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PloS One 2013Physical activity (PA) typically declines throughout pregnancy. Low levels of PA are associated with excessive weight gain and subsequently increase risk of... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Physical activity (PA) typically declines throughout pregnancy. Low levels of PA are associated with excessive weight gain and subsequently increase risk of pre-eclampsia, gestational diabetes mellitus, hypertension disorders, delivery by caesarean section and stillbirth. Systematic reviews on PA during pregnancy have not explored the efficacy of behaviour change techniques or related theory in altering PA behaviour. This systematic review evaluated the content of PA interventions to reduce the decline of PA in pregnant women with a specific emphasis on the behaviour change techniques employed to elicit this change.
SEARCH AND REVIEW METHODOLOGY
Literature searches were conducted in eight databases. Strict inclusion and exclusion criteria were employed. Two reviewers independently evaluated each intervention using the behaviour change techniques (BCT) taxonomy to identify the specific behaviour change techniques employed. Two reviewers independently assessed the risk of bias using the guidelines from the Cochrane Collaboration. Overall quality was determined using the GRADE approach.
FINDINGS
A total of 1140 potentially eligible papers were identified from which 14 studies were selected for inclusion. Interventions included counselling (n = 6), structured exercise (n = 6) and education (n = 2). Common behaviour change techniques employed in these studies were goal setting and planning, feedback, repetition and substitution, shaping knowledge and comparison of behaviours. Regular face-to-face meetings were also commonly employed. PA change over time in intervention groups ranged from increases of 28% to decreases of 25%. In 8 out of 10 studies, which provided adequate data, participants in the intervention group were more physically active post intervention than controls.
CONCLUSIONS AND IMPLICATIONS
Physical activity interventions incorporating behaviour change techniques help reduce the decline in PA throughout pregnancy. Range of behaviour change techniques can be implemented to reduce this decline including goals and planning, shaping knowledge and comparison of outcomes. A lack of high quality interventions hampers conclusions of intervention effectiveness.
Topics: Adaptation, Psychological; Exercise; Female; Humans; Motor Activity; Pregnancy; Pregnancy Complications; Risk Factors; Sedentary Behavior
PubMed: 23799096
DOI: 10.1371/journal.pone.0066385 -
PloS One 2023Laughter as an expression of humor has been recognized as good medicine for centuries. The health benefits of humor-induced well-being remain unclear and thus we... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Laughter as an expression of humor has been recognized as good medicine for centuries. The health benefits of humor-induced well-being remain unclear and thus we conducted a systematic review and meta-analysis of interventional studies to evaluate the impact of spontaneous laughter on stress response as measured by cortisol levels.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
MEDLINE/PubMed, EMBASE, PsycINFO, Scopus, and Clinicaltrials.gov.
ELIGIBILITY CRITERIA
Interventional studies, which could be either randomized placebo-controlled trials (RCTs) or quasi-experimental studies, conducted in adults that compared any spontaneous laughter intervention to a controlled setting and reported changes in cortisol levels were selected.
DATA EXTRACTION AND SYNTHESIS
We examined the impact of laughter on percentage change in cortisol levels by calculating pooled estimates of the absolute differences between arithmetic means before and after interventions as compared to control using random-effects model.
RESULTS
Eight studies (315 participants; mean age 38.6) met our inclusion criteria; four were RCTs and four were quasi-experiment studies. Five studies evaluated the impact of watching a humor/comedy video, two studies evaluating laughter sessions administered by a trained laughter therapist, and one study evaluating a self-administered laughter program. Pooling these data showed a significant reduction in cortisol levels by 31.9% (95%CI -47.7% to -16.3%) induced by laughter intervention compared to control group with no evidence of publication bias (P = 0.66). Sensitivity analyses demonstrated that even a single laughter session induced a significant reduction of 36.7% in cortisol (95%CI -52.5% to -20.8%). In addition, analyses including the four RCTs reinforced these results by demonstrating a significant reduction in cortisol levels promoted by laughter as compared to the placebo arm [-37.2% (95%CI -56.3% to -18.1%)].
CONCLUSIONS
Current evidence demonstrates that spontaneous laughter is associated with greater reduction in cortisol levels as compared with usual activities, suggesting laughter as a potential adjunctive medical therapy to improve well-being.
TRIAL REGISTRATION
Registration number: CRD42021267972.
Topics: Adult; Humans; Hydrocortisone; Laughter; Medicine; Allied Health Personnel; Control Groups
PubMed: 37220157
DOI: 10.1371/journal.pone.0286260 -
PloS One 2023A blood-based integrated classifier (IC) has been clinically validated to improve accuracy in assessing probability of cancer risk (pCA) for pulmonary nodules (PN). This... (Observational Study)
Observational Study
A blood-based integrated classifier (IC) has been clinically validated to improve accuracy in assessing probability of cancer risk (pCA) for pulmonary nodules (PN). This study evaluated the clinical utility of this biomarker for its ability to reduce invasive procedures in patients with pre-test pCA ≤ 50%. This was a propensity score matching (PSM) cohort study comparing patients in the ORACLE prospective, multicenter, observational registry to control patients treated with usual care. This study enrolled patients meeting the intended use criteria for IC testing: pCA ≤ 50%, age ≥40 years, nodule diameter 8-30 mm, and no history of lung cancer and/or active cancer (except for non-melanomatous skin cancer) within 5 years. The primary aim of this study was to evaluate invasive procedure use on benign PNs of registry patients as compared to control patients. A total of 280 IC tested, and 278 control patients met eligibility and analysis criteria and 197 were in each group after PSM (IC and control groups). Patients in the IC group were 74% less likely to undergo an invasive procedure as compared to the control group (absolute difference 14%, p <0.001) indicating that for every 7 patients tested, one unnecessary invasive procedure was avoided. Invasive procedure reduction corresponded to a reduction in risk classification, with 71 patients (36%) in the IC group classified as low risk (pCA < 5%). The proportion of IC group patients with malignant PNs sent to surveillance were not statistically different than the control group, 7.5% vs 3.5% for the IC vs. control groups, respectively (absolute difference 3.91%, p 0.075). The IC for patients with a newly discovered PN has demonstrated valuable clinical utility in a real-world setting. Use of this biomarker can change physicians' practice and reduce invasive procedures in patients with benign pulmonary nodules. Trial registration: Clinical trial registration: ClinicalTrials.gov NCT03766958.
Topics: Humans; Adult; Cohort Studies; Prospective Studies; Lung Neoplasms; Control Groups; Multiple Pulmonary Nodules; Propensity Score
PubMed: 37432960
DOI: 10.1371/journal.pone.0287409 -
Clinical Trials (London, England) Jun 2023Randomized controlled trials offer the best design for eliminating bias in estimating treatment effects but can be slow and costly in rare disease research....
BACKGROUND
Randomized controlled trials offer the best design for eliminating bias in estimating treatment effects but can be slow and costly in rare disease research. Additionally, an equal randomization approach may not be optimal in studies in which prior evidence of superiority of one or more treatments exist. Supplementing prospectively enrolled, concurrent controls with historical controls can reduce recruitment requirements and provide patients a higher likelihood of enrolling in a new and possibly superior treatment arm. Appropriate methods need to be employed to ensure comparability of concurrent and historical controls to minimize bias and variability in the treatment effect estimates and reduce the chances of drawing incorrect conclusions regarding treatment benefit.
METHODS
MILES was a phase III placebo-controlled trial employing 1:1 randomization that led to US Food and Drug Administration approval of sirolimus for treating patients with lymphangioleiomyomatosis. We re-analyzed the MILES trial data to learn whether substituting concurrent controls with controls from a historical registry could have accelerated subject enrollment while leading to similar study conclusions. We used propensity score matching to identify exchangeable historical controls from a registry balancing the baseline characteristics of the two control groups. This allowed more new patients to be assigned to the sirolimus arm. We used trial data and simulations to estimate key outcomes under an array of alternative designs.
RESULTS
Borrowing information from historical controls would have allowed the trial to enroll fewer concurrent controls while leading to the same conclusion reached in the trial. Simulations showed similar statistical performance for borrowing as for the actual trial design without producing type I error inflation and preserving power for the same study size when concurrent and historical controls are comparable.
CONCLUSION
Substituting concurrent controls with propensity score-matched historical controls can allow more prospectively enrolled patients to be assigned to the active treatment and enable the trial to be conducted with smaller overall sample size, while maintaining covariate balance and study power and minimizing bias in response estimation. This approach does not fully eliminate the concern that introducing non-randomized historical controls in a trial may lead to bias in estimating treatment effects, and should be carefully considered on a case-by-case basis. Borrowing historical controls is best suited when conducting randomized controlled trials with conventional designs is challenging, as in rare disease research. High-quality data on covariates and outcomes must be available for candidate historical controls to ensure the validity of these designs. Additional precautions are needed to maintain blinding of the treatment assignment and to ensure comparability in the assessment of treatment safety.MILES ClinicalTrials.gov Number: NCT00414648.
Topics: Humans; Rare Diseases; Sample Size; Research Design; Control Groups; Sirolimus
PubMed: 36927115
DOI: 10.1177/17407745231158906 -
International Journal of Environmental... Jun 2023Studies show that physical activity, exercise, or sport reduces depressive symptoms in the general population. However, little is known about its effects on individuals... (Meta-Analysis)
Meta-Analysis Review
Studies show that physical activity, exercise, or sport reduces depressive symptoms in the general population. However, little is known about its effects on individuals with disabilities. Thus, this systematic review with meta-analysis aims to verify the effects of this practice on depressive symptoms in individuals with disabilities. The Pubmed, Web of Science, Scopus, and SportDiscus databases were used, with several descriptors and Boolean operators. A total of 1509 studies were identified through searching the databases. Studies that met the eligibility criteria were subsequently assessed for their methodological quality (Downs and Black scale), and a meta-analysis was performed. The -values that were obtained to test the null hypothesis, which states that there is no difference in means, showed = -2.294 and a corresponding -value = 0.022. We can, therefore, reject the null hypothesis in the sense that exercise seems to reduce depressive symptoms in individuals with disabilities. In sum, participants from the intervention group presented more probability of reducing depressive symptoms when compared to the control group (approximately -1.4 standard differences in means; 95% CI -2.602 to -0.204).
Topics: Humans; Depression; Exercise; Sports; Disabled Persons; Control Groups
PubMed: 37372720
DOI: 10.3390/ijerph20126134 -
The American Journal of Hospice &... Apr 2019Determining intervention efficacy depends as much on the control group as on the intervention, but little attention has been given to the control condition in...
BACKGROUND:
Determining intervention efficacy depends as much on the control group as on the intervention, but little attention has been given to the control condition in psychoeducational trials in palliative care.
OBJECTIVES:
To examine (1) research practice regarding control conditions that are neither usual care nor no-treatment controls in randomized trials of psychoeducational palliative care interventions and (2) the rationale and completeness of the descriptions of control conditions in trial reports.
METHODS:
PubMed, EMBASE, PsycINFO, and Web of Science were searched. After screening 1603 articles, 70 full-text articles were assessed for eligibility. The final sample included 9 trial reports. We used the Delphi list for quality assessment and the modified intervention taxonomy checklist to assess active intervention and control conditions.
RESULTS:
Four trials used an attention control designed to be equivalent to the structure of the active intervention. In another 4, the control condition included some aspects of attention control such that the mode of contact was similar to that in the active intervention, but either the amount or the intensity of attention was not similar. Only 3 trial reports explicitly stated the rationale for the choice of control condition. Although most reports contained delivery mode, materials, duration, frequency, and sequence, none described the qualifications or training required to deliver the control condition. Only 1 report mentioned the fidelity monitoring method, and none included fidelity data.
CONCLUSION:
Our review of psychoeducational trials in palliative care calls for researchers' attention to appropriate selection, design, conduct and report of control conditions.
Topics: Control Groups; Humans; Palliative Care; Patient Education as Topic; Randomized Controlled Trials as Topic
PubMed: 30343586
DOI: 10.1177/1049909118805936 -
Human Brain Mapping Jun 2021Upper and lower limb impairments are common in people with multiple sclerosis (pwMS), yet difficult to clinically identify in early stages of disease progression. Tasks...
Upper and lower limb impairments are common in people with multiple sclerosis (pwMS), yet difficult to clinically identify in early stages of disease progression. Tasks involving complex motor control can potentially reveal more subtle deficits in early stages, and can be performed during functional MRI (fMRI) acquisition, to investigate underlying neural mechanisms, providing markers for early motor progression. We investigated brain activation during visually guided force matching of hand or foot in 28 minimally disabled pwMS (Expanded Disability Status Scale (EDSS) < 4 and pyramidal and cerebellar Kurtzke Functional Systems Scores ≤ 2) and 17 healthy controls (HC) using ultra-high field 7-Tesla fMRI, allowing us to visualise sensorimotor network activity in high detail. Task activations and performance (tracking lag and error) were compared between groups, and correlations were performed. PwMS showed delayed (+124 s, p = .002) and more erroneous (+0.15 N, p = .001) lower limb tracking, together with lower cerebellar, occipital and superior parietal cortical activation compared to HC. Lower activity within these regions correlated with worse EDSS (p = .034), lower force error (p = .006) and higher lesion load (p < .05). Despite no differences in upper limb task performance, pwMS displayed lower inferior occipital cortical activation. These results demonstrate that ultra-high field fMRI during complex hand and foot tracking can identify subtle impairments in lower limb movements and upper and lower limb brain activity, and differentiates upper and lower limb impairments in minimally disabled pwMS.
Topics: Adult; Cerebral Cortex; Female; Foot; Hand; Humans; Magnetic Resonance Imaging; Male; Middle Aged; Motor Activity; Multiple Sclerosis, Relapsing-Remitting; Psychomotor Performance
PubMed: 33666314
DOI: 10.1002/hbm.25389 -
Obesity (Silver Spring, Md.) Jun 2008Children with better-developed motor skills may find it easier to be active and engage in more physical activity (PA) than those with less-developed motor skills. The...
Children with better-developed motor skills may find it easier to be active and engage in more physical activity (PA) than those with less-developed motor skills. The purpose of this study was to examine the relationship between motor skill performance and PA in preschool children. Participants were 80 three- and 118 four-year-old children. The Children's Activity and Movement in Preschool Study (CHAMPS) Motor Skill Protocol was used to assess process characteristics of six locomotor and six object control skills; scores were categorized as locomotor, object control, and total. The actigraph accelerometer was used to measure PA; data were expressed as percent of time spent in sedentary, light, moderate-to-vigorous PA (MVPA), and vigorous PA (VPA). Children in the highest tertile for total score spent significantly more time in MVPA (13.4% vs. 12.8% vs. 11.4%) and VPA (5% vs. 4.6% vs. 3.8%) than children in middle and lowest tertiles. Children in the highest tertile of locomotor scores spent significantly less time in sedentary activity than children in other tertiles and significantly more time in MVPA (13.4% vs. 11.6%) and VPA (4.9% vs. 3.8%) than children in the lowest tertile. There were no differences among tertiles for object control scores. Children with poorer motor skill performance were less active than children with better-developed motor skills. This relationship between motor skill performance and PA could be important to the health of children, particularly in obesity prevention. Clinicians should work with parents to monitor motor skills and to encourage children to engage in activities that promote motor skill performance.
Topics: Child Development; Child, Preschool; Data Collection; Female; Humans; Locomotion; Male; Motor Activity; Motor Skills; South Carolina; Task Performance and Analysis
PubMed: 18388895
DOI: 10.1038/oby.2008.214 -
International Journal of Environmental... Feb 2023(1) Background: Post-stroke presents motor function deficits, and one interesting possibility for practicing skills is the concept of bilateral transfer. Additionally,...
(1) Background: Post-stroke presents motor function deficits, and one interesting possibility for practicing skills is the concept of bilateral transfer. Additionally, there is evidence that the use of virtual reality is beneficial in improving upper limb function. We aimed to evaluate the transfer of motor performance of post-stroke and control groups in two different environments (real and virtual), as well as bilateral transfer, by changing the practice between paretic and non-paretic upper limbs. (2) Methods: We used a coincident timing task with a virtual (Kinect) or a real device (touch screen) in post-stroke and control groups; both groups practiced with bilateral transference. (3) Results: Were included 136 participants, 82 post-stroke and 54 controls. The control group presented better performance during most parts of the protocol; however, it was more evident when compared with the post-stroke paretic upper limb. We found bilateral transference mainly in Practice 2, with the paretic upper limb using the real interface method (touch screen), but only after Practice 1 with the virtual interface (Kinect), using the non-paretic upper limb. (4) Conclusions: The task with the greatest motor and cognitive demand (virtual-Kinect) provided transfer into the real interface, and bilateral transfer was observed in individuals post-stroke. However, this is more strongly observed when the virtual task was performed using the non-paretic upper limb first.
Topics: Humans; Cross-Sectional Studies; Stroke; Stroke Rehabilitation; Virtual Reality; Control Groups; Upper Extremity
PubMed: 36834000
DOI: 10.3390/ijerph20043301 -
Osteoporosis International : a Journal... Mar 2015An international consensus process resulted in exercise and physical activity recommendations for individuals with osteoporosis. Emphasis was placed on strength,...
Too Fit To Fracture: outcomes of a Delphi consensus process on physical activity and exercise recommendations for adults with osteoporosis with or without vertebral fractures.
UNLABELLED
An international consensus process resulted in exercise and physical activity recommendations for individuals with osteoporosis. Emphasis was placed on strength, balance, and postural alignment. Rather than providing generic restrictions, activity should be encouraged while considering impairments, fracture risk, activity history, and preference, and guidance on spine sparing techniques should be provided.
INTRODUCTION
The objectives of this study were to establish expert consensus on key questions posed by patients or health care providers regarding recommended assessment domains to inform exercise prescription, therapeutic goals of exercise, and physical activity and exercise recommendations for individuals with osteoporosis or osteoporotic vertebral fracture.
METHODS
The Too Fit To Fracture expert panel identified researchers and clinicians with expertise in exercise and osteoporosis and stakeholder groups. We delivered a modified online Delphi survey (two rounds) to establish consensus on assessment, exercise, and physical activities for three cases with varying risk (osteoporosis based on bone mineral density; 1 spine fracture and osteoporosis; multiple spine fractures, osteoporosis, hyperkyphosis, and pain). Duplicate content analyses of free text responses were performed.
RESULTS
Response rates were 52% (39/75) and 69% (48/70) for each round. Key consensus points are the following: (a) Current physical activity guidelines are appropriate for individuals with osteoporosis without spine fracture, but not for those with spine fracture; (b) after spine fracture, physical activity of moderate intensity is preferred to vigorous; (c) daily balance training and endurance training for spinal extensor muscles are recommended for all; (d) providing guidance on spine-sparing techniques (e.g., hip hinge) during activities of daily living or leisure, considering impairments, fracture risk, activity history, and preference, is recommended rather than providing generic restrictions (e.g., lifting <10 lbs, no twisting), but for those with vertebral fracture, especially in the presence of pain, multiple fractures, or hyperkyphosis, the risks of many activities may outweigh the benefits-physical therapist consultation is recommended. Examples of spine-sparing techniques and exercise prescription elements are provided.
CONCLUSIONS
Our recommendations guide health care providers on assessment, exercise prescription, and safe movement for individuals with osteoporosis.
Topics: Accidental Falls; Bone Density; Delphi Technique; Exercise Therapy; Humans; Motor Activity; Osteoporosis; Osteoporotic Fractures; Posture; Practice Guidelines as Topic; Spinal Fractures
PubMed: 25510579
DOI: 10.1007/s00198-014-2881-4