26 Clinical Trials for Various Conditions
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 min/day) and and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/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 \>150min/week AE and 3 days/week of ST for 30 min/day).
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. 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 min/day) and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/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 \>150min/week AE and 3 days/week of ST for 30 min/day.
The goal of this clinical trial is to test the effect of an affect-based exercise prescription on moderate-vigorous physical activity participation among survivors of breast cancer who completed primary treatment within the last 5 years. The main questions it aims to answer are: 1. Do at least 50% of participants assigned to the affect-based exercise prescription engage in ≥90 minutes of moderate-vigorous physical activity by the end of 12-weeks follow-up? 2. What level of satisfaction do breast cancer survivors who receive the affect-based exercise prescription report relative to breast cancer survivors who receive an effort-based exercise prescription. 3. What proportion of participants assigned to the affect-based exercise prescription stay enrolled in the study relative to the number of participants who stay enrolled in the effort-based exercise prescription. All participants will: * Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription. * Participate in two meetings with a member of the study team meant to help them get started increasing weekly exercise. These meetings are the same for all participants. * Be asked to wear an activity monitor and respond to brief surveys for 10 straight days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.
The purpose of this randomized controlled trial is to evaluate whether the InMotion intervention, delivered via telehealth (using a HIPAA-compliant video platform or phone), which uses evidence-based behavioral and motivational counseling to increase daily physical activity, is an effective treatment for Major Depressive Disorder (MDD) for people who are at least one year out from sustaining a traumatic brain injury (TBI). The first aim is to compare the efficacy of the InMotion intervention to the waitlist control (WLC) condition on measures of depression severity and associated conditions in under-active adults with TBI and MDD. For the second aim the investigators plan to identify possible moderators of exercise treatment effects. The third aim will examine possible mediators of treatment outcome. In addition, the weekly dose of exercise, the extent to which exercise generates positive affect, and engagement in enjoyable or meaningful aspects of life will be explored.
The purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer.
Millions of Americans have diabetes or prediabetes, for which regular physical activity can reduce risks of unfavorable outcomes of these conditions. This study will test the effects of an evidence-based intervention in the primary care setting on increasing physical activity among these individuals. If effective, it can be broadly implemented in primary care.
Physical activity (PA) has physical, emotional, and cognitive benefits for seniors (e.g., increased strength and balance, reduced frailty, fewer falls, improved brain function, lower mortality risk), yet many seniors have limited access to exercise options due to numerous barriers (e.g., transportation concerns, financial costs, fear of injury/falling). This project will overcome common exercise barriers by creating an interactive web-enabled TV program (i.e., Smart TV), adapted from research-based PA protocols, to be implemented in an Independent Living Facility (ILF) setting. A web-based prototype will be developed, and ILF residents and administrators will be able to create, use, and evaluate a customizable exercise program tailored to the individual's preferred type of exercise, intensity, and duration.
The purpose of the study is to test an intervention that uses a mobile game to encourage increased physical activity among adults.
The current study involves conducting an intervention based on self-determination theory (SDT) and motivational interviewing (MI) to promote physical activity in a racially-diverse sample. It is expected that this intervention will successfully increase physical activity in participants.
Physical activity and exercise help manage symptoms like fatigue in people living with multiple sclerosis (MS). Despite research supporting physical activity participation, people with MS are often insufficiently active to reach health benefits. Promotional efforts that are sustainable within the United States healthcare system are needed. This project is a pilot randomized controlled trial examining the feasibility of a consultative physical therapy intervention for increasing physical activity engagement.
The goal of the LEAP project is to improve the health and well-being of cancer survivors and their co-survivors living in persistent poverty areas by providing healthy behavior change support. This will be done by engaging the community in adapting beneficial approaches for promoting healthy diet and regular physical activity into a program for cancer survivors and co-survivors that is appropriate for the persistent poverty context and social determinants of health.
The Fit2Play prospective cohort study examines the effects of a park-based youth physical activity afterschool program on youth participant fitness and mental health outcomes. Duke will perform a secondary analysis of the data collected as part of the Fit2Play prospective cohort study run by Miami-Dade County Parks and Recreation.
Cluster randomized trial to evaluate the impact of a health promotion intervention (the SI! - Program NYC) on the adapted Ideal Cardiovascular Health score (aICH) in children enrolled in New York City elementary schools.
This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology. There will be two phases for this project. The first phase is the "WE BEAT Group Wellness Education Program" and participants will be transitioned into the phase two HEART Club following phase one. The trial will look at feasibility and acceptability of the program. Additional hypothesis include home whether exercise interventions can: * be delivered without any associated serious cardiac events; * will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline. * will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline. * will result in increased step counts measured monthly from baseline to end of intervention * will improve self-reported quality of life from baseline to post-intervention. * will result in increased patient reported activity level from baseline to post-intervention
Osteoarthritis (OA) is a leading cause of disability worldwide that affects millions of Americans each year. Posttraumatic OA (PTOA) significantly impacts patients after anterior cruciate ligament (ACL) injury and ACL reconstruction (ACLR) with approximately 50% of patients developing PTOA within 20 years of injury or surgery. Knee joint mechanical loading measured via physical activity (i.e. daily steps) is insufficient in individuals after ACLR compared to uninjured individuals. Establishing the beneficial effects of physical activity to promote optimal free-living knee joint mechanical loading and improve knee joint health will aid in the development of cost-effective interventions that prevent PTOA and health burden of the disease.
The identification of intermittent fasting as an alternative method to traditional weight maintenance protocols could have a significant impact on preventing body weight regain common after successful weight loss, and potentially lead to a reduction in pharmaceutical and clinical costs related to the care of overweight and obese adults.
The objectives of this study are to determine the feasibility and potential efficacy of remotely delivered group exercise sessions to increase daily moderate to vigorous physical activity in adults with Down syndrome, relative to a usual care control. Participants will be randomized to attend 40 min remotely delivered group moderate to vigorous physical activity (MVPA) sessions at low frequency (1 session/wk.,RL), high frequency (3 sessions/wk., RH), or usual care control usual care control (UC). In addition to the group MVPA sessions, participants in both the RL and RH groups will also receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. Content for both the RL and RH arms will be identical with the exception of group session frequency (1 vs. 3/wk.). Participants in the UC arm will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education).The primary aim is to Assess daily MVPA (min) in the RL, RH, and UC arms at baseline, 3, 6, 9, and 12 mos., and obtain effect sizes for change in MVPA over 12-mos.Secondary Aim 1 is to assess the impact of MVPA on cardiovascular fitness, quality of life, cognitive function, and brain parameters related to Alzheimer's Disease (whole and regional brain volume, functional connectivity, and cerebral blood flow) at baseline, 6, and 12 mos. Secondary Aim 2 will determine the feasibility (retention, session attendance, use of recorded sessions (RH/RL only) of RL, RH, and UC interventions.
Implementation of physical activity promotion in routine health care delivery is low because of multiple barriers including insufficient health system support, care team coordination, and scarcity of community resources for referring patients and technology tools for sustaining lifestyle changes. This study is a pilot project to test the feasibility of implementing a physical activity promotion protocol, including routine evaluation of patient's physical activity levels and provision of educational material in the clinical workflow. Physically inactive adult patients with at least one documented cardiovascular disease risk factor will be invited to participate in physical activity intervention. Patients will be randomized to receive a wearable device or a smartphone app to objectively monitor their physical activity. Participants will be further randomized to receive automated motivational text messages, or a personalized motivational message, or no messages. Participants will be followed through the 12 week intervention period and an additional 12 weeks with no intervention.
The study will explore the capacity for a lifestyle modification in firefighters to improve blood pressure, blood vessel stiffness, inflammation, and reduce oxidative stress. The study will be a pre- post-testing controlled trial with three groups. The intervention will be a weekly circuit workout program and a Mediterranean (high fruit/vegetable) diet. The groups will be firefighters with \>10yrs experience, firefighters with \<10yrs experience, and control Non-firefighters.
The purpose of this study is to determine the individual and combined effectiveness of two smartphone-based tools for improving physical activity. The first is an individualized and guided goal-setting module, and the second uses "points", "levels", and "badges" to provide instant positive feedback throughout the program. It is hypothesized that both components will be effective, and greater effects will be noted for those receiving both components.
This 4-week pilot study is designed to test the feasibility, adherence, and effectiveness of a cell phone text message program for lifestyle goal setting among adolescents with type 1 or type 2 diabetes. The study entails a small-scale randomized controlled trial with pre-post test of a mobile text message program.
The objective of this study is to conduct a randomized controlled pilot study to examine the efficacy, feasibility and safety of the SystemCHANGE™(SC) health promotion and wellness program in adults with disabling conditions. Particularly, the study will focus on developing a program of research on adapting and testing SC weight management interventions in overweight and obese stroke survivors and persons with chronic inflammatory autoimmune/immune-mediated diseases, specifically those with multiple sclerosis (MS) and rheumatoid arthritis (RA).
The primary purpose of this study was to determine the effect of dietary weight-loss, exercise training, or a combination of both on physical function in overweight and obese adults with knee osteoarthritis (OA). In secondary analyses, the effect of weight-loss and/or exercise on OA progression, self-reported pain and inflammation were examined. In post-trial analyses, the effect of dietary weight-loss on total mortality was determined.
The purpose of this study is to determine whether educating parents about health and behavior management techniques will increase physical activity, calcium intake, fitness, and bone density in their children.
Hockey Fans in Training (Hockey FIT) is a 12-month (3-month active phase and 9-month minimally-supported phase) weight loss and healthy lifestyle program for middle-aged, male hockey fans with overweight or obesity, delivered by trained coaches in collaboration with major junior or professional hockey teams and implementation partners (e.g., YMCAs, local fitness facilities, and universities) in Canada and the United States. In the proposed study, a minimum of 32 sites (affiliated with hockey teams and local implementation partners) will be randomly assigned to either immediate delivery (Hockey FIT program) or delayed delivery (wait-list control). At each site, male hockey fans at risk for chronic diseases will be recruited to take part in the study (note: the goal is to recruit approximately 40 men/site). Sites assigned to the delayed delivery group will offer the Hockey FIT program to their enrolled participants after 12 months. Through the Hockey FIT program, the investigators aim to promote weight loss, increase physical activity levels, and improve other health measures through a cost-effective solution that is acceptable and appealing to men who have overweight or obesity.
The purpose of this pilot study is to estimate the efficacy of a mobile phone based physical activity intervention in sedentary men and women.