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182 active trials for Physical Activity

A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement

Background: The definitive treatment for knee osteoarthritis is Total Knee Replacement (TKR), which results in clinically meaningful improvements in pain and physical function. However, evidence suggests that physical activity remains unchanged after TKR. This randomized clinical trial is investigating the efficacy, fidelity, and safety of a physical therapist administered physical activity intervention for people after TKR. Methods/Design: One hundred and twenty-five individuals, over the age of 45, who seek outpatient Physical Therapy (PT) following a unilateral TKR will be randomized into a control and intervention group. The intervention group will receive a weekly physical activity intervention during PT, which includes a FitbitTM monitor, individualized step goals, and face-to-face feedback provided by the physical therapist. Efficacy of the intervention will be measured by minutes/week spent in Moderate-to-Vigorous Physical Activity (MPVA) using an Actigraph GT3X monitor from enrollment to discharge, 6 months and 12 months from discharge from PT. The association of self-efficacy for exercise and kinesiophobia with physical activity will also be measured at the same time points. Fidelity and safety of the intervention will be assessed during outpatient PT. Discussion: This study is designed to fill a critical clinical need to increase physical activity after TKR. The primary objective of the study is to evaluate the efficacy of a physical therapist administered physical activity intervention for people after TKR. The secondary objectives are to evaluate the fidelity and safety of a physical therapist administered physical activity intervention for people after TKR and to investigate changes in self-reported and performance-based physical function after a physical therapist administered physical activity intervention for people after TKR. The tertiary objective is to explore the association of psychosocial factors with physical activity 6 and 12 months after discharge from a physical therapist administered physical activity intervention for people after TKR. The findings will be used to support a large multi-site clinical trial to test the effectiveness, implementation, and cost of this intervention.

Start: July 2017
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement

14.44% of the Spanish population is over 70 years old and Aging as a normal process is characterized by gradual modifications in the physiological functions of the different systems, so that as age progresses, deterioration can lead to imbalances and alterations in health that cause diseases or traumatic processes. Within these processes, vestibular loss occurs normally in the face of healthy aging and, encompassed within this progressive dysfunction, various symptoms such as dizziness, imbalances, facial and limb weakness, confusion or headache may occur. Functional status is the best indicator of the overall health status of the elderly person. Identifying these indicators as soon as possible is the best way to prevent functional decline and promote active aging and life expectancy free of disability. For this reason, there are strategies that are currently a priority in health systems. The special COVID circumstances eliminate the possibility of group work and invite the realization at home or individually of workshops or collective exercises In the field of physiotherapy, vestibular exercises have shown efficacy for improving balance and reducing the risk of falls in cognitively intact people without vestibular impairment, being a specific approach to vestibular rehabilitation for the reduction of dizziness and imbalances , as it facilitates the compensation of the Central Nervous System. physiotherapy intervention has been shown in various studies to be effective in improving balance and reducing the risk of falls in older people. Also considering that the control of body balance in the elderly depends not only on the vestibular system, but also on the correlations between all the other systems, it seems interesting to add exercises with multiple components, since it would add effects of improvement in functional independence of people greater for daily activities and control of body balance. Therapeutic physical exercise is an effective non-pharmacological strategy to improve the functional condition of the elderly and although it is known that there are various exercise modalities that improve physical function and quality of life, The Clinical Practice Guidelines emphasize the importance of multicomponent / multimodal exercise for this population group

Start: June 2021
Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months

This study aims to assess the impact of a home-visiting program, called "Family Spirit Nurture" (FSN), on reducing early childhood obesity in American Indian (AI) children. The FSN intervention targets parent feeding practices, young children's diet and physical activity (PA) and early childhood (0-2 years of age) weight status, all associated with risk for early childhood obesity and, consequently, risk for obesity over the life course. The investigators will also explore whether maternal psychosocial factors (stress, depression and substance use), household food/water security and/or constrained physical activity environments moderate FSN intervention impacts on: mother's feeding behaviors for infants and toddlers; and, children's diets, PA patterns, and weight status. Finally, the investigators will examine how maternal/infant characteristics, diet and behaviors impact the underlying biologic mechanisms of early childhood obesity and whether social and behavioral interventions can impact infant metabolic health. The investigators evaluation will employ a randomized controlled design, in which both the intervention and comparison condition receive assisted transportation to prenatal and well-baby visits (called "Optimized Standard Care"), and the comparison condition also receives potentially beneficial injury prevention education at 8 assessment visits. Primary Aims: Efficacy of Family Spirit Nurture (FSN) + Optimized Standard Care (OSC) versus Injury Prevention Education (IPE) + OSC will be assessed for each of the following from birth to 24 months postpartum: Aim 1. Mothers' implementation of recommended feeding behaviors. Hypothesis 1. FSN + OSC mothers will be more likely to meet breastfeeding and complementary feeding recommendations and engage in responsive parenting/feeding behaviors compared to IPE + OSC mothers. Aim 2. Children's consumption of healthy diet and physical activity engagement. Hypothesis 2. FSN + OSC children will consume more fruits and vegetables and fewer calories from sugar sweetened beverages (SSB), snacks and desserts, and they will have higher physical activity and reduced screen time/other sedentary activities compared to IPE + OSC children. Aim 3. Children's weight status. Hypothesis 3. Mean BMI z-scores for FSN + OSC children will be closer to zero (the mean age- and sex- specific BMI z-score for the World Health Organization standard reference population) compared to IPE + OSC children. Secondary Aims: Secondary Aim 1. To explore whether maternal psychosocial factors (stress, depression and substance use), and household food/beverage security and/or constrained physical activity environments moderate FSN intervention impacts on: infant and young children's feeding behaviors; and, infant/young children's diets, PA patterns, and weight status. Secondary Aim 2. To explore how maternal/infant characteristics, diet and behaviors impact the underlying biologic mechanisms of early childhood obesity, and whether social and behavioral interventions can impact infant metabolic health. Aim 2a. At delivery, examine how measures of infant metabolic health (fasting glucose, insulin, leptin, adiponectin, lipids, and c-reactive protein) are a) correlated with maternal biologic measures of metabolic health (fasting glucose, insulin, leptin, adiponectin, lipids, and c-reactive protein) and b) are impacted by sociodemographic, biological and psychosocial characteristics of mothers at baseline (e.g. age, parity, water/food security, BMI, gestational weight gain, gestational diabetes, depression, perceived stress). Hypothesis: Infant biologic measures of metabolic health will be highly correlated with maternal levels of metabolic health at birth and will vary by maternal baseline characteristics. Aim 2b. Between delivery and 12 months postpartum, examine how biologic measures of infant metabolic health change in relation to a) maternal biologic measures of metabolic health, b) sociodemographic, biological and psychosocial characteristics of mothers at baseline, and c) maternal/infant behaviors (e.g. responsive feeding practices, infant diet, introduction of sugar-sweetened beverages, early physical activity, etc.). Hypothesis: Biologic measures of infant metabolic health over the first 12 months of life will begin to diverge from maternal levels; and, infant metabolic health between delivery and 12 months postpartum will vary by maternal baseline characteristics and maternal/infant behaviors across study groups. Aim 2c. Infant metabolic health. Hypothesis: FSN + OSC infants will have better metabolic health (defined by fasting glucose, insulin, leptin, adiponectin, lipid and c-reactive protein levels) at 12 months postpartum compared with IPE + OSC infants.

Start: September 2017
Healthy Frio: A Rural Community Partnership to Advance Latino Obesity Research

Much has been learned about the efficacy and effectiveness of comprehensive healthy lifestyle interventions to reduce obesity. Few studies have been translated into rural settings or among Latinos. Y Living is an evidence-based family-focused intervention (FI) designed for urban Latino families. The FI is a 12-week behavioral modification program grounded in social cognitive theory, designed to engage the whole family in lifestyle changes by developing knowledge and skills in physical activity and healthy eating, building skills in goal-setting and self-monitoring, and creating a supportive home environment. Researchers will engage community partners in formative research to adapt the current FI for rural Latino families. Two parallel delivery methods of the FI will be developed and tested: 1) in-person group setting at a community center (FI-IP) and 2) home-based delivered remotely with technology (FI-RT). Both will be designed to address the unique social, cultural and environmental factors facing rural Latino families. The FI-RT will take advantage of innovative modern technology and e-Learning to increase program availability, accessibility and participation in rural settings. Researchers will conduct a 3-arm randomized controlled trial (RCT) to compare effectiveness of the two delivery approaches on weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese Latino parent-child pairs versus control. The researchers will recruit 270 obese Latino adults (ages 21-65) with a child (ages 8-17) from three primary care practices in rural South Texas. These parent-child pairs will be randomized to one of three arms stratified by clinic: 1) FI-IP (n=90); 2) FI-RT (n=90); or 3) control group (n=90). Primary specific aims are to: 1) Conduct community-engaged formative studies to transform the existing FI into two unique delivery methods (FI-IP and FI-RT) for use in a subsequent RCT in a rural Latino community; and 2) Conduct a RCT to evaluate the comparative effectiveness of FI-IP and FI-RT to address weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese rural Latino adults compared with adult participants in control group at immediate post intervention (3 months), after a 3-month maintenance program (6 months post randomization) and a 6-month follow-up (12 months post randomization). A secondary aim is to examine the impact of FI-IP and FI-RT children's weight and energy balance behaviors.

Start: November 2017
Cancer Adverse Effects PReventIon With Care & Exercise: the CAPRICE Study

Breast cancer is the most common cancer among women worldwide. Similarly, Hodgkin and non- Hodgkin lymphomas make up two of the most prevalent cancers in men and women. Even though remarkable improvements in cancer-free survival have been achieved in the last decades, the development of cardiac toxicity, associated with anthracycline-based chemotherapy (Anth-bC) counteracts the improvements in survival in these patient groups. One of the first clinical manifestation of Anth-bC cardiotoxicity is diastolic dysfunction, with further symptoms being left ventricular dysfunction and heart failure as well as a decline in exercise tolerance. Besides the direct cardiotoxic effects of anticancer treatment, many drugs also have adverse effects on the vascular endothelium. The concept of 'Exercise is Medicine' has become well established in exercise-oncology research. Exercise therapy is now considered a safe and well-tolerated adjunct therapy inducing beneficial effects on body composition, aerobic fitness and muscular strength, pain and fatigue, quality of life (QoL), depressive symptoms, and all cause survival. However, there is insufficient data on the superiority of performing exercise training therapy before and during chemotherapy with regard to cardiotoxic and cardiovascular side effects. Further, there is no data on patient preference for and barriers toward different timings of exercise training therapy. Therefore, the aim of the study is to compare left ventricular (LV) function measured by LV global longitudinal strain (GLS) in breast cancer and lymphoma patients undergoing Anth-bC randomised to completing an exercise-based rehabilitation programme during chemotherapy to those randomised to complete the programme after chemotherapy. Further, blood samples will be drawn to analyse biomarkers of myocardial injury (brain natriuretic peptide and high-sensitive cardiac troponin). Additional measurements include aortic distensibility as part of the echocardiographic examination and exercise capacity through cardiopulmonary exercise testing. QoL and fatigue will be assessed in a questionnaire, compliance with exercise training through monitoring and patient preference at 3 and 6 months will be evaluated through an interview. Cardiovascular risk factors will be assessed through body composition, 24h ambulatory blood pressure monitoring, 24h electrocardiogram and the analysis of established blood markers. Women and men aged 18 years and older with histologically confirmed breast cancer or lymphoma (ECOG grade 0-2) who are Anth-bC naïve and with reasonable life expectancy will be included in the study. The exercise programme is part of onco-rehabilitation programmes at the Inselspital Bern, the Spital AG Thun and the Bürgerspital Solothurn. Programmes last for 12 weeks and offer two supervised sessions per week (@ 60-90 min). They usually contain an endurance component (e.g. 40 min of cycling) and a strength, agility or relaxation component. Patients are encouraged to complete a third exercise session per week at home or elsewhere. Home-based training and general physical activity will be assessed by a questionnaire and an activity monitor. A total of 120 patients will be recruited. Measurements will be performed at baseline, after 3 months (week 13) and after 6 months (week 26).

Start: May 2019