Search results for "Randomized Controlled Trial"
showing 10 items of 2199 documents
Sense of coherence: effect on adherence and response to resistance training in older people with hip fracture history.
2013
Our aim was to study the effects of sense of coherence (SOC) on training adherence and interindividual changes in muscle strength, mobility, and balance after resistance training in older people with hip fracture history. These are secondary analyses of a 12-week randomized controlled trial of progressive resistance training in 60- to 85-year-old community-dwelling people 0.5–7 years after hip fracture (n = 45; ISRCTN34271567). Pre- and posttrial assessments included SOC, knee extension strength, walking speed, timed up-and-go (TUG), and Berg Balance Scale (BBS). Group-by-SOC interaction effects (repeated-measures ANOVA) were statistically significant for TUG (p = .005) and BBS (p = .040), …
Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial …
2015
BACKGROUND: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagon-like peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated.METHODS: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population …
Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
2019
Background: Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear. Methods: In an international trial with a two-by-two factorial design, we randomly assigned patients with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y12 inhibitor to receive apixaban or a vitamin K antagonist and to receive aspirin or matching placebo for 6 months. The primary outcome was major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and a composite of ischemic events. Results: Enroll…
Causes of ineligibility in randomized controlled trials and long-term mortality in patients with non-ST-segment elevation acute coronary syndromes
2006
To determine the long-term mortality of patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) that are eligible versus those not eligible in randomized controlled trials (RCT), and how each exclusion criteria is associated with outcome.Common causes of exclusion in six published RCT on intravenous antithrombotic therapy were prospectively assessed in a cohort of 452 consecutive patients with NSTEACS that were followed for up to 3 years.Forty-one percent of patients had one or more exclusion criteria establishing the ineligible group. These patients were older, more likely to have coronary risk factors, ischemic ECG changes, heart failure at admission, higher creatinine l…
Arrhythmia Termination Versus Elimination of Dormant Pulmonary Vein Conduction as a Procedural End Point of Catheter Ablation for Paroxysmal Atrial F…
2015
Background— Pulmonary vein isolation (PVI) is still associated with a substantial number of arrhythmia recurrences in paroxysmal atrial fibrillation (AF). This prospective, randomized study aimed to compare 2 different procedural strategies. Methods and Results— A total of 152 patients undergoing de novo ablation for paroxysmal AF were randomized to 2 different treatment arms. The procedure in group A consisted of PVI exclusively. In this group, all isolated PVs were challenged with adenosine to reveal and ablate dormant conduction. In group B, PVI was performed with the patient either in spontaneous or in induced AF. If AF did not terminate with PVI, ablation was continued by targeting ex…
A brief intervention to increase physical activity behavior among adolescents using mental simulations and action planning
2016
This study evaluated the effectiveness of a brief integrated theory-based intervention to increase physical activity (PA) among adolescents over a three-month follow-up period. A 2 (mental simulation: present vs. absent) × 2 (action planning: present vs. absent) × 4 (time: baseline vs. one-month vs. two-month vs. three-month follow-up) mixed-model randomized controlled design was adopted. Adolescents aged 14-15 years (N = 267) completed baseline psychological measures and self-reported PA followed by the relevant intervention manipulation, if appropriate, with follow-up measures collected one, two, and three months later. Results revealed no significant effects for the mental simulation and…
Slackline Training in Children with Spastic Cerebral Palsy: A Randomized Clinical Trial
2020
Objective: To assess whether a slackline intervention program improves postural control in children/adolescents with spastic cerebral palsy (CP). Design: Randomized controlled trial. Setting: Patients&rsquo
The healthy body image (HBI) intervention: Effects of a school-based cluster-randomized controlled trial with 12-months follow-up
2019
Published by Elsevier Ltd. Under a Creative Commons license We examined the effects of the Healthy Body Image (HBI) intervention on positive embodiment and health-related quality of life among Norwegian high school students. The intervention comprised three interactive workshops, with body image, media literacy, and lifestyle as main themes. In total, 2,446 12th grade boys (43%) and girls (mean age 16.8 years) from 30 high schools participated in a cluster-randomized controlled study with the HBI intervention and a control condition as the study arms. Data were collected at baseline, post-intervention, 3- and 12-months follow-up, and analysed using linear mixed regression models. The HBI in…
Experiences from a randomised, controlled trial on cycling to school: does cycling increase cardiorespiratory fitness?
2012
Aims: The objective of the present study was to investigate the effect of a 12-week randomised controlled cycling-to-school trial on cardiorespiratory fitness. Methods: A total of 53 10- to 13-year-old children from one public school were included. The children were randomised into either a cycling group or a control group. The cycling group was encouraged to cycle to and from school each day during a period of 12 weeks. Peak oxygen consumption (VO2peak) and anthropometrical data (weight and height) were measured at baseline and at the end of the 12-week period. Results: No significant differences were observed in VO2peak change over the 12-week period between the cycling group and the con…
The effect of a school-based intervention on physical activity, cardiorespiratory fitness and muscle strength : the School in Motion cluster randomiz…
2020
Abstract Background Physical activity (PA) declines throughout adolescence, therefore PA promotion during this period is important. We analyzed the effect of two school-based PA interventions on daily PA levels, cardiorespiratory fitness (CRF) and muscle strength among adolescents. Methods For the nine-month School in Motion intervention study (ScIM), we cluster-randomized 30 Norwegian secondary schools (N = 2084, mean age [SD] = 14 [0.3] years) to one of three study arms. The physically active learning (PAL) intervention included 30 min physically active learning, 30 min PA and a 60 min physical education (PE) lesson per week. The Don’t worry-Be happy (DWBH) intervention included a 60 min …