Treatment Trials

212 Clinical Trials for Various Conditions

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RECRUITING
NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors
Description

Pediatric cancer survivors are at an increased risk of excessive weight gain and reduced exercise behaviors with the potential for this risk to worsen over time. With over 80% of pediatric cancer patients living to adulthood, many pediatric cancer survivors experience long-term health consequences such as heart disease - the leading cause of death in this population. The purpose of this clinical research study is to teach parents/caregivers skills that will help prevent and reduce the problems of obesity in childhood cancer survivors. In this study, parents have the opportunity to participate in one of two web-based groups in which parents in either group will learn valuable information to improve the health of their child and of themselves.

COMPLETED
Assessing Exercise Behavior and Preferences Among Patients and Oncologists
Description

The purpose of this study is to understand the preferences and barriers surrounding exercise of both the patients and oncologists within Indiana University Simon Cancer Center. This information will establish gaps in our current care and provide important information to guide future pilot interventions.

COMPLETED
Understanding Mechanisms of Exercise Behavior Change
Description

This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically physical activity. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and another providing delayed rewards (i.e. rewards received at the end of the study period), with an active self-monitoring intervention condition in which no rewards are offered. Study participants will provide reports of their physical activity each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their physical activity. Following the three week reporting and reward period, participants will complete two additional assessments, measuring psychological constructs and behavior engagement following the cessation of rewards. The study will also examine how cognitive and anthropomorphic factors may contribute to intervention response and the effects on psychological constructs.

COMPLETED
A Comparison of Exercise Beliefs to Same-day Exercise Behavior
Description

Regular aerobic exercise is associated with reduced risk of multiple cancers, yet the majority of adults are inactive. Across health behavior theories, the expectations people have about the outcomes of exercise influence their decision to exercise. Extending prior work, a fine-grained analysis of the relationship between perceived outcomes and daily exercise behavior will be achieved using ecological momentary assessment methods to measure perceived outcomes, and accelerometry to measure exercise objectively. The results of this research will inform exercise promotion efforts by determining how perceptions and temporal factors interact to predict exercise behavior.

Conditions
COMPLETED
Exercise Behavior Among Young Adults Study
Description

The rate of adult obesity in the United States has increased more than two times since 1970, and the rate of child-teen obesity has increased by four times. One of the antecedents of obesity is an inactive lifestyle. Exercise has been known to be associated with increases in both physical and mental health by increasing longevity, preventing risk of obesity, coronary heart disease, and hypertension, and increasing self-esteem and overall quality of life. The broad aim of the current study is to investigate the effectiveness of psychoeducational training to increase exercise activity initiation and maintenance in young adults. The goal of this study is to compare three training approaches for college students to increase exercise behavior. One approach provides general information on the different types of exercises and benefits of engaging in exercise behavior after an initial questionnaire assessment session. A second approach includes the general exercise information and questionnaire assessment as well as training on how to create specific goal intentions (i.e., implementation intentions) to aid in exercise initiation. A third approach uses all the components of the second approach but also tests the utility of a personality-informed module by incorporating concepts from the theory of learned industriousness. It is expected that the third approach will be the most effective in helping participants initiate and maintain their exercise activities during the course of the study duration.

COMPLETED
Self-Reported Exercise Behavior and Short-Term Patient Outcomes in Women Undergoing Radiation Treatment for Operable Breast Cancer
Description

Using an observational prospective design, potential subjects will be identified and screened for eligibility via medical record review of breast cancer patients scheduled for radiation therapy at Duke Radiation Oncology Clinic. Subjects who agree to participate will be asked to complete study questionaires prior to the start of radiation therapy and again during the last week of therapy.

Conditions
COMPLETED
Mediators and Moderators of Exercise Behavior Change
Description

Rates of cancer and cardiovascular disease have shown very little improvement over the past two decades, and the incidence of Type II diabetes mellitus is increasing at an alarming rate. Recent reports estimate that approximately 30% of total cancer deaths are related to poor exercise and nutrition, and other reports have suggested that, when taking into consideration both cardiovascular disease and cancer, inactivity contributes to as many as 250,000 premature deaths per year (Booth et al., 2002). Despite the benefit of regular physical activity in the prevention of cancer and other debilitating illnesses, 75% of the U.S. population do not get the recommended amount of physical activity as defined by 30 minutes of moderate intensity physical activity 5 or more days per week (CDC, 2001), and 40% of the population is completely sedentary (USDHHS, 19960. The objective of the proposed research is to understand the mediators and moderators of a well-tested individually tailored, print-based intervention to increase exercise behavior among sedentary adults. Using a randomized, controlled intervention ton trial, the proposed study will address three primary and one secondary hypotheses: 1) A previously tested and validated exercise promotion intervention (c.f., Marcus et al., 1998) is successful at helping sedentary individuals initiate and maintain a moderate intensity physical activity regimen, as compared to a health and wellness control intervention, 2) Increases in positive attitudes, perceived normative support, self-efficacy, and intentions to exercise will mediate the effectiveness of the intervention, 3) That increased positive mood, and better temperature, stress, and lactate regulation immediately after exercise challenge (assessed in the laboratory) will moderate the effectiveness of the intervention, and 4) Secondarily, we will test whether gender, race/ethnicity, and two recently suggested genetic factors (BDNF and OPRM1) moderate the effectiveness of the intervention. The rigorous assessment of how and for whom an exercise promotion intervention is effective will provide information for future development of intervention strategies and content, as well as allow the targeting of exercise content to individuals for whom it is most likely to be effective.

COMPLETED
The Impact of Exercise Counseling on Exercise Behavior in People With Type 2 Diabetes: A Randomized Clinical Trial
Description

The purpose of this randomized clinical trial is to investigate the impact of physical therapist-directed exercise counseling combined with fitness center-based exercise training on stage of exercise behavior in people with type 2 diabetes.

COMPLETED
Interactive Technologies to Increase Exercise Behavior
Description

The purpose of this study is to examine if an individually tailored Internet intervention is more efficacious than an individually tailored print-based intervention and standard Internet intervention for physical activity adoption and maintenance among sedentary adults.

COMPLETED
Examining Psychosocial Mediators of Exercise Behavior
Description

The purpose of this study is to examine psychosocial mediators of exercise behavior.

COMPLETED
An mHealth Exercise Intervention for Sedentary Adults
Description

This pilot trial examines the feasibility and acceptability of a web-based, social networking exercise intervention in improving physical activity behavior in adults who do not perform regular exercise.

COMPLETED
Comparison of Affect-based, Self-selected, and Traditional Exercise Prescriptions
Description

This study will evaluate adherence to four types of walking programs. Participants will be randomized to walking programs that included either (1) affect-based exercise intensity, (2) self-selected (or "choice-based") exercise intensity, (3) heart-rate based exercise intensity, or (4) heart-rate guided exercise intensity with the emphasis on affective benefits.

COMPLETED
Exercise Dose-Response on Features of the Metabolic Syndrome
Description

This study investigates the degree of improvement in insulin resistance and features of the metabolic syndrome in non-diabetic overweight or obese subjects after training in a low-intensity, moderate-intensity or non-aerobic exercise program, as well as self-initiated exercise behavior after the assigned exercise program.

COMPLETED
Prostate Cancer Survivors and Exercise and Behavioral Counseling
Description

This study will evaluate the feasibility of delivering a supervised physical activity program plus standard exercise counseling (SPA+EC) versus a supervised physical activity plus motivationally-enhanced behavioral counseling (SPA+BC) in prostate cancer survivors (PCS). Fifty participants (n=25) will be randomized to receiving SPA+EC or SPA+BC (n=25). We hypothesize that PCS receiving the SPA+BC intervention will result in greater increases in objectively-assessed physical activity compared with PCS receiving the SPA+EC intervention.

COMPLETED
Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior
Description

Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, \& head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. The purpose of this investigation is to determine whether exercise based or educational based interventions are more suited for fall prevention in older adults with MS.

RECRUITING
Behavioral Exercise TRaining for Men Undergoing Androgen Depr Therapy for Prostate Ca
Description

To refine a remote behavioral exercise training intervention for testing in a larger randomized trial.

Conditions
RECRUITING
Behavioral Exercise Training to Reduce Cardiovascular Disease Risk
Description

To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance \[6MWD\]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.

COMPLETED
Exercise and Behavioral Therapy Trial (EBT).
Description

This trial is a study of Gulf War era veterans who have unexplained chronic medical symptoms such as pain, fatigue, and/or cognitive difficulties. The treatments to be studied, cognitive behavior therapy (CBT) and aerobic exercise, have been shown to be effective in alleviating symptoms in individuals with other similar types of illnesses, such as chronic fatigue syndrome and fibromyalgia. This is a Phase 3, 2X2 factorial designed study. All study participants are assigned to one of four treatment groups - CBT and aerobic exercise, aerobic exercise alone, CBT alone or usual and customary care. This study durations is 28 months; 1092 participants were enrolled and will be followed in clinic at 3, 6 and 12 months after enrollment.

COMPLETED
Translational Health After School Program on Health-Related Knowledge/Behaviors and Exercise Perception
Description

The aim of this study is to examine the effects of a translational health in nutrition and kinesiology (THINK) after school program on physical variables, nutrition and exercise knowledge base/behaviors, and exercise enjoyment and confidence. Partnering with the YMCA investigators in the Kinesiology and Sport Sciences department at the University of Miami will set up the after-school THINK program offered three afternoons per week for nine months in two experimental and two control schools. The schools will consist of minority elementary school students (predominantly Hispanic and Black) in the South Florida area. The control schools will receive baseline, mid-year and follow-up testing nine months later, but will not go through the THINK program. They will instead go through their standard YMCA after school Sports, Play, and Active Recreation for Kids (SPARK) program.

COMPLETED
Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges
Description

The purpose of this study is to examine whether an exergaming, aerobic physical education (PE) curriculum is acceptable and elicits improvements in behavioral self-regulation and classroom functioning among children with behavioral health challenges attending a therapeutic day school. After following an approved consent/assent process, children attending the school were randomized by classroom to take part in either 7 weeks of the experimental PE curriculum, or 7 weeks of the standard PE curriculum; after a 10 week washout period, children then crossed over into the other arm.

COMPLETED
Behavior and Exercise Versus Drug Treatment in Men With Nocturia (BEDTiMe)
Description

Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom. Treatment with an alpha-adrenergic antagonist medication (α-blockers) is a standard therapy for LUTS in men, but α-blockers offer only limited reductions in nocturia. While combinations of multiple drugs could be used, many individuals wish to take fewer medications. Participants in the BEDTiMe Nocturia Study will undergo a series of visits during which they will receive a combination of either standard drug therapy (or placebo) and a behavioral intervention tailored to help with nocturia or problems with nocturia. Participants will be evaluated for outcomes at 12 weeks and followed for six months. This study will yield important information related to alternative treatments of nocturia in men, as well as novel information regarding the clinical importance of these nocturia reductions. This study has the potential to alter standards of care.

Conditions
UNKNOWN
Prosocial Behavior and Exercise Among Older Adults
Description

The purpose of this study is to compare two exercise programs to determine how well they help older adults make exercise a regular habit after 9 months.

COMPLETED
Measuring Pharyngeal Muscle Improvements Following Behavioral Swallowing Exercises
Description

The purpose of this study is to learn more about how exercise and protein supply affect swallow muscles. Twenty healthy older adults will be recruited from local community centers, physician offices, and retirement communities via flyers. Participants will complete 16 sessions of standard of care swallowing exercises 2 times per week for 8 weeks. All sessions will be conducted via Zoom. During each session, a series of swallow exercises will be performed following a demonstration from a trained speech-language pathologist. Participants will be referred to NYU Langone Health or White Plains Hospital, for a videofluoroscopic swallowing study, acoustic pharyngometry and measures of hand grip strength before and after the treatment protocol. Patients will be able to select their preferred site for swallow study completion. Results will inform the relationship between swallow exercises and pharyngeal muscles. All devices and exercises are established as safe and effective and are FDA approved.

Conditions
ACTIVE_NOT_RECRUITING
A Pragmatic Trial to Determine the Benefit of Behaviorally Enhanced Exercise Incentives and Corticosteroid Injections in Osteoarthritis of the Knee Marching On for Veterans With Osteoarthritis of the Knee
Description

Knee osteoarthritis (KOA) is one of the most common and disabling conditions among Veterans. Management of KOA is challenging as there are few effective treatments other than joint replacement. Importantly, low levels of physical activity in patients with knee problems might worsen pain and disability. This study aims to determine the feasibility of using methods to change behavior that use social incentives and promote physical activity through playing games and interacting with a web-based platform. The study will also evaluate an important and widely used treatment, namely corticosteroid injections. Participants will be randomized into one of 4 arms and will receive a different combination of social incentives and injections. The study will evaluate which approach is most effective at promoting physical activity and reducing pain and disability.

COMPLETED
Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment
Description

This clinical trial evaluates the tolerability of a physical activity program in head and neck cancer patients who are undergoing cancer treatment. The goal of this trial is to give patients exercises prescribed by a physical therapist that they are able to complete regularly at home. Increasing physical activity may help patients reduce fatigue, improve mood, increase physical performance, and decrease joint pain.

COMPLETED
Group-Mediated Cognitive Behavioral Resistance Exercise Intervention in Head and Neck Cancer Patients Undergoing Chemoradiation Treatment
Description

This clinical trial examines a group-mediated cognitive behavioral resistance exercise intervention in head and neck cancer patients who are undergoing chemoradiation treatment. Chemoradiation is the established standard of care for locally advanced head and neck cancer patients. However, many head and neck cancer patients experience clinically meaningful declines in muscle mass, physical function, and quality of life during and following treatment. Resistance exercise has been shown to improve muscle mass, body composition, and physical function when integrated with appropriate standard of care nutritional counseling/supplementation. This trial may help researchers determine the important of integrating exercise interventions with routine cancer care.

COMPLETED
Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
Description

Major depressive disorder (MDD) is the leading cause of disability in the developed world and is associated with lost productivity, increased health care utilization, and mortality. Several empirically supported treatments, such as antidepressant medication and cognitive behavioral therapy, exist for the treatment of MDD; however, studies have shown that as many as 34% of individuals do not respond to these treatments. Exercise and stretching interventions represent alternative strategies associated with strong effect sizes in past studies. Additionally, exercise has been shown to enhance cognitive functioning, especially attention and memory. This study aims to investigate the effect of a combined aerobic exercise and behavioral activation treatment (BA) for MDD. Behavioral activation treatment involves completing both pleasant and mastery-based activities with the goal of enhancing mood. The current study will recruit 32 MDD patients for an active treatment phase of nine 60-90 minute sessions (6 weekly sessions and 3 biweekly sessions) of either BA plus exercise (BA+EX) or BA plus stretching (BA+STR). The purpose of this study is to identify if adding aerobic exercise to a brief psychosocial treatment can improve mood above and beyond an active control condition.

COMPLETED
Exercise as a Behavioral Treatment for Cocaine Dependence
Description

The purpose of this study is to test the effects of exercise on cocaine use, fitness, and cravings for cocaine and nicotine. This study is part of an effort to develop treatments for cocaine abuse.

COMPLETED
Effects of Aerobic Exercise Within a Behavioral Treatment Program for Chronic Headaches
Description

This proposed study seeks to examine whether adding an aerobic exercise prescription to a behavioral treatment program for chronic headaches will improve headache frequency and intensity, headache-related disability, and mood. It is hypothesized that participants who receive the exercise prescription at the start of treatment will show greater gains than those who receive the prescription halfway through treatment. It is also predicted that participants who begin the exercise component halfway through treatment will demonstrate greater improvement in the second half of treatment compared to the first half.

COMPLETED
Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)
Description

This study will evaluate the impact a behavioral intervention can have on BMI. The researchers anticipate the intervention group will experience a decrease in BMI of approximately five points. The intervention group will be compared to a control group. This is a long term, randomized, controlled study. The behavioral intervention is conducted during a four hour monthly session. The behavioral intervention includes: exercise, education on medical aspects and nutrition, and empowerment.

Conditions