Clinical Research Directory

Interactive Roles of Cardiorespiratory Fitness and Adiposity on Glucose and Vascular Control After Physical Inactivity

The far-reaching negative health effects of the reduced physical activity (RPA) epidemic are often overlooked by the general population and health professionals. Short-term RPA induces cardiometabolic dysfunction, including impaired glucose control and vascular function, that may precede disease development. The impact of existing health status on RPA-induced cardiometabolic dysfunction and recovery of impaired glucose control following RPA is unexplored. Thus, the investigators' objectives are 1) to investigate the effect of existing health status (cardiorespiratory fitness and adiposity) on the recovery of impaired glucose control following a period of RPA and 2) to determine the role of vascular function as a mechanism of impaired glucose control. The investigators' final objective is to 3) expose undergraduate students to meritorious biomedical clinical research methods. The investigators have piloted the clinical research methods and analysis with undergraduate researcher associates and are well-prepared to complete this proposal. Preliminary data show that low cardiorespiratory fitness and/or high adiposity impair the recovery of glucose control following short-term RPA. Thus, the investigators aim to examine the interactive role of health status (cardiorespiratory fitness and adiposity) on the ability to recover impaired glucose control following short-term RPA. The investigators also seek to examine changes in vascular function as a mechanism of recovery of impaired glucose control following a return to normal PA. The investigators will recruit men and women with divergent health status (cardiorespiratory fitness and adiposity) to examine glucose control and vascular function during 7-d of normal PA, 7-d of RPA, and 7-d of resumption of normal RA. Continuous glucose monitoring and oral glucose tolerance tests will be performed to assess glucose control. Increases in vascular shear stress induced by passive leg movement and central arterial stiffness will be measured to assess vascular function.

Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments

The goal of this clinical trial is to learn about the effect of sarcopenic status on the occurrence of treatment-related toxicity during the first course of anti-cancer treatment in several types of cancers. The main question it aims to answer is : Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment? The evaluation will focus on the body composition of the participants, assessed by impedancemetry, and on their muscular performance by standardized physical tests.

Sex Differences in Heart Rate Variability Responses to Eight Weeks of Circuit Training

The main goal of this study is to find out how an 8-week circuit training exercise program affects heart health and how the body recovers in young adults who do not regularly exercise. The researchers also want to see if these responses are different between men and women. The body's nervous system controls automatic functions like heart rate. Measuring changes in heart rate patterns-known as heart rate variability (HRV)-helps show how well the body switches between "fight-or-flight" (stress/exercise mode) and "rest-and-digest" (recovery mode). While men and women naturally have different heart rate patterns at rest, less is known about whether they recover differently after a structured exercise program. The main questions this study aims to answer are: 1. Does 8 weeks of circuit training improve heart rate recovery and nervous system balance in inactive young adults? 2. Do men and women show different heart rate responses or recovery patterns after taking part in circuit training? To answer these questions, inactive university students took part in an 8-week supervised circuit training program. Participants were considered inactive if they did less than 150 minutes of moderate exercise or less than 75 minutes of vigorous exercise per week. Participants completed 20 exercise sessions (2 times per week) led by the study team: * Exercise Sessions: Each session started with a 5-minute warm-up, followed by 10 exercise stations using light weights, resistance bands, and bodyweight movements. Exercises targeted both upper and lower body muscles. * Workouts and Rest: Participants did each exercise for 30 seconds, rested for 1 minute between stations, and rested for 5 minutes between full sets. * Progression: During Weeks 1 to 4, participants did 2 sets per session. During Weeks 5 to 8, they increased to 3 sets per session. To measure heart rate recovery, participants wore a heart rate chest monitor while resting quietly lying down: 1. Before starting the 8-week program (Baseline) 2. At 10 minutes after a workout at Week 8 (Short-term recovery) 3. At 24 hours after a workout at Week 8 (Full recovery) The researchers compared the heart rate data between men and women across these time points to see how quickly their nervous systems returned to a resting state after exercise.

Real-time Engagement for Learning to Effectively Control Type 2 Diabetes

The goal of this clinical trial is to learn if a new smartphone app that pairs glucose and exercise data will help adolescents and young adults with type 2 diabetes improve glycemic control. It will also study how changes in glycemic control are maintained over time. The main questions it aims to answer are: * Does using the app help with short-term glycemic control? * Does using the app help with longer-term glycemic control? * Does using the app help increase physical activity? Participants will: * Wear a continuous glucose monitoring device for 6 months * Wear a physical activity tracker for 6 months * Use the study smartphone app for 6 months * Complete 3 in-person study visits with fasting blood draws * Report dietary intake intermittently throughout the study

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.

Heat Therapy During Reduced Physical Activity

The purpose of this randomized controlled trial is to determine whether daily Finnish dry sauna therapy attenuates the adverse cardiovascular, muscular, and metabolic effects of seven days of experimentally reduced physical activity in healthy adults. Participants will be randomized to one of three groups: (1) maintained habitual physical activity with daily sauna therapy, (2) reduced physical activity with daily room-temperature sauna visits (control), or (3) reduced physical activity with daily sauna therapy. Reduced physical activity will be achieved by decreasing daily step count to approximately 1,000 steps per day with the assistance of a power wheelchair. Outcome measures include vascular endothelial function, exercise tolerance, muscle protein synthesis, body composition, blood pressure, glucose regulation, and physiological responses to heat exposure. The study will determine whether passive heat therapy can serve as a practical intervention to preserve cardiometabolic health during short periods of reduced mobility.

Exercise Engagement in People Over 60 at Risk of Falls

It is a qualitative study, using semi structured interviews to explore patient's experiences of falls and their perceptions on facilitators and barriers to exercise. Aim: To explore reasons for and against engaging with exercises at home in participants over the age of 60 at risk of falls. To explore: 1. Patients' preferences to exercise format and type eg/ leaflet, online, access, such as the Chartered Society of Physiotherapy (CSP) chair exercises leaflet or individual personalized rehabilitation programme handouts 2. The ability to discuss falls risk with health professionals. 3. If health inequalities exist with people at risk of falls and exercising. 4. Sustainability of exercise, in order to reduce the risk of falls in this population. 5. The need to develop MSK internal and external facing falls management pathways. Suitability: Patients over the age of 60, who have been identified at risk of falls, having been referred to MSK Physiotherapy in Rossendale. 'Risk of falls' is defined as: patient self-reports they are unsteady, had one or more fall in the last 6 months, or clinician identified a slow/unsteady gait pattern on examination. Semi structured interviews on up to ten participants. It is anticipated that this sample size will give adequate data saturation. Approximately 12 months from participant recruitment to analysis of findings.

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.

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).

Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos

The purpose of this randomized controlled trial is to assess the efficacy of Actívatexto (Aim 1) and the mediators of the presumed treatment effect (Aim 2) among Latino adults who smoke. Actívatexto is a mobile intervention that integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy \[i.e., nicotine replacement therapies (NRT)\], and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices.

Comparing Self-paced Versus Moderate Intensity Physical Activity Recommendation for Midlife Adults

We will randomly assign (blocked on Gender (female, male, other), body mass index (BMI; overweight \[25 \< BMI \< 30\]) or obese (30 \< BMI \<40) and pain status (chronic pain vs not)) adults ages 50-64 into either; (a) self-selected intensity (i.e., SELF-PACED) or (b) prescribed moderate intensity (i.e., PRESCRIBED) conditions. Prior to randomization, persons responding to our ads will participate in the following: (1) telephone screening with the study research assistant (RA) to establish eligibility; (2) an orientation session to obtain more information about the study; and, after providing informed consent (3) baseline assessment and screening (bodyweight, maximal fitness test, dietary intake, and questionnaires to assess potential covariates). Prior to randomization, the RA will give participants an accelerometer to assess baseline physical activity (PA) behavior over a one-week period. Participants will then be randomized to one of the two study conditions. Following randomization, all participants will receive our theory-based PA promotion intervention to help them overcome barriers to regular PA. All participants will be given chest strap heart rate (HR) monitors and instructions on wrist palpation. Follow-up assessments will consist of accelerometry for one-week periods at months 3, 6, 9, and 12, ecological momentary assessment (EMA) throughout the 12 months and bodyweight at 3-month intervals.

Feasibility and Acceptability of Non Weight-bearing Physical Activity for People With Diabetic Foot Ulceration

Intervention in the form of a PA (physical activity) program combining aerobic, resistance, and flexibility exercises adapted for wearing a lower limb offloading device and limiting weight-bearing on the feet, with a duration of twelve (12) weeks, consisting of two supervised sessions and one unsupervised home session per week.

Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults With Depressive Symptoms

The goal of the proposed project is to conduct a feasibility clinical trial comparing group-based acceptance and commitment therapy for physical activity, (ACT; ACTivity) to a time- and attention-matched standard PA intervention (i.e., PA education, goal-setting, and self-monitoring) plus relaxation training comparison condition (Relaxercise) among 60 low-active adults (ages 18-65) with elevated depressive symptoms. Participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment. Participants will be randomized 1:1 to treatment condition, followed for 6 months, including the 8-week treatment, and receive a 6-month YMCA membership to equate access to PA facilities.

Exercise Incentives for YMCA Based Exercise

The investigators will conduct a randomized controlled trial to test financial incentive programs (versus control) to promote physical activity among 330 adults who have a YMCA membership. Participants will have the opportunity to earn up to $100 or $200 (depending on the condition they are assigned to) for attending at least 50 sessions at the YMCA over 6 months. Participants will have two 6-month windows during which they will have the opportunity to earn the incentive. In addition to the incentives, participants will complete research assessments every 3 months.

ActivityChoice: Implementing Clinic-Based Physical Activity Program Choices for Cancer Survivors

Cardiovascular disease, the number one leading cause of death in the United States, is highly prevalent in cancer survivors. Physical activity can reduce risk, and referrals to programs addressing survivors' choices are highly recommended from providers in cancer survivorship, though rarely implemented. The study team proposes to develop ActivityChoice, a clinic-based implementation program, using patient narrative decision aids to support choices to a group in-person, group virtual, or self-monitored digital health physical activity program.

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.

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.