Clinical Research Directory

Families Moving Together Curriculum

The goal of this study is to understand how to promote physical activity among families of preschool-aged children. Participants will complete 6 weekly, in-person sessions with their 3-5 year old child that last about one hour. To evaluate this program, we will ask participants to complete: surveys before and after the 6-week program; a brief evaluation survey after each session, and a group interview that lasts about one hour after the final session. By doing this study, we hope to learn about the strategies that support and encourage families to be active together.

Feasibility of Integrating Street Racket Into Ambulatory Pulmonary Rehabilitation

This study looks at whether Street Racket is a feasable activity that can be added to pulmonary rehabilitation for people with chronic lung disease. Participants complete short questionnaires at the start and end of the program to rate the feasibility and rate their breathlessness during each session. Attendance is recorded to understand how well the activity is used and whether there are any barriers.

Impact of Digital Muscle Strength on Activity in Tech-Addicted University Students

Results from muscle strength assessment methods commonly used in physiotherapy can vary due to their lack of objective results and their reliance on the individual's muscle strength. Digital muscle testing devices provide objective results because they provide numerical data based on the resistance applied by the individual performing the measurement. These data can objectively identify weakness in specific muscles or muscle groups that may occur due to decreased physical activity levels in university students, and they will also be useful in developing an individualized exercise program.

Physical Inactivity Among Patients With Cardiovascular Risk

The goal of this clinical trial is to learn if newly developed intervention package works to improve physical activity level among patients with intermediate cardiovascular risk factors. The main questions it aims to answer are: Does the INSPIRE-PA intervention increase the level of physical activity among participants with intermediate cardiovascular risk factors? * What changes occur in physical activity level, BMI and blood pressure following participation in the intervention? * Are there any challenges, barriers, or unintended effects experienced by participants during the intervention period? * Researchers will compare the INSPIRE-PA intervention to usual care to determine whether the empowerment-based strategy is effective in improving physical activity levels and reducing cardiovascular risk among patients attending government primary medical care Iinstitutions. Participants will: * Participate in the INSPIRE-PA program for 6 months * Attend scheduled follow-up visits at the primary medical care institution (e.g., every 2-4 weeks)for counselling, evaluation of physical activity level, and assessment of cardiovascular risk indicators * Engage in structured physical activity as recommended in the intervention package * Record their daily physical activity and any challenges or barriers in a physical activity logbook or diary * Undergo periodic measurements such as blood pressure, weight, waist circumference, and other relevant clinical assessments

Seasonal Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices

The aim of this observational study is to determine the effect of seasonal changes on physical activity levels in heart failure patients with cardiac implantable electronic devices. Patients with heart failure who have a cardiac implantable electronic device will be evaluated throughout the year.

School-based Active Play Intervention to Facilitate Movement Behaviours and Fundamental Movement Skills in Primary School Children of Bangladesh

Background In Bangladesh, many children do not get enough opportunities for active play because safe play spaces are limited, school culture often prioritises academic success over physical activity, and many families have safety concerns about outdoor play. These factors reduce the time children spend being active, despite the fact that active play is known to be crucial for children's healthy growth and development. Active play helps children move more, stay physically fit, and develop important social and emotional skills such as teamwork, confidence, and enjoyment. It also supports motor skill development, which includes basic skills like running, jumping, throwing, and catching. The lack of active play in everyday life suggests a strong need for school based programs that can safely introduce regular, structured, and enjoyable physical activity opportunities for children. Objective The main objective of this study is to find out whether a school based active play program can help children increase their daily physical activity, reduce the amount of time they spend sitting, and improve their sleep patterns. The study also aims to examine whether the program improves children's fundamental movement skills, such as running, jumping, throwing, and catching. Methods This study will use a randomised controlled trial design. Randomisation will be at the school level to ensure fairness and reduce bias. This study will test a 12-week school-based AP programme designed to help primary school children in Bangladesh be more active, sit less, sleep better, and improve their basic movement skills. The study will involve eight primary schools, with each school acting as one cluster. Four schools will receive the AP programme and the remaining four will continue their usual routine. About 43 children from each school will join, giving a total sample of around 343 students. Eligibility Criteria Children can take part if they are students at a primary school, healthy, staying in their school for at least six months, able to understand basic Bengali or English, and are Bangladeshi citizens. Children will not be included if they are outside the age range, not attending school, or regularly involved in organised sports, dance, or athletic training. These rules help ensure that the programme is safe and that the comparison between the AP group and the control group is fair. Intervention Description The AP programme will run twice a week for 60 minutes. Each session will include 30 minutes of free play where children choose their own games and 30 minutes of researcher-led guided play. Activities will help children practise running, jumping, throwing, catching, and other fundamental skills. Weekly themes will keep the sessions enjoyable. Students will earn activity points for being active during sessions, reducing screen time at home, and following healthy sleep routines. Each week, the top three "Active Champions'' from every school will receive a small reward. Orientation Sessions Before the programme begins, orientation sessions will be held for parents, teachers, and children. Parents will learn how to support safe play at home, especially when outdoor play is limited due to dengue or safety concerns. They will also receive tips on reducing screen time and encouraging good sleep habits. Teachers will be trained to integrate active breaks, organise movement-friendly classrooms, use outdoor areas safely, and give feedback to students. Children will learn why active play is important and how it can help their health, learning, confidence, and friendships. Data Collection Plan Data will be collected at three time points: before the programme (T1), immediately after 12 weeks (T2), and eight weeks later (T3). Researchers will collect questionnaire responses, measure height, weight and use wrist-worn accelerometers to measure physical activity, sitting time, and sleep. Teachers and parents will help children wear the devices correctly and keep usage records. Fundamental motor skills will be assessed using the (Test of Gross Motor Development) TGMD 3 tool. Data Analysis Researchers will check all data for accuracy and compare results between the AP and control groups. The study will examine changes in PA, sedentary behaviour, sleep patterns, and FMS. It will also explore whether age, gender, or family background affects how children respond to the programme. The results will help determine whether the AP programme is practical for Bangladeshi schools and effective in improving children's movement behaviours and FMS. Expected Results It is expected that children who participate in the AP program will show clear improvements in PA levels, movement skills, sitting time, and sleep patterns compared with children in the control group. Schools may also learn simple and low-cost ways to support children's activity within limited time and space, making the program valuable beyond the study itself.

Effects of Wearable Device Functions and Health Coaching on Device-measured Movement Behaviours and Cardiometabolic Risk Factors in Adults With Central Obesity

This study is a randomized controlled trial. The objective of this study is to investigate: 1. the effects of 1-year evidence-based interventions incorporating wearable device functions alone on device-measured movement behaviours and cardiometabolic risk factors among adults with central obesity; and 2. the effects of 1-year evidence-based interventions incorporating wearable device functions combined with health coaching on device-measured movement behaviours and cardiometabolic risk factors among adults with central obesity. We hypothesise that the use of wearable device functions in combination with health coaching will lead to significantly greater improvements in device-measured movement behaviours and cardiometabolic risk factors compared with no intervention and wearable device functions alone, both after the 12-month intervention and at the 6-month follow-up. This study will implement a parallel-group, open-label, 1-year randomized controlled trial involving 133 adults aged 40 years or older with central obesity. The trial will examine the effects of a cutting-edge intervention using evidence-based wearable device functions alone or in combination with evidence-based health coaching on movement behaviours and cardiometabolic risk factors. All participants will provide written informed consent prior to participation and will be informed that they may withdraw from the study at any time during the study period. A staff member without access to participant information will generate a computer-based randomization list using permuted blocks of six, with two participants allocated to each of the three groups (two intervention groups and one control group) per block, in a 2:2:2 allocation ratio. The control group will not receive a Fitbit device and will be asked to continue their usual lifestyle. The two intervention groups will use four evidence-based Fitbit functions: step goal setting, sleep goal setting, activity prompts, and community functions. The key difference between the two intervention groups is that one group will additionally receive a structured health coaching program adapted from the U.S. Centers for Disease Control and Prevention (CDC) National Diabetes Prevention Program (NDPP), as used in our prior trial. The CDC NDPP recommends that at least 22 health coaching sessions be delivered over a 1-year period, depending on participants' needs, and provides corresponding curricula and handouts outlining session content. Coaching sessions will be delivered by trained research staff who have received appropriate professional training in health coaching delivery. The lifestyle change program will include, but not be limited to: 1. education on cardiometabolic disease risk factors (e.g., type 2 diabetes, coronary heart disease, and stroke); 2. goal planning and goal setting; 3. strategies for self-monitoring physical activity, sleep, diet, and stress; 4. strategies for initiating and maintaining favourable levels of physical activity, diet, and sleep; 5. strategies for obtaining support from family, friends, and co-workers; and 6. review of achievements and challenges during the intervention period, with goal setting and planning for the subsequent 6-month follow-up period. Participants will attend the research laboratory on three occasions: at baseline, immediately after the 12-month intervention, and at the 6-month follow-up. Assessments will include demographic information, standing height, body weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio, systolic and diastolic blood pressure, and questionnaires. At each laboratory visit, one EDTA blood sample and one clotted blood sample will be collected by a trained phlebotomist and analysed by an accredited medical diagnostic centre to assess cardiometabolic risk markers, including total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. An Axivity AX6 device will be used as a research-grade accelerometer to assess movement behaviours, including sleep, sedentary time, light physical activity, moderate-to-vigorous physical activity (MVPA), steps, energy expenditure, and resting heart rate. Participants will also be asked to wear the Axivity device on the dominant wrist for seven consecutive days at baseline and post-intervention. Research staff will access participants' Fitbit web accounts to extract Fitbit data, activate Fitbit functions for the intervention groups, and monitor device battery life. Reminders to wear and charge the Fitbit and research-grade accelerometer will be sent every seven days via WhatsApp to promote protocol compliance. To further support adherence, participants who complete all study assessments will receive a HKD 500 supermarket voucher.

We-Move With Windy: Gross Motor Development for Early Childhood

The long-term goal of this project is to learn whether a tailored physical activity program is practical, enjoyable, and helpful for families, and whether it has the potential to improve children's physical development and health. Before launching a large study, the research team completed several early phases to make sure the program met families' needs. First, a needs assessment was conducted with mothers to understand barriers to physical activity and what types of support would be most useful. Using this feedback, the program was refined and tested with three mother-child pairs over six weeks. Finally, there was an 18-week pilot randomized trial to examine feasibility and acceptability. Researchers are now conducting a larger randomized trial with up to 266 families. Half of the families are randomly assigned to receive the physical activity program, and half to a comparison group. The program combines fun, age-appropriate movement activities for children with practical support for parents. Sessions focus on building core movement skills such as jumping, balancing, running, and throwing, while also encouraging confidence, coordination, and enjoyment of being active. Activities can be adapted to each child's ability and home environment, making the program realistic for busy families. The program includes both in-person sessions and technology-based activities. In-person sessions provide hands-on support for learning new skills. Technology-based activities offer simple ideas families can use at home or during daily routines, such as hopping games, balance challenges, or quick movement breaks. Because parents in earlier phases wanted nutrition support, in-person sessions also includes a brief, child-friendly exposure to fruits and vegetables, along with simple recipes. A "Tasting Party" at the start of the program allows children to try different foods, and Veggie Meter scans at the beginning and end of the study help track changes in fruit and vegetable intake. Overall, this study will help determine whether a family-tailored physical activity program is a promising approach to improving physical activity, movement skills, and early health indicators in young children born to mothers with obesity.

Community Expecting: Exercise During Pregnancy

Regular physical activity during pregnancy is safe and offers many health benefits for both mothers and their babies. Research over the past decade shows that exercise can help pregnant women gain a healthy amount of weight, lower their risk of gestational diabetes and high blood pressure, and reduce stress, anxiety, and symptoms of postpartum depression. Babies also benefit when their mothers are active, with lower risks of preterm birth, unhealthy birth size, and childhood obesity. Despite this strong evidence, very few exercise programs for pregnant women have been tested in real-world community settings, such as fitness centers, community health programs, or local organizations. Even fewer studies explain how these programs were delivered or what helped them succeed. Without this information, it is difficult for communities and health programs to offer exercise support that is both effective and practical for pregnant women. To address this gap, the research team adapted an evidence-based program called EXPECTING so it could be delivered by community organizations. Previous participants and community advisors helped to understand what changes were needed to make the program easier to offer while still keeping it safe and effective. The core parts of the program, including the type, amount, and intensity of aerobic and strength-building exercises, remained the same and are based on established pregnancy exercise guidelines. The adapted program, called COMMUNITY EXPECTING, includes both aerobic exercise and resistance training. The research team also developed specific supports to help community instructors deliver the program consistently and with confidence. All program components have already been tested in community settings and shown to be realistic, acceptable, and delivered as planned. This study will examine whether offering a structured exercise program in community settings helps pregnant women be more physically active than usual prenatal care alone. We will also assess whether the program can be delivered successfully and in a way that works for both participants and community providers. The results will help determine whether COMMUNITY EXPECTING is a practical approach for supporting healthy pregnancies in real-world settings.

The Effect of Physical Activity on Cardiovascular Disease Risk Awareness and Self-Worth in Young Women

The main purpose of this study was to reveal the self-worth perceptions of women who regularly participate in physical activity and to investigate the effect of physical activity on self-worth perception and cardiovascular risk awareness.

Protocol for a Natural-Based Intervention to Promote Quality of Life and Healthy Habits on Children and Adolescents.

In current society, physical activity practices show a decreasing trend, together with a low perception of life quality. In addition, urban overcrowding has led to disconnection from the natural environment, causing the benefits that this context offers to be lost, especially for children and adolescents. Physical literacy is an approach to physical activity that encompasses more than just individual physical skills. It emphasises the importance of performing physical activity on a regular basis as part of daily life, encompassing bodily expression and understanding, as well as self-confidence and motivation, making it a factor that contributes to quality of life. Although research shows a correlation between physical literacy and life satisfaction, there is no research on other variables, such as the impact of green spaces in this correlation. This study aimed to present the rationale and methods of a randomized controlled trial in green spaces for children and adolescents aged 8 to 18 to evaluate the efficacy of a nature-based intervention designed to promote healthy habits through physical literacy and quality of life through life satisfaction. The statistical techniques applied will include a comprehensive method encompassing sociodemographic information, physical activity levels, perceptions of physical literacy, and life satisfaction. The camp shifts were randomly distributed, with half in the control group and the other half in the experimental group . Two measures of physical literacy and life satisfaction were measured: one at the beginning of the camp and one on the day of completion. The intervention included 24 sessions of adventure activities carried out in a natural environment, and the values obtained for both variables were collected using two questionnaires validated for these age groups. This intervention is expected to improve levels of physical literacy and perceived life satisfaction by providing valuable

An Innovative Care Model Integrating Mobile Health Support to Promote Weight Management in Adults With Overweight or Obesity

The objective of this clinical trial is to evaluate whether an innovative care model integrating mobile health (mHealth) support improves weight management in adults with overweight or obesity. The primary research questions are: (1) Does the intervention promote weight change at the 6-month follow-up? (2) Does the intervention enhance physical activity and encourage a healthy diet at the 3- and 6-month follow-ups? To address these questions, researchers will compare the intervention group with a control group to measure changes in weight, physical activity, and dietary habits. At baseline, all participants will complete a survey assessing demographics, body weight, height, central obesity, lifestyle, weight loss history, and expectations. The intervention group will receive a weight management program based on Ecological Momentary Assessment (EMA), incorporating risk-stratified health services, with follow- ups at 3 and 6 months. The control group will receive minimal intervention in the form of general health advice, with follow-ups at the same intervals.

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.