Treatment Trials

33 Clinical Trials for Various Conditions

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RECRUITING
Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
Description

The overarching goal of this research study is to evaluate a sensor-enabled, just-in-time adaptive intervention (JITAI) strategy to increase and sustain physical activity levels among individuals with spinal cord injury (SCI) in their communities. A primary objective of this study is to evaluate the integration of a JITAI with a web-based physical activity intervention program. We hypothesize that the integration of web-based physical activity intervention program with JITAI will result in significantly higher physical activity levels compared to the standard web-based physical activity intervention program alone. A secondary objective of this study is to extend existing algorithms that use commercial wearable technology to robustly detect physical activity behaviors to facilitate the delivery of tailored just-in-time actionable feedback and physical activity recommendations for individuals with SCI.

ACTIVE_NOT_RECRUITING
Study to Learn More About the Physical Activity Level of Patients Suffering From Hemophilia A Treated With Damoctocog Alfa Pegol (LIFE ACTIVE Study)
Description

In this study researcher want to learn more about the change of physical activity of hemophilia A patients treated with damoctocog alfa pegol. Patients enrolled in this study will be wearing a small device measuring daily active time. Researcher will compare these physical activity data with patient's clinical data including bleeding events to gain information on how bleeding levels are related to the activity level of the patients. The study aims to enroll about 80 patients who are at the same time also participating in the HEM-POWR study (NCT03932201) evaluating the effectiveness and safety of damoctocog alfa pegol.

Conditions
COMPLETED
Health and Recovery Program in Increasing Physical Activity Level in Stage IA-IIIA Endometrial Cancer Survivors
Description

This randomized phase II trial studies how well a health and recovery program works in increasing physical activity level in stage IA-IIIA endometrial cancer survivors. Health and recovery program which includes exercise counseling, Fitbit tracker, and phone or email/text communication may increase the level of physical activity in endometrial cancer survivors and promote and maintain behavior change at a lower cost.

COMPLETED
A Comparison of Physical Activity Levels With and Without Feedback Via Fitbit® Flex™ in Hemodialysis Patients
Description

This is a pilot study intended to gather data in order to inform future studies about the role of feedback as an incentive for increasing levels of physical activity which could improve health in hemodialysis patients.

COMPLETED
Harvesting Health Program in Improving Diet and Physical Activity Level in Cancer Survivors
Description

This pilot clinical trial studies the Harvesting Health Program in improving the diet and physical activity level of cancer survivors. Nutrition and physical activity classes and the opportunity to harvest fruits, vegetables, and herbs may increase participants' fruit and vegetable consumption and physical activity levels. Studying the participation rates and changes in participants' eating and physical activity habits may help doctors learn whether the program has an effect on participant lifestyle.

Conditions
COMPLETED
Using Technology to Improve Physical Activity Levels Among Postmenopausal Women (The Active & Aware Study)
Description

Women who are overweight or do not exercise are at higher risk for breast cancer after menopause. This study will test a new electronic device that measures the body's movement and works alongside a website to help women increase their physical activity level. If effective, this system could be tested in larger studies aiming to reduce breast cancer risk by reducing or preventing obesity.

Conditions
COMPLETED
The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents
Description

The primary purpose of this study is to test whether rewarding physical activity with a motivational website will increase physical activity levels in middle school-aged children over six months. As a secondary outcome, the study also tests the intervention's impact on biological measures of inflammation and metabolic function in a sub-set of study participants who agree to provide blood samples.

COMPLETED
Influence of Public Parks on Physical Activity Levels of Diverse Communities
Description

Engaging in physical activity is an important health behavior for maintaining good health and preventing disease. Public parks offer community members readily accessible areas for recreation and exercise. Modifying park programs and facilities to meet the specific needs of community members may encourage people to engage in more physical activity. Furthermore, using feedback from the community might be the best way to determine how park funds should be allocated for modifications. This study will compare two approaches to park programming and will determine which approach is best at increasing physical activity within the community.

COMPLETED
Evaluation of CHAM JAM Increasing Physical Activity Levels in Students
Description

The purpose of this study is to determine if the "Moving Smart" program, a daily 10-minute classroom-based exercise program, increases physical activity levels during the school day in Bronx elementary school students.

COMPLETED
Increasing Physical Activity Levels in Low-Income Women
Description

Regular physical activity is important for good health. Women, particularly women with low incomes, have many personal barriers to regular physical activity. The purpose of this study is to reduce environmental barriers to physical activity for women in two specific low-income neighborhoods (in Louisville, KY) by providing opportunities for safe physical activity and addressing barriers such as lack of child care. Two groups of women will have pretest information (cholesterol, blood sugar, blood pressure, percent body fat, height, weight, waist and hip measurements) collected and the same information 6 months later at post-test. One group will have access to multiple physical activity opportunities in their neighborhood and at the neighborhood community center. An advanced registered nurse practitioner will facilitate the activity opportunities. The groups will be compared on their pretest and post-test information to see if the group with the physical activity opportunities has increased physical activity as measured by pedometer and self-report questionnaire, and to see if there are changes in the measures tested at pre and post (measures that may be improved by regular physical activity).

Conditions
COMPLETED
Effects of Virtual Reality Exercise on Promoting Physical Activity and Health Among College Students
Description

The purpose of this research is to examine the effectiveness of a 4-week immersive-virtual reality (VR) exercise bike intervention on college students' physiological outcomes (physical activity levels, cardiovascular fitness, and body composition) and psychological outcomes (situational motivation, situational interest, mood states, and depressive symptoms).

UNKNOWN
Wearable Sensor-based Balance Training for Patients With Knee Osteoarthritis
Description

Knee osteoarthritis (KOA) is one of the leading causes of lower limb disability among the elderly and can cause loss of knee joint proprioception that contributes towards deterioration of postural balance. Maintaining a good postural stability is essential while performing everyday functional activities and to avoid falls. Exercise training has been reported to reduce pain as well as improve performance of functional tasks in patients with KOA however compliance to exercise can be challenging due to pain, lack of motivation and traditional nature of exercise that can easily overtax patients. Furthermore, there are not exercise programs that are specifically designed for patients with KOA in order to address lost knee joint proprioception. Recent studies have also demonstrated that visual feedback during exercise can enhance the benefits of exercise training. Therefore, the aim of the proposed study is to implement an interactive sensor-based exercise training to improve postural balance, gait and activities of daily living in patients with KOA.

COMPLETED
Energy Expenditure and Physical Activity in Preschoolers
Description

The purpose of this study is to calibrate the Actigraph, Respironics and CamNtech monitors, in a wide range of children using energy expenditure measured by respiration calorimetry. Energy expenditure will be predicted from the combination of heart rate and activity measured by accelerometry. Prediction equations for energy expenditure will be tested and validated against a stable isotope method called doubly labeled water for the measurement of free-living total energy expenditure.

Conditions
COMPLETED
Web-Based Active Balance Childhood Study in Chinese-American
Description

This study compares the feasibility and efficacy of an individually tailored, child-centered, Internet-based behavioral intervention with that of general Internet-based health information for improving health behaviors and relative weight in Chinese-American children during a 6-month period. A total of 60 children (age 10-14) and their families will be randomized to either the intervention group or control group. The intervention is based on the Social Cognitive Theory and Transtheoretical Model.

Conditions
RECRUITING
ATOMIC Mobile App to Increase Physical Activity (PA) Levels in Survivors of Childhood Cancer
Description

Development and Usability Testing of the ATOMIC Mobile App to Increase Physical Activity (PA) Levels in Children, Adolescent and Young Adults (AYA) survivors of childhood cancer

RECRUITING
Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients"
Description

The main goal of this phase of the study is to determine if objectively assessed Physical Activity (PA) levels in advanced-cancer patients are associated with health care provider (HCP)-assessed ECOG performance status and overall survival. The purpose is to advance the evidence-base for incorporating objective assessment of Physical Activity (PA) in the context of performance status assessment in advanced cancer patients.

Conditions
Malignant Head and Neck NeoplasmMalignant NeoplasmMetastatic Malignant Neoplasm in the NeckMetastatic Malignant Neoplasm in the Uterine CervixPancreatic AdenocarcinomaPancreatic Neuroendocrine CarcinomaRecurrent Colorectal CarcinomaStage I Colorectal Cancer AJCC v6 and v7Stage I Hypopharyngeal Carcinoma AJCC v7Stage I Major Salivary Gland Cancer AJCC v7Stage I Nasopharyngeal Carcinoma AJCC v7Stage I Oral Cavity Cancer AJCC v6 and v7Stage I Oropharyngeal Carcinoma AJCC v6 and v7Stage II Colorectal Cancer AJCC v7Stage II Hypopharyngeal Carcinoma AJCC v6 and v7Stage II Major Salivary Gland Cancer AJCC v7Stage II Nasopharyngeal Carcinoma AJCC v7Stage II Oral Cavity Cancer AJCC v6 and v7Stage II Oropharyngeal Carcinoma AJCC v6 and v7Stage IIA Colorectal Cancer AJCC v7Stage IIB Colorectal Cancer AJCC v7Stage IIC Colorectal Cancer AJCC v7Stage III Colorectal Cancer AJCC v7Stage III Hypopharyngeal Carcinoma AJCC v7Stage III Laryngeal Cancer AJCC v6 and v7Stage III Major Salivary Gland Cancer AJCC v7Stage III Nasopharyngeal Carcinoma AJCC v7Stage III Oral Cavity Cancer AJCC v6 and v7Stage III Oropharyngeal Carcinoma AJCC v7Stage IIIA Colorectal Cancer AJCC v7Stage IIIB Colorectal Cancer AJCC v7Stage IIIC Colorectal Cancer AJCC v7Stage IV Colorectal Cancer AJCC v7Stage IVA Colorectal Cancer AJCC v7Stage IVA Hypopharyngeal Carcinoma AJCC v7Stage IVA Laryngeal Cancer AJCC v7Stage IVA Major Salivary Gland Cancer AJCC v7Stage IVA Nasopharyngeal Carcinoma AJCC v7Stage IVA Oral Cavity Cancer AJCC v6 and v7Stage IVA Oropharyngeal Carcinoma AJCC v7Stage IVB Colorectal Cancer AJCC v7Stage IVB Hypopharyngeal Carcinoma AJCC v7Stage IVB Laryngeal Cancer AJCC v7Stage IVB Major Salivary Gland Cancer AJCC v7Stage IVB Nasopharyngeal Carcinoma AJCC v7Stage IVB Oral Cavity Cancer AJCC v6 and v7Stage IVB Oropharyngeal Carcinoma AJCC v7Metastatic or Locally Unresectable Solid Tumor
RECRUITING
Testing Multi-Level Remote Physical Activity Interventions in a National Sample of Older Women: The WHISH EnCore Trial
Description

While older women are disproportionately affected by chronic diseases and conditions associated with aging, including both physical and cognitive impairments, that can be alleviated or delayed by regular physical activity, few physical activity programs have been developed specifically with their needs in mind. This research aims to evaluate, in insufficiently active older women from the national WHISH pragmatic trial, the effects of a technology-driven "citizen science" approach to environmental physical activity barriers called Our Voice plus the ongoing "light-touch" remote physical activity educational program, compared to the "light-touch" remote physical activity educational program plus a control educational intervention that creates awareness around human and planetary health. This study will add important information on the benefits and trade-offs of combining these remotely delivered and practical behavioral health approaches to promote physical and cognitive health for the fast-expanding demographic group of U.S. older women.

RECRUITING
Level of Physical Activity and Fear Learning
Description

The proposed experimental study will be the first to investigate whether exercise vs. sitting enhances consolidation of extinction learning in adults with high AS and anxiety disorders, and the mechanistic pathways of expectancy, affect, and key stress response markers.

COMPLETED
The Impact of Texas Senate Bill 42 on Middle School Children's Level of Physical Activity
Description

The purpose of this study was twofold: 1) to assess awareness of and adherence to Texas SB42 among a representative sample of public middle schools in Texas; and 2) to assess the impact of SB42 on the frequency of school PE class, the quality of school PE, and prevalence of child self-reported physical activity behaviors and child overweight along the Texas-Mexico border.

WITHDRAWN
Inpatient Physical Activity Function Through Enhanced Participation Levels in Animal-Assisted Therapy Programs
Description

Thousands of canines are used for therapy in health care centers throughout the United States as part of a volunteer therapy team, yet little is known about the outcomes provided by these teams. Although many studies have been published, few used randomized, controlled formats to identify whether canine therapy has an impact and any mechanisms by which any impact may occur. The purpose of this study is use a randomized, controlled setup for canine animal-assisted therapy (AAT) in patients undergoing inpatient physical therapy for stroke, Parkinson's disease, or generalized weakness deconditioning to determine whether use of AAT produces desirable outcomes, such as increased motivation, in patients.

COMPLETED
Feasibility of High Levels of Energy Expenditure From Physical Activity for Breast Cancer Survivors
Description

The purpose of the study is to demonstrate that breast cancer survivors who need to lose weight are able to follow a weight loss program which combines modest calorie restriction with a graduated activity program..

RECRUITING
Improving Physical Activity Participation in Latinas with Mindfulness
Description

In this study, the investigators are exploring how a mindfulness-based physical activity program can help improve exercise habits and overall health among 258 inactive Latina women aged 18 to 65. The study will be conducted entirely remotely over and 18 month period. During the first 6 months, all participants will receive an exercise program that has previously been tested by our research team. After 6 months, the investigators will check if participants are meeting the recommended exercise guidelines of at least 150 minutes/week of at least moderate intensity activity. Participants who meet the guidelines will continue with the successful exercise program for another 6 months. For participants who do not meet the guidelines (are exercising less than 150 minutes/week), they will receive one of two enhanced programs, which will be randomly assigned. One program offers additional physical activity support, and the other incorporates stress management through mindfulness techniques. For all participants, over 18 months, the investigators will track physical activity levels, stress, and heart health indicators.

COMPLETED
Effects of Peanut Butter on Sleep Quality and Daily Energy Levels in Fire Fighters
Description

The purpose of this study is to examine the possible benefits of peanut butter consumption prior to bedtime on sleep and energy levels among fire fighters. Fire fighters require high levels of energy to perform their occupational tasks but commonly lack sleep as well as the amount of dietary protein and fat suggested for tactical athletes. By addressing this gap, we expect that if peanut butter consumption is shown to improve sleep and/or energy, this lifestyle change (peanut butter consumption) may be appealing to fire fighters because of the ease and low cost of peanut butter. Aim 1: Determine if consuming peanut butter prior to bedtime alters measures of sleep quality and quantity in fire fighters. It is hypothesized that firefighters who consume the peanut butter will have positive impacts in measure of sleep quality and energy levels. Aim 2: Examine the effects of peanut butter consumption on morning and evening energy levels

ACTIVE_NOT_RECRUITING
Differences in Nutrient Use During Exercise Between Children of Varying Body Mass Indices and Fitness Levels
Description

Children who have previously participated in the study "MI Energy" will be invited to participate in "SUPER kids". Investigators want to better understand differences in nutrient use (e.g., fatty acid and carbohydrate) during rest and exercise in children of varying body types and activity levels.

Conditions
COMPLETED
Does Activity Feedback Increase ICD Patient Activity Levels?
Description

Medical device technology for use by patients is gaining popularity. Modern cardiac disease management seeks to integrate multiple device technologies and capabilities to optimize health outcomes. Fitbit, Inc. manufactures a line of wireless-enabled activity, wearable trackers that are used in conjunction with a mobile device. The Fitbit trackers use three-dimensional accelerometers to sense and record movement. This technology represents a new frontier for patients and their health care providers to understand and track physical activity in real time. The primary aim of the current project is to assess whether activity feedback using FitBit technology affects implantable cardioverter defibrillator (ICD) patient activity level as measured by the ICD accelerometer. The investigators will also examine the perceived added value of Fitbit technology to an ICD patient user experience. Approximately 50 participants will be recruited. Participants in the experimental group (n = 25) will use the Fitbit device for 12 weeks. The experimental group will receive fitness goals (number of steps per day) to increase activity from a baseline value to a minimum of 7000 steps per day by week 9 of the intervention. Both groups will receive weekly texts messages to encourage activity. Feedback about technology satisfaction, cardiac anxiety, cardiac self-care, and health care utilization will be elicited from patients at multiple time points. Additional information will be gained about patient decision-making as participants may elect to continue Fitbit use beyond the study period; this will allow for behavioral evidence of the perceived value of adding this technology.

Conditions
COMPLETED
Engaging Tribal Policy Makers to Improve the Food and Physical Activity Environments in American Indian Communities
Description

The overall objective of the study is to reduce adult obesity in participating American Indian (AI) communities and to improve understanding of the behavioral and environmental factors affecting obesity in these settings.

Conditions
COMPLETED
A Multi-level Life-span Characterization of Adult-depression and Effects of Medication and Exercise
Description

This pilot study aims to test a model that predicts that enhanced neurotransmitter gamma-aminobutyric acid (GABA) function in reward and affect-regulation central nervous system (CNS) circuits mediates the antidepressant effects of exercise. State-of-the-art magnetic resonance (MR) imaging, cognitive assessment, accelerometry, genetic, and inflammatory biomarkers will be acquired through the coordination of efforts from several established research programs at Western Psychiatric Institute and Clinic. This pilot study will be used as a platform for testing a causal/mediating role of GABA interneurons in reward processing and affect regulation in humans. This pilot study is not powered for testing a full causal model, but rather is intended to test overall feasibility of the intervention and acquisition of measures (see specific aim 1 below). This is a necessary prerequisite for designing a larger more definitive study of the model, which will be a component of a future grant application. Additionally, the data from this study will be used to test the clinical efficacy of exercise as an adjunctive treatment for late life depression (LLD; Specific Aim 2), as well as imaging, cognitive, and sleep aims (Specific Aims 3 and 4).

WITHDRAWN
LEVEL UP: Video Games for Activity in Breast Cancer Survivors
Description

The purpose of this study is to test an intervention that uses home console video games to encourage increased physical activity among postmenopausal breast cancer survivors.

COMPLETED
St. Jude Cancer Education for Children Program: Evaluation at 4th-Grade Level
Description

The main objectives of the study is to * Evaluate the knowledge acquisition and retention of 4th-grade students who participate in the St. Jude Cancer Education for Children Program * To examine the relationship between outcome measures (knowledge acquisition and knowledge retention) with covariates of interest such as self-reported age and gender * To compare the knowledge scores among schools and identify the schools that may show better improvement than others and factors associated with improvement

Conditions
COMPLETED
Impact of Move to Clinical Research Center on Physical Activity of Employees
Description

This study will examine the changes that the move from NIH's Building 10 Clinical Center (CC) into the Clinical Research Center (CRC) may have on the amount of activity a person engages in daily, as registered by a pedometer, which measures horizontal and vertical steps. The investigators in this study hope to better understand the impact that the move will have had on one group of employees compared with the impact for other groups. Moving to a new work location may require physical activity that is different from what employees currently experience on the job. In the new location, they may be walking longer or shorter distances; they may also be climbing fewer or more stairs. In addition, they may need to walk more quickly to accomplish the same tasks. It is important to understand how the move from the CC to the CRC influences employees' health, well-being, and overall function. Physical measures, such as blood pressure, will be examined. So will how well employees are adjusting to the new location-for example, through information about work-related injuries. Clinical Center employees who are able to walk, whose move dates allow 10 days in the Clinical Center before the move, who wish to participate in the study and are able to wear a pedometer, and whose work requirements include a sufficient amount of walking may be eligible for the study. Participants will undergo the following procedures before the move into the CRC and then 1 month after the move. Each evaluation will take about 30 minutes: * Brief history about age, medical problems, and current medications. * Measurements of heart rate, blood pressure, height, and weight. * Completing a brief questionnaire about the history of injuries, such as back pain, tendonitis, and bursitis. In addition, participants will complete a questionnaire about daily life and leisure activities, consisting of 94 questions, to take about 20 minutes to complete. There will also be a measurement of the distance that participants can walk in 2 minutes. A pedometer will be provided to each participant and will remain the property of that person. Participants will receive a daily log on which to record the number of steps they have walked and the distance as registered by the pedometer. About 5 minutes a day will be needed to record such information. The information that participants provide will be coded. They will not be personally identified, nor will the information be discussed with other people, including supervisors or co-workers. Information collected will be analyzed for changes in activity patterns and will be analyzed by groups of staff. For example, the investigators may wish to compare the activity of nurses before and after the move and then compare that information with information collected from food service workers, or personnel serving as messengers or escorts. Participants may find the information gathered to be useful to them as individuals. That is, they may learn that their activity has increased as a result of the move to the new location. They may have benefited by having lost weight or lowered their blood pressure.

Conditions