Clinical Research Directory

Postpartum Exercise Intervention

The postpartum period is associated with decreases in physical activity levels, muscular strength, muscular endurance, and pelvic floor muscle function, but little scientific evidence exists on how best to initiate and progress exercise in the postpartum period. This proposal aims to improve habitual physical activity levels, neuromuscular health (i.e., strength, fatigability, symptom burden) and overall wellbeing (i.e., decreased fear of movement, improved sleep quality, improved perception of quality of life) through participation in a weekly exercise program. This study will help to inform postpartum exercise recommendations and is novel as it allows participants to incorporate their children into the exercise routine, thus removing a primary barrier to physical activity/exercise.

13-year Follow-up of Women With Chronic Low Back Pain in Primary Care - a Prospective Longitudinal Cohort Study

Background: Low back pain (LBP) is among the main causes of long-term sickness absence and is associated with considerable costs for both the individual and society. LBP affects 60-80% of the population and most individuals recover, while about 10-20% develop persistent pain and disability. Women have a higher risk of developing chronic LBP (CLBP) and widespread pain. Purpose: To investigate change in body function, activity, participation and other health related factors in women with CLBP after 13 years and to identify prognostic factors for pain, activity limitation and work ability. Methods: In the present study, all women (n = 131) who were included in the cross-sectional study in 2006 and who were followed-up after 2 years are now invited to the same study-protocol 13 years after the first examination in 2006. The Swedish Ethical Review Authority approved the study. Dnr: 2019-01944, 2019-05-21.

NEUROmuscular Training for Enhanced AGE Longevity

In recent years the research group on Prevention and Health in Exercise and Sport (PHES) has carried out numerous studies that have provided current and convincing evidence of the benefits of physical activity and exercise for chronic health, but unfortunately it has also shown that if physical exercise is not properly prescribed it can impair health, as well as accelerating the ageing process. The research proposal presented here aims to reveal some of the forms of physical exercise and resources for its application that may be most beneficial for people's health, thus trying to find reliable evidence that will increase healthy longevity and quality of life in society. Based on the above, and taking into account that the possible beneficial adaptations for health are specific to the applied form of physical exercise and the equipment used during its development, the PHES research group wishes to investigate the most appropriate strategies to ensure an active and positive ageing process. With these relevant findings the researchers can create specific action plans for prevention and promotion through physical exercise in order to improve both health and quality of life expectancy. The general objective of the project is to identify the most advanced methods and material resources with which to guarantee a beneficial process of active and healthy ageing with chronic training, so that with these relevant findings, concrete action plans can be created for prevention and promotion through physical exercise in order to improve both health and quality of life expectancy. The specific objectives are the following: * To validate new, specific, safe, and efficient tools to monitor the intensity of neuromuscular strength training activities in older adults. * To analyze and compare the chronic effects of different cardiovascular and neuromuscular strength training modalities applied with different materials on cellular ageing, body composition, metabolic, and immune profiles, cognitive function, motor function, quality of life and well-being in older adults. * To evaluate the efficacy of the use of dietary supplements to reduce or even stop the chronic adverse effects that different physical activity levels and/or physical exercise programs can have on the oxidative and inflammatory profile, body composition and metabolic profile, muscle and DNA damage, and physical performance in older adults.

Physical Activity for Myeloma Autograft Longitudinal Study

Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. Methodology and protocols are also heterogeneous. Supervised exercises program improves the physical condition and the quality of life; however there are few randomised studies versus a controlled group. Post autograft evaluation for myeloma patients showed a physical deficit with increased fat mass, but in this particular population physical exercises need to be more explored. This project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation.

Primary Care Referrals to a Remotely Delivered Physical Activity Intervention for Latina Teens: Chicas Fuertes 2

This study will test a physical activity intervention for Latina teenagers. Investigators will recruit 200 Latina adolescents who are currently under-active to participate in this 12-month study. Participants will be referred to the study by their primary care provider. Half of the participants will be randomly selected for the Intervention group, and will receive an individual counseling session and access to a personalized website. These participants will also receive a Fitbit activity tracker to help with goal setting and monitoring, plus weekly text messages and access to the study Instagram account to remind participants to be physically active. Those assigned to the control group will receive the Fitbit activity tracker.

The Efficacy of Aerobic Exercise Training on ANS and Endothelial Function in Compensated Cirrhosis

The goal of this randomized controlled trial is to investigate whether a 16-week structured aerobic exercise program combined with nutritional consultation can improve autonomic and endothelial function in patients with compensated cirrhosis. Study Design: This assessor-blinded, parallel-group randomized controlled trial will be conducted at King Chulalongkorn Memorial Hospital, Bangkok, Thailand. Fifty adults with compensated (Child-Pugh class A) cirrhosis will be recruited during routine hepatology clinic visits. Eligible participants are aged 45-75 years, have a sedentary lifestyle (\<150 minutes of moderate or \<75 minutes of vigorous physical activity per week), and have abstained from alcohol for at least six months. Exclusion criteria include active or recently treated hepatocellular carcinoma (within three months), severe portal hypertension complications (untreated large varices, prior variceal bleeding, or severe gastropathy), transjugular intrahepatic portosystemic shunt (TIPS), unstable cardiac disease, orthopedic limitations, morbid obesity (BMI \>35 kg/m²), or current use of alpha- or beta-blockers that affect autonomic function. Intervention: Participants will be randomly assigned to either the intervention or control group. Both groups will receive nutritional consultation and individualized dietary guidance at baseline, week 8, and week 16. Nutritional goals are set at 35 kcal/kg/day and 1.2 g/kg/day of protein intake. If targets are unmet, the dietitian will provide individualized recommendations to support adequate intake. The intervention group will participate in a 16-week aerobic exercise program consisting of brisk walking at moderate intensity (50-70% of maximal heart rate), totaling 150 minutes per week. The program includes two phases: * Phase 1 (Weeks 1-4): Combined hospital-based (1 session per week) and home-based exercise under physical therapist supervision, with gradual intensity titration. * Phase 2 (Weeks 5-16): Fully home-based exercise following prescribed intensity and frequency, with weekly follow-up via telephone or messaging to monitor adherence, safety, and exercise log completion. The control group will maintain their usual physical activity levels while receiving the same schedule of nutritional consultations and weekly follow-up for monitoring compliance and adverse events. Outcomes: Primary outcomes include changes in autonomic and endothelial function after 16 weeks. * Autonomic function will be assessed using the Ewing autonomic battery test (HR response to standing, deep breathing, and Valsalva maneuver; BP response to posture and sustained handgrip) and heart rate variability (HRV) indices (SDNN, RMSSD, LF/HF ratio). * Endothelial function will be evaluated using flow-mediated dilation (FMD) of the brachial artery, analyzed via Cardiovascular Suite™ software to assess nitric oxide-dependent vasodilation. Secondary outcomes include: 1. Splanchnic hemodynamics: Changes in celiac and superior mesenteric artery (SMA) blood flow measured via mesenteric Doppler ultrasound (Vivid IQ, GE Healthcare). Time-averaged mean velocity (TAMV), vessel diameter, and blood flow will be recorded at baseline and post-intervention. 2. Sarcopenia-related measures: Muscle mass (DEXA, BIA), muscle strength (handgrip dynamometry), and physical performance (6-minute walk test). 3. Laboratory outcomes: Serum ammonia, liver function tests, fasting glucose, albumin, renal function, and coagulation profile. 4. Correlative analyses: Associations between (a) muscle mass and serum ammonia, and (b) muscle mass and autonomic parameters (e.g., HRV indices).

Recovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization

The aim is to investigate the effect of early initiated and supervised mobilization continued after discharge as management of postoperative pain and recovery following obesity surgery, including patient experiences, pain coping, physical functionality and quality of life.

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, physical fitness (measured by upper body, lower body, and abdominal muscular strength), and sports participation among Chilean schoolchildren. How the study works: This study is a cluster-randomized clinical trial incorporating a control group and a pre-post design. Participating schools were allocated into two groups: Intervention Group: Participated in a specialized program focused on physical activity and the promotion of sports practice throughout two school years. Control Group: Continued with the standard school curriculum and regular physical education classes for the same period. What was measured: At baseline and after the two-year intervention, the following outcomes were assessed: Physical Activity Levels: Measured via accelerometry; Physical 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 and control groups to determine if children in the special program showed significantly greater improvements compared to those in the standard routine.

Calisthenics-Based Intervention in Adolescents: Effects on Strength, Body Composition, Eating Habits, and Self-Concept

This study evaluates the effectiveness of a school-based calisthenics intervention in promoting physical activity and improving health-related outcomes in adolescents. Physical inactivity during adolescence is a growing public health concern associated with increased risks of obesity, poor physical fitness, and reduced psychological well-being. Schools provide an optimal environment to implement structured interventions that encourage lifelong healthy habits. Calisthenics is a form of exercise that uses bodyweight movements to improve strength, flexibility, and coordination. It is cost-effective, accessible, and does not require specialized equipment, making it particularly suitable for school settings. The present study integrates a structured calisthenics program into regular physical education classes. A total of 100 students aged 13 to 16 years will be randomly assigned to either an experimental group, which will participate in the calisthenics program, or a control group, which will follow the standard physical education curriculum. The intervention will last 12 weeks, with three sessions per week. Primary and secondary outcomes will be assessed at baseline and after the intervention. These include physical fitness (muscle strength), body composition, dietary habits, and self-concept. Strength will be measured using a handgrip dynamometer, body composition through anthropometric assessment, dietary habits through a validated questionnaire, and self-concept using the Self-Concept Form-5 (AF5). Findings from this study will provide evidence regarding the feasibility and effectiveness of implementing calisthenics in school settings as a strategy to improve both physical and psychological health in adolescents.

Co-Creating Active Middle School Communities to Increase Student Physical Activity

The purpose of this study is to identify community-level barriers and facilitators for active transport and leisure physical activity and to co-create and test the effectiveness and longer-term sustainability of community-based physical activity intervention strategies in middle schools. Participation in this study may help the investigators and scientific community better understand and address child physical activity and health. This study will collect information about middle school children's physical activity behaviors, habits, knowledge, and activity. The UTHealth School of Public Health is leading the study together with the University of Texas at Austin.

Healthy Mothers-Healthy Children Nutrition

Using a randomized two-group, repeated measures experimental design, the goal of the proposed study is to investigate the efficacy of a 12-week nutrition and exercise education, physical activity, coping skills training, and home-based physical activity intervention in Hispanic women and their 3-5 year old children and 6 months of continued monthly contact to help overweight and obese Hispanic mothers improve adiposity, weight, health behaviors, and self-efficacy and their 3-5 year old children improve their adiposity and weight gain trajectory and health behaviors.

Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study

Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest. The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest. Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.

Together Everyone Achieves More (TEAM) Trial

The Together Everyone Achieve More (TEAM) Physical Activity trial evaluates the efficacy of a group-based social affiliation intervention (vs. a standard group-delivered physical activity comparison program) for increasing physical activity among inactive African American women. Using a group cohort randomized design implemented at community centers across five years, the primary aim of this study is to evaluate the efficacy of the 10-week TEAM-PA group-based intervention (vs. comparison program) on increasing daily total physical activity from baseline to post-intervention and maintenance at a 6-month follow-up.

Screen Culture's Impact on Generation Z Adolescents' Physical Activity, Posture and Well-being in Egypt

Ubiquitous adoption of screen-based technologies has transformed the behavioral and physiological environment of Generation Z youth. In Egypt, where digital adoption speeds up with apace urbanisation, teens (13-18) have greater exposure to computers, mobile phones, and other screen-based devices. Growing evidence points towards excessive viewing of screens in compromised well-being, including sleep issues, inactive lifestyles, weight loss/gain, and musculoskeletal disturbances. Contextual evidence for the Egyptian teenager is scarce. This study fills the gap by investigating the multi-dimensional influence of screen culture on physical well-being, focusing on sleep quality, body mass index (BMI), posture, physical activity, and disability outcomes.

Full-scale Intervention Study: Genetic Risk Communication and Wearables

Background: Communication of information about risk of type 2 diabetes (T2D) alone has not been associated with changes in habitual behaviors among individuals of European ancestry. In contrast, the use of wearable devices that monitor physical activity (PA) has been associated with changes in behavior in some studies. It is uncertain whether risk communication might enhance the effects of wearable devices. We aim to assess the effects on wearable-device-measured PA of communicating genetic risk for T2D alone or in combination with goal setting and activity prompts from a wearable device among overweight or obese East Asians. Methods: In a parallel group, randomized controlled trial, a total of 355 overweight or obese East Asian individuals aged 40-60 years will be allocated into one of three groups: 1 control and 2 intervention groups. Blood samples will be used for estimation of T2D genetic risk and analysis of metabolic risk markers. Genetic risk of T2D will be estimated based on 113 SNPs associated with T2D among East Asians using an established method. All three groups will receive a Fitbit device. Both intervention groups will be given T2D genetic risk estimates along with lifestyle advice, but one of the intervention groups will additionally use Fitbit's step-goal setting and prompt functions. Questionnaires and physical measurements will be administered at baseline, immediately after intervention delivery, and 6 and 12-month post-intervention following standard operating procedures. The primary outcome is time spent in moderate-to-vigorous PA measured through the Fitbit. Secondary outcomes include other parameters of wearable-device-measured PA, sedentary time, and sleep, body mass index, systolic and diastolic blood pressure, five intermediate metabolic risk markers, hand grip strength, self-reported PA, self-reported fruit and vegetable consumption and smoking status, and a list of psychological variables. Discussion: This study will be the first randomized controlled trial using the combination of communication of T2D genetic risk with standard functions of wearable devices in any population. Findings will inform strategies to prevent T2D through lifestyle modification.

Intern Health Study 2024

The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.

Effects of Polarized and Threshold Intensity Distribution Models on Race Time and Body Composition in Recreational Runners Aged 20-45 Years.

This study aims to compare the effects of two intensity distribution training (TID) models-polarized and threshold-on 5-km race time and body composition in recreational runners aged 20 to 45 years. Participants will be randomly assigned to one of two groups and will complete a 12-week structured training program. The primary outcome will be 5-km race time, while secondary outcomes will include changes in body composition. Assessments will be conducted before and after the intervention period.

Effects of Personalized Exercise Prescriptions Through Mobile Health on Physical Activity and Health Outcomes in the Cancer Survivors

Participation in regular physical activity is vital to a healthy lifestyle. Research has shown that regular participation in physical activity among cancer survivors is not only able to improve health outcomes, but is also related to their quality of life. As we live in an age of technology, health wearables and smartphone apps might be one novel manner by which to help cancer survivors increase physical activity as well as improve health outcomes. Yet, the effectiveness of wearable and app as a tool for health promotion among cancer survivors is largely unstudied. The purpose of this study is to evaluate the effectiveness of a personalized m-health intervention via fitness wearable (Fitbit Inspire 3) exercise app (sFitRx) on physical activity, weight, quality of life, individual beliefs, and emotions among cancer survivors.

Inspiring Seniors Towards Exercise Promotion to Protect Cognition

The goal of this clinical trial is to test the benefits of beat-accented music stimulation (BMS) for behavioral changes of physical activity (PA) in older adults with subjective memory complaints. Specific Aims are to determine (1) whether BMS beneficially influences PA behaviors and psychological responses to PA in older adults for 6 months, and (2) whether exercising with BMS differently influences physical and cognitive functioning as well as quality of life in older adults. To test the effects of BMS on PA, participants will be randomly assigned to an exercise intervention that either includes BMS or does not include BMS. Participants will attend a supervised group strength training (ST) (30 minutes per day) and aerobic exercise (AE) (30-50 minutes per day) session for 3 days per week for the first 2 months, 1 day per week for the next 2 months (while encouraging participants to independently perform both AE and ST on other days), and independently for the final 2 months (always with a goal of performing \>150minutes per week AE and 3 days per week of ST for 30 minutes per day).

Efficacy Trial Healthy Dads, Healthy Kids for Hispanic Fathers and Children

Hispanic men and children experience health disparities for overweight and obesity-related medical conditions, and therefore family level obesity prevention programs for Hispanic populations are needed. 'Healthy Dads Healthy Kids' is the first program to primarily target fathers for obesity prevention for themselves and their children, with significant and clinically relevant treatment effects. This is an efficacy trial to assess a culturally adapted 'Healthy Dads Healthy Kids' for Hispanic families.

Evaluating the Impact of SKY Breath Meditation on Stress, Well-being, and Connection in College Students

This pilot study will evaluate the feasibility and potential benefits of Sudarshan Kriya Yoga (SKY) for university students. Over an eight-week period, 56 students will be randomly assigned to either a SKY breathwork group or a control group engaging in general yoga without breathwork. The SKY group will participate in a three-day in-person retreat, weekly virtual sessions, and independent home practice. The study will assess recruitment, retention, and adherence, as well as changes in physical activity, perceived stress, anxiety, resilience, social connectedness, and cognitive focus. All participants will complete validated wellness questionnaires at baseline and post-intervention. The goal is to determine whether SKY is a feasible, low-risk intervention that may enhance student well-being and inform future research.

Video-Based Lifestyle Counseling in Adults With Type 2 Diabetes.

This study evaluates the effectiveness of a 3-month video-based lifestyle intervention, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with type 2 diabetes mellitus (DM2). Participants will be randomly allocated to receive the intervention either delivered by their own physician (experimental group) or by a physician unknown to them (control group). Assessment will include sociodemographic variables, glycated hemoglobin / HbA1c (primary outcome), body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the Mediterranean diet, therapeutic alliance, and health-related quality of life. The randomization process will be stratified according to HbA1c, therapeutic alliance, age, and sex.

ePlatform for Promoting Health in Schools

There are few public health and educational policies specifically aimed at promoting physical activity, healthy dietary habits, and reducing sedentary behaviour among adolescents from socially disadvantaged backgrounds. ePro-Schools will co-design, pilot and evaluate an evidence-based program, delivered via a modular eHealth platform, to promote physical activity and healthy eating, and reduce time in sedentary behaviours. A profound co-creation process involving adolescents, school staff, and policymakers-alongside the adaptation of previous interventions by consortium members-will support the program's development. The ePro-Schools platform will contain modules for adolescents and their parents, teachers and school administration. Although the platform will be implemented through schools, it will include content to be implemented outside the school setting. The intervention program will be evaluated through a randomised controlled trial conducted in six secondary schools in Central Catalonia that aims to include 1000 adolescents. Schools have been randomised (1:1) into an intervention and a waiting-list control group. The evaluation of the program includes effectiveness, cost-effectiveness and process evaluation. Physical activity, sedentary behaviour and eating habits are the primary effectiveness outcomes of the trial. Secondary outcomes include fitness, water consumption, quality of life, depressive symptoms, social isolation and sleep quality. Using implementation science methodology, ePro-Schools will co-design transferable evidence-based practices and methodologies and guidance for scaling up the platform with policymakers and stakeholders, as well as informing specialists, policymakers and the general public.

Dissemination of Physical Activity-related Health Competence in Vocational Education of Nursing Care

The "TakeCare!" study addresses the problem that vocational students of nursing care cope with great physical and psychological demands during their daily routines. To meet these demands, the Bavarian curriculum for generalist nurses has adopted the promotion of physical activity-related health competence (PAHCO) for vocational students. However, it must be assumed that the concept has not yet been adopted comprehensively across the Bavarian nursing landscape. Therefore, the "TakeCare!" study tackles the question of how PAHCO can be implemented most appropriately in Bavarian nursing schools. Drawing on experiences from the project PArC-AVE, three different dissemination approaches will being tested and compared with a control group. A total of 16 nursing schools from different regions of Bavaria will be assigned to four different study arms (cluster-randomized design). In the long term, the project aims to derive recommendations for all nursing schools in Bavaria.