigned in a 2:2:1 ratio to high-intensity interval training (HIIT), moderate-intensity continuous training (MCT), or a non-training control group. HIIT and MCT completed 6 weeks of supervised cycling training matched for external mechanical work, followed by 4 weeks without prescribed structured training. All groups subsequently completed a standardized 30-minute cycling rechallenge. The primary outcome was the between-group difference in change in ex-vivo LPS-stimulated TNF-alpha release from baseline to the post-detraining assessment. Secondary outcomes included IL-6 release, H3K18 lactylation, monocyte subset distribution, blood lactate exposure, chromatin accessibility, H3K18la CUT\&Tag occupancy, and RNA-seq transcriptional profiling.

Supporting Physical Literacy at School and Home

The goal of this clinical trial is to test if a multilevel (school, home) physical activity intervention for school-aged (3rd-5th grade) children can increase physical activity levels. The main question\[s\] it aims to answer are: * The impact of the multilevel program on children's physical literacy and physical activity over one school year. Hypothesis: * Whether the program effects are different by children's gender or weight status * Whether changes in children's ability, confidence and motivation for physical activity are related to changes in physical activity levels. Schools will be randomly assigned to receive the multilevel intervention or a control group. Participants in the intervention group will receive a new school curriculum during regular physical education classes and information for families on what school activities can be done at home. Researchers will compare outcomes according to intervention and control group assignments.

Daily Goal Setting to Increase Everyday Physical Activity and Promote Cognitive Health in Midlife

The purpose of this study is to determine whether interaction with an adaptive Fitbit-based goal setting application can increase levels of everyday light intensity physical activity in middle-aged adults.

Testing LiverWatch, a Home-Based Remote-Monitoring Intervention for Advanced Liver Disease

Remote healthcare monitoring for cirrhosis has shown promise in overcoming barriers to accessing specialty care, improving healthcare quality, and reducing mortality. The LiverWatch study is investigating whether a remote nutrition, physical activity, and education intervention can improve health outcomes in those with cirrhosis. In this clinical trial, individuals will be randomized to either enhanced usual care or the LiverWatch intervention. Both groups are given fitbits and asked to increase their step counts. Those in the Liverwatch group will be incentivized for increase their physical activity while also undergoing a personalized nutrition intervention and weekly symptom monitoring and cirrhosis education.

YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility

Patients admitted to the hospital often develop functional impairments due to being in bed most of the day. Each day of bedrest leads to significant muscle loss. As a result, many patients become dependent on others or require rehabilitation at a facility to improve mobility and function prior to returning home. Staff in the hospital is limited and often unable to mobilize patients every day while hospitalized. The investigators are testing a new experimental gamified physical therapy exercise software to see if it can be a fun, enjoyable way to help mobilize patients without the assistance of staff. The primary aim of this pilot/proof of concept study is to determine whether gamified physical therapy software can help inpatients exercise within the safety of their own beds and preserve pre-hospitalization function.

Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults Living With HIV

The goal of this clinical trial is to examine 3 interventions designed to increase physical activity in older adults with HIV. We will examine 3 potential components of an intervention package: physical activity coaching, cognitive behavioral therapy targeted toward common barriers to physical activity such as low motivation or chronic pain, and a Fitbit-based social support intervention. Our primary outcome will be physical activity, defined as steps per day. Results will guide choice of intervention components to be used in an optimized behavioral intervention.

Online Tai Chi Plus Fitbit After ACS

This projects studies the role of tai chi exercise and wearable fitness trackers to promote physical activity in acute coronary syndrome (ACS) survivors.

Pacific Islander Physical Activity Project

This proposed longitudinal study will examine the influences of neighborhood factors and momentary contextual and psychosocial factors, which the investigators call acute precipitants, on physical activity (PA) adoption and maintenance among Pacific Islanders (PcIs). Specifically, the investigators will enroll 150 sedentary PcI adults and examine their PA adoption and maintenance based on measurements at five separate weeks during a 20-month period. The investigators will use MotionSense, an innovative and proven mHealth kit developed by team members, Global Positioning System (GPS), and ecological momentary assessment to measure PA and its key determinants. Our central hypotheses are that individual and neighborhood factors are associated with PA adoption and maintenance among previously sedentary PcIs, and that psychosocial precipitants mediate these associations.

Dyadic Physical Activity Intervention for Children Undergoing Cancer Treatment

The goal of this study is to learn if a parent-child dyadic physical activity (PA) intervention works to improve physical activity levels in children with leukaemia. It will also learn about the intervention's effects on children's self-confidence in doing physical activity and their quality of life. The main questions it aims to answer are: Does the dyadic PA intervention increase the amount of physical activity children do, compared with an individual PA intervention or usual care? Does the dyadic PA intervention improve children's confidence in doing physical activity and their overall quality of life? What is the cost-effectiveness of the dyadic intervention relative to the individual intervention and psychological support control group? Researchers will compare three groups: children and parents doing physical activity together (dyadic intervention), children doing physical activity individually (individual intervention), and children receiving psychological support sessions only (control group), to see if involving parents makes a difference. Participants will: Attend weekly sessions for 3 months (12 sessions total) Wear an activity tracker for 7 days and complete questionnaires at 5 different time points over 12 months Some participants will also be invited to take part in an interview about their experience

Motivating Activity Through Text Communications - Helping Adults Increase Movement

The goal of this clinical trial is to compare the effect of different types of text messages on physical activity levels of middle-aged and older adults and to determine whether these messages are effective in adults age 40 and older who are engaging in less than 90 minutes per week of moderate or higher intensity physical activity. The main questions it aims to answer are: * Which types of motivational messages show the greatest effects on changes in daily step counts in a 3-month precision text messaging intervention? * What are the effects of personalized text messages on automatic affective evaluations, habit strength (experienced automaticity), exercise identity, working memory capacity, and processing speed? Participants will: * Wear a Fitbit activity tracker continuously for 3 months and are encouraged to continue wearing it through 6 months. * Wear an activPAL activity monitor on their thigh for 7-day assessment periods at the beginning of the study, at 3 months, and at 6 months. * Complete 3 cognitive assessments ("brain games") per day on their smartphone during the 7-day assessment periods at baseline, 3 months, and 6 months. * Be asked to set goals to increase their daily steps over the first 3 months of the study. * Receive up to 4 motivational text messages per day for 3 months to encourage physical activity. * Keep study-related apps (Fitbit app, AIM app, MetricWire app) open in the background on their smartphone. * Complete questionnaires at the beginning of the study, at 3 months, and at 6 months

Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM

Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined. The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.

Physical Activity for PLWH and Unhealthy Drinking

Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Specifically, unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the risk of developing negative outcomes. Antiretroviral therapy (ART) has shown increasing life expectancy and decreased HIV-related deaths, leading to a growing older adult HIV population. Yet, HIV accelerates the aging process and increases the risk for numerous chronic health conditions that compromise physical and mental health functioning and quality of life. Thus, PLWH continue to have shorter life expectancies relative to the general population and these multimorbidities explain this increased risk. In this context, unhealthy alcohol use among PLWH can further increase the risk for negative outcomes. Physical activity (PA) interventions can be used as an effective way to address unhealthy alcohol use among PLWH. Previous PA interventions have shown low generalizability and high loss to follow-up. Therefore, an intervention that is home-based, including lifestyle physical activity (LPA) with mobile health-delivered components is designed following the physical activity (PA) paradigm. Participants in this randomized controlled trial will be assigned to one of two study arms -- either the LPA or Fitbit Only intervention - both lasting 12-weeks. Both study arms will utilize a Fitbit to track daily step counts. In addition to utilizing a Fitbit, the LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine. The Fitbit only arm will receive only brief check-in phone calls and only related to assisting with any Fitbit functioning issues. Follow-up assessments will take place at 3 and 6 months.

Exercise Snacking and Cardiometabolic Health

Regular physical activity is associated with numerous health benefits, yet many young adults do not achieve recommended levels of physical activity. Exercise snacking, which involves performing brief bouts of physical activity throughout the day, may provide a practical alternative to traditional exercise programs by making physical activity easier to incorporate into daily routines. This randomized controlled trial will evaluate whether a 12-week exercise snacking intervention improves physical activity levels, aerobic fitness, cardiometabolic health, and psychological well-being in insufficiently active young adults. Participants will be randomly assigned to either an exercise snacking intervention or a usual behavior control group. Assessments will be completed at baseline, after the 12-week intervention, and after an additional 12-week follow-up period to determine whether any changes are maintained after the intervention ends. The study will measure physical activity using wearable activity monitors and assess aerobic fitness, body composition, blood pressure, blood lipids, glucose, exercise motivation, affective responses to exercise, and mental well-being. The findings will help determine whether exercise snacking is an effective and sustainable strategy for improving health in young adults and may inform future physical activity recommendations and interventions

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).

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.

Effects of "Weekend Warrior" Exercise on Muscle Strength and Cardiorespiratory Finess in Sedentary Female University Students

This randomized controlled trial evaluated the effects of a weekend warrior exercise pattern on muscle strength and cardiorespiratory fitness in sedentary female university students. Forty participants were randomly assigned to either a weekend warrior group or a regular exercise group. Both groups completed 150 minutes of moderate-intensity jogging and resistance exercise per week for 8 weeks, but the weekly exercise sessions were distributed differently. Body composition, functional muscular performance, and aerobic capacity were assessed before and after the intervention.