Considerations of Control Groups: Comparing Active-Control with No Treatment for Examining the Effects of Brief Intervention.

BACKGROUND: A large-scale online study completed by this research team found that brief psychological interventions were associated with high-intensity pleasant emotions and predicted performance. The present study extends this work using data from participants (n = 3376) who completed all self-report data and engaged in a performance task but who did not engage with an intervention or control condition and therefore present as an opportunistic no-treatment group. METHODS: 41,720 participants were selected from the process and outcome focus goals intervention groups, which were the successful interventions (n = 30,096), active-control (n = 3039), and no-treatment (n = 8585). Participants completed a competitive task four times: first as practice, second to establish a baseline, third following an opportunity to complete a brief psychological skills intervention, and lastly following an opportunity to repeat the intervention. Repeated measures MANOVA indicated that over four performance rounds, the intensity of positive emotions increased, performance improved, and the amount of effort participants exerted increased; however, these increases were significantly smaller in the no-treatment group. CONCLUSIONS: Findings suggest that not engaging in active training conditions had negative effects. We suggest that these findings have implications for the development and deployment of online interventions.

What Should Clinicians Tell Patients about Placebo and Nocebo Effects? Practical Considerations Based on Expert Consensus.

INTRODUCTION: Clinical and laboratory studies demonstrate that placebo and nocebo effects influence various symptoms and conditions after the administration of both inert and active treatments. OBJECTIVE: There is an increasing need for up-to-date recommendations on how to inform patients about placebo and nocebo effects in clinical practice and train clinicians how to disclose this information. METHODS: Based on previous clinical recommendations concerning placebo and nocebo effects, a 3-step, invitation-only Delphi study was conducted among an interdisciplinary group of internationally recognized experts. The study consisted of open- and closed-ended survey questions followed by a final expert meeting. The surveys were subdivided into 3 parts: (1) informing patients about placebo effects, (2) informing patients about nocebo effects, and (3) training clinicians how to communicate this information to the patients. RESULTS: There was consensus that communicating general information about placebo and nocebo effects to patients (e.g., explaining their role in treatment) could be beneficial, but that such information needs to be adjusted to match the specific clinical context (e.g., condition and treatment). Experts also agreed that training clinicians to communicate about placebo and nocebo effects should be a regular and integrated part of medical education that makes use of multiple formats, including face-to-face and online modalities. CONCLUSIONS: The current 3-step Delphi study provides consensus-based recommendations and practical considerations for disclosures about placebo and nocebo effects in clinical practice. Future research is needed on how to optimally tailor information to specific clinical conditions and patients' needs, and on developing standardized disclosure training modules for clinicians.

Understanding placebo and nocebo effects in the context of sport: A psychological perspective.

Research over the past 15 years on the placebo effect has substantiated its contribution to the efficacy of established treatments for a range of clinical conditions and identified its underlying mechanisms. There is also evidence that placebo effects contribute to the performance benefits of many ergogenic aids, and that performance can worsen when dummy treatments are associated with expectations of a harmful outcome (i.e. nocebo effect). Unfortunately, the bulk of sport research involving placebos and nocebos continues to be hampered by outdated definitions and conceptualizations of placebo effects and their mechanisms. This has implications not only for research but also application, as nearly 50% of athletes report experiencing a beneficial placebo effect, and a similar proportion of coaches report providing placebos to their athletes. The objective of this paper is to attempt to stimulate research by presenting updated definitions of placebo and nocebo effects in the context of sport, describing their major mechanisms and, highlighting the importance of the psychosocial context on placebo effects in the sport setting.

You don't need to administer a placebo to elicit a placebo effect: Social factors trigger neurobiological pathways to enhance sports performance.

The placebo effect is traditionally viewed as a positive outcome resulting from a person's belief that an inert substance is in fact an active drug. In this context, it is often viewed as an intrapsychic phenomenon. However, most placebo effects reported in scientific research result from social interactions. These might be explicit, such as the description and administration of a treatment by a practitioner, or less explicit, for example, the recipient's perceptions of the practitioner's credibility, expertise, or confidence. On this basis, placebo effects are arguably social in origin. Many phenomena in sport are likewise social in origin, from the facilitation effects of a home field crowd or a cohesive team, to anxiety induced by an expert opponent or perceived underperformance. Such social effects have been the subject of research not only in social psychology, but also in experimental physiology. Emergent research in cognitive and evolutionary anthropology suggests that these social effects can be examined as a form of placebo effect. This suggestion is not a speculative position predicated on social and placebo effects sharing similar environmental cues and outcomes, but one based on a growing database indicating that drug, placebo, and social effects operate via common neurobiological mechanisms. In this paper, we examine the theoretical and empirical overlap between placebo and social effects and describe emergent research reporting specific brain pathways activated by socio-environmental cues as well as by drugs and placebos. We do so from three perspectives: the competitor, the teammate, the researcher.

One-year surveillance of body mass index and cardiorespiratory fitness in UK primary school children in North West England and the impact of school deprivation level.

OBJECTIVES: Cardiorespiratory fitness (CRF) is independently associated with health and academic attainment in childhood and adolescence. Yet overweight/obesity remains the focus in public health policy. Surveillance of body mass index (BMI) and CRF considering school deprivation levels is limited. Therefore, we examined this in English primary schools. METHODS: Participants (n=409) were students (9-10 years) from 13 schools. BMI and CRF (20 m shuttle run) were measured at three time points across the academic year and a fourth after summer recess. RESULTS: BMI z-scores significantly decreased (p=0.015) from autumn (z=0.336 (95% CI 0.212 to 0.460)) to spring (z=0.252 (95% CI 0.132 to 0.371)), and then significantly increased (p=0.010) to summer (z=0.327 (95% CI 0.207 to 0.447)). CRF significantly increased (p<0.001) from autumn (z=0.091 (95% CI -0.014 to 0.196)) to spring (z=0.492 (95% CI 0.367 to 0.616)), no change (p=0.308) into summer (z=0.411 (95% CI 0.294 to 0.528)) and a significant decrease (p<0.001) into the following autumn term (z=0.125 (95% CI 0.021 to 0.230)). BMI was unaffected by deprivation; however, pupils from the most deprived areas saw significantly greater reductions in CRF compared with pupils from affluent areas. No time, or deprivation level, by sex interactions were found. CONCLUSION: Significant reductions in children's CRF occurred over the summer recess and were greater among children from schools in the most deprived areas. This may help inform future research into interventions targeting physical activity of schoolchildren, particularly over the summer recess.

Advancing the understanding of placebo effects in psychological outcomes of exercise: Lessons learned and future directions.

Despite the apparent strength of scientific evidence suggesting that psychological benefits result from both acute and chronic exercise, concerns remain regarding the extent to which these benefits are explained by placebo effects. Addressing these concerns is methodologically and at times conceptually challenging. However, developments in the conceptualisation and study of placebo effects from the fields of psychology, neuroscience, pharmacology, and human performance offer guidance for advancing the understanding of placebo effects in psychological responses to exercise. In clinical trials, expectations can be measured and experimentally manipulated to better understand the influence of placebo effects on treatment responses. Further, compelling evidence has shown that the contribution of placebo effects and their underlying neurobiological mechanisms to treatment effects can be measured without administering a traditional placebo (e.g. inert substance) by leveraging psychological factors such as expectations and conditioning. Hence, the purpose of this focused review is to integrate lessons such as these with the current body of literature on placebo effects in psychological responses to exercise and provide recommendations for future research directions.

The Placebo and Nocebo effect on sports performance: A systematic review.

The aim of this review was to determine the magnitude of the placebo and nocebo effect on sport performance. Articles published before March 2019 were located using Medline, Web of Science, PubMed, EBSCO, Science Direct, and Scopus. Studies that examined placebo and nocebo effects of an objective dependent variable on sports performance, which included a control or baseline condition, were included in the analysis. Studies were classified into two categories of ergogenic aids: (1) nutritional and (2) mechanical. Cohen's d effect sizes were calculated from 32 studies involving 1513 participants. Small to moderate placebo effects were found for both placebo (d = 0.36) and nocebo (d = 0.37) effects and when separated by nutritional (d = 0.35) and mechanical (d = 0.47) ergogenic aids. The pooled effect size revealed a small to moderate effect size across all studies (d = 0.38). Results suggest that placebo and nocebo effects can exert a small to moderate effect on sports performance.

Reconceptualizing the measurement of expectations to better understand placebo and nocebo effects in psychological responses to exercise.

The understanding of placebo and nocebo effects in psychological responses to exercise may be improved by measuring expectations. Despite availability of several validated expectation measures, we argue for using scales that take both positive and negative expectations for exercise-induced changes into account. A cross-sectional survey was used to collect information on positive and negative expectations pertaining to how exercise would affect 14 different outcomes related to psychological health (n = 966). Outcomes for which a majority of the sample (>50%) reported positive expectations for exercise-induced changes included: psychological well-being (75.3%), depression (74.3%), relaxation (74.2%), sleep quality (73.3%), stress (72.2%), anxiety (69.8%), energy (67.1%), and attention (60.2%). Outcomes for which a majority of the sample (>50%) reported a negative expectation for exercise-induced changes were muscle pain (66.3%), fatigue (57.3%), and joint pain (50.7%). Across all 14 outcomes, the percentage of participants with negative expectations for exercise-induced changes ranged from 5.9 to 66.3%. Elucidating the potential presence of placebo and nocebo effects through measurement of expectations may improve the understanding of variability in the direction and magnitude of exercise-related effects on psychological health. Although there were only 3 outcomes for which the majority of participants reported negative expectations, we found that negative expectations were present to some degree for all 14 outcomes. Thus, for researchers who wish to characterize expectations in studies of psychological responses to exercise, we recommend using measures that give equal consideration to positive and negative expectations.

Improved 1000-m Running Performance and Pacing Strategy With Caffeine and Placebo: A Balanced Placebo Design Study.

PURPOSE: To investigate the placebo effect of caffeine on pacing strategy and performance over 1000-m running time trials using a balanced placebo design. METHODS: Eleven well-trained male middle-distance athletes performed seven 1000-m time trials (1 familiarization, 2 baseline, and 4 experimental). Experimental trials consisted of the administration of 4 randomized treatments: informed caffeine/received caffeine, informed caffeine/received placebo, informed placebo/received caffeine, and informed placebo/received placebo. Split times were recorded at 200, 400, 600, 800, and 1000 m, and peak heart rate and rating of perceived exertion were recorded at the completion of the trial. RESULTS: Relative to baseline, participants ran faster during informed caffeine/received caffeine (d = 0.42) and informed caffeine/received placebo (d = 0.43). These changes were associated with an increased pace during the first half of the trial. No differences were shown in pacing or performance between baseline and the informed placebo/received caffeine (d = 0.21) and informed placebo/received placebo (d = 0.10). No differences were reported between treatments for peak heart rate (η2 = .084) and rating of perceived exertion (η2 = .009). CONCLUSIONS: The results indicate that the effect of believing to have ingested caffeine improved performance to the same magnitude as actually receiving caffeine. These improvements were associated with an increase in pace during the first half of the time trial.

Programming and supervision of resistance training leads to positive effects on strength and body composition: results from two randomised trials of community fitness programmes.

BACKGROUND: Many sedentary adults have high body fat along with low fitness, strength, and lean body mass (LBM) which are associated with poor health independently of body mass. Physical activity can aid in prevention, management, and treatment of numerous chronic conditions. The potential efficacy of resistance training (RT) in modifying risk factors for cardiovascular and metabolic disease is clear. However, RT is under researched in public health. We report community-based studies of RT in sedentary (Study 1), and overweight and pre-diabetic (Study 2) populations. METHODS: Study 1 - A semi randomised trial design (48-weeks): Participants choosing either a fitness centre approach, and randomised to structured-exercise (STRUC, n = 107), or free/unstructured gym use (FREE, n = 110), or not, and randomised to physical-activity-counselling (PAC, n = 71) or a measurement only comparator (CONT, n = 76). Study 2 - A randomised wait list controlled trial (12-weeks): Patients were randomly assigned to; traditional-supervised-exercise (STRUC, n = 30), physical-activity-counselling (PAC, n = 23), either combined (COMB, n = 39), or a wait-list comparator (CONT, n = 54). Outcomes for both were BF mass (kg), LBM (kg), BF percentage (%), and strength. RESULTS: Study 1: One-way ANCOVA revealed significant between group effects for BF% and LBM, but not for BF mass or strength. Post hoc paired comparisons revealed significantly greater change in LBM for the STRUC group compared with the CONT group. Within group changes using 95%CIs revealed significant changes only in the STRUC group for both BF% (- 4.1 to - 0.9%) and LBM (0.1 to 4.5 kg), and in FREE (8.2 to 28.5 kg) and STRUC (5.9 to 26.0 kg) for strength. Study 2: One-way ANCOVA did not reveal significant between group effects for strength, BF%, BF mass, or LBM. For strength, 95%CIs revealed significant within group changes for the STRUC (2.4 to 14.1 kg) and COMB (3.7 to 15.0 kg) groups. CONCLUSION: Strength increased in both studies across all RT treatments compared to controls, yet significant improvements in both strength and body-composition occurred only in programmed and/or supervised RT. As general increases in physical activity have limited impact upon body-composition, public health practitioners should structure interventions to include progressive RT. TRIAL REGISTRATION: Study 1: ISRCTN13024854 , retrospectively registered 20/02/2018. Study 2: ISRCTN13509468 , retrospectively registered 20/02/2018).

Different durations within the method of best practice affect the parameters of the speed-duration relationship.

The aim of the study was to determine whether estimates of the speed-duration relationship are affected using different time-trial (TT) field-based testing protocols, where exhaustive times were located within the generally recommended durations of 2-15 min. Ten triathletes (mean ± SD age: 31.0 ± 5.7 years; height: 1.81 ± 0.05 m; body mass: 76.5 ± 6.8 kg) performed two randomly assigned field tests to determine critical speed (CS) and the total distance covered above CS (D́). CS and D́ were obtained using two different protocols comprising three TT that were interspersed by 60 min passive rest. The TTs were 12, 7, and 3 min in Protocol I and 10, 5, and 2 min in Protocol II. A linear relationship of speed vs. the inverse of time (s = D́ × 1/t + CS) was used to determine parameter estimates. Significant differences were found for CS (p = 0.026), but not for D́ (p = 0.123). The effect size for CS (d = 0.305) was considered small, while that for D́ was considered moderate (d = 0.742). CS was significantly correlated between protocols (r = 0.934; p < 0.001), however, no correlation was found for D́ (r = 0.053; p = 0.884). The 95% limits of agreement were ±0.28m s-1 and ±73.9 m for CS and D́, respectively. These findings demonstrate that the choice of exhaustive times within commonly accepted durations results in different estimates of CS and D́, and thus protocols cannot be used interchangeably. The use of a consistent protocol is therefore recommended, when investigating or monitoring the speed-duration relationship estimates in well-trained athletes.

Studying placebo effects in model organisms will help us understand them in humans.

The placebo effect is widely recognized but important questions remain, for example whether the capacity to respond to a placebo is an evolved, and potentially ubiquitous trait, or an unpredictable side effect of another evolved process. Understanding this will determine the degree to which the physiology underlying placebo effects might be manipulated or harnessed to optimize medical treatments. We argue that placebo effects are cases of phenotypic plasticity where once predictable cues are now unpredictable. Importantly, this explains why placebo-like effects are observed in less complex organisms such as worms and flies. Further, this indicates that such species present significant opportunities to test hypotheses that would be ethically or pragmatically impossible in humans. This paradigm also suggests that data informative of human placebo effects pre-exist in studies of model organisms.

A higher effort-based paradigm in physical activity and exercise for public health: making the case for a greater emphasis on resistance training.

It is well known that physical activity and exercise is associated with a lower risk of a range of morbidities and all-cause mortality. Further, it appears that risk reductions are greater when physical activity and/or exercise is performed at a higher intensity of effort. Why this may be the case is perhaps explained by the accumulating evidence linking physical fitness and performance outcomes (e.g. cardiorespiratory fitness, strength, and muscle mass) also to morbidity and mortality risk. Current guidelines about the performance of moderate/vigorous physical activity using aerobic exercise modes focuses upon the accumulation of a minimum volume of physical activity and/or exercise, and have thus far produced disappointing outcomes. As such there has been increased interest in the use of higher effort physical activity and exercise as being potentially more efficacious. Though there is currently debate as to the effectiveness of public health prescription based around higher effort physical activity and exercise, most discussion around this has focused upon modes considered to be traditionally 'aerobic' (e.g. running, cycling, rowing, swimming etc.). A mode customarily performed to a relatively high intensity of effort that we believe has been overlooked is resistance training. Current guidelines do include recommendations to engage in 'muscle strengthening activities' though there has been very little emphasis upon these modes in either research or public health effort. As such the purpose of this debate article is to discuss the emerging higher effort paradigm in physical activity and exercise for public health and to make a case for why there should be a greater emphasis placed upon resistance training as a mode in this paradigm shift.

Athletes Intending to Use Sports Supplements Are More Likely to Respond to a Placebo.

PURPOSE: We investigated associations between athletes' use of sport supplements and their responsiveness to placebo and nocebo interventions. METHODS: Participants (n = 627) reported their intention to use, and actual use of, sport supplements. They then completed a 5 × 20 m repeat sprint protocol in the baseline condition, before being randomized to one of three treatments. Participants in the positive-belief treatment were administered an inert capsule described as a potent supplement which would improve sprint performance. Participants in the negative-belief treatment were administered an inert capsule described as a potent supplement which would negatively affect sprint performance. Participants in the control treatment received neither instruction nor capsule. Twenty minutes after baseline trials, all participants completed the same repeat sprint protocol in the experimental condition. RESULTS: Compared with controls, no mean differences in performance were observed between baseline and experimental conditions for the positive-belief treatment (-0.07% ± 0.27%, d = 0.02), but mean differences were observed for the negative-belief treatment (-0.92% ± 0.31%, d = 0.32), suggesting a moderate nocebo effect. In the positive-belief treatment, however, a relationship between intention to use supplements and performance was observed. Performance worsened by -1.10% ± 0.30% compared with baseline for participants not intending to use supplements, worsened by -0.64% ± 0.43% among those undecided about supplement use, but improved by 0.19% ± 0.24% among those participants intending to use supplements. CONCLUSIONS: Information about a harmful supplement worsened repeat sprint performance (a mean nocebo effect), whereas information about a beneficial supplement did not improve performance (no mean placebo effect was observed). However, participants' intention to use sport supplements influenced the direction and magnitude of subsequent placebo responses, with participants intending to use supplements more likely to respond to the positive intervention.

Quality of life in patients receiving telemedicine enhanced chronic heart failure disease management: A meta-analysis.

Background Previous reviews have investigated the effectiveness of telemedicine in the treatment of heart failure (HF). Dependent variables have included hospitalisations, mortality rates, disease knowledge and health costs. Few reviews, however, have examined the variable of health-related quality of life (QoL). Methods Randomised controlled trials comparing the delivery methods of any form of telemedicine with usual care for the provision of HF disease-management were identified via searches of all relevant databases and reference lists. Studies had to report a quantitative measure for mental, physical or overall QoL in order to be included. Results A total of 33 studies were identified. However, poor reporting of data resulted in the exclusion of seven, leaving 26 studies with 7066 participants. Three separate, random effects meta-analyses were conducted for mental, physical and overall QoL. Telemedicine was not significantly more effective than usual care on mental and physical QoL (standardised mean difference (SMD) 0.03, (95% confidence interval (CI) -0.05-0.12), p = 0.45 and SMD 0.24, (95% CI -0.08-0.56), p = 0.14, respectively). However, when compared to usual care, telemedicine was associated with a small significant increase in overall QoL (SMD 0.23, (95% CI 0.09-0.37), p = 0.001). Moderator analyses indicated that telemedicine delivered over a long-duration (≥52 weeks) and via telemonitoring was most beneficial. Conclusion Compared to usual care, telemedicine significantly increases overall QoL in patients receiving HF disease management. Statistically non-significant but nonetheless positive trends were also observed for physical QoL. These findings provide preliminary support for the use of telemedicine in the management of heart failure without jeopardising patient well-being.

Comparative effects of three 48-week community-based physical activity and exercise interventions on aerobic capacity, total cholesterol and mean arterial blood pressure.

AIM: Insufficient research examines the treatment effectiveness of real-world physical activity (PA) interventions. PURPOSE: We investigated the effects of 3 interventions on directly measured cardiovascular variables. All treatments and measures were administered in community settings by fitness centre staff. METHODS: Participants were sedentary individuals receiving no medication to reduce cardiovascular disease (CVD) risk (n=369, age 43 ±5 years). In a semirandomised design, participants were allocated to a structured gym exercise programme (STRUC), unstructured gym exercise (FREE), physical activity counselling (PAC) or a measurement-only control condition (CONT). Measures were: predicted aerobic capacity (VO2: mL kg min), mean arterial blood pressure (MAP: mm Hg) and total cholesterol (TC: mmol/L), and were taken at baseline and 48 weeks. RESULTS: Data analysis indicated a statistically significant deterioration in TC in CONT (0.8%, SD=0.5, p=0.005), and a statistically significant improvement in MAP in STRUC (2.5%, SD=8.3, p=0.004). Following a median split by baseline VO2, paired-sample t tests indicated significant improvements in VO2 among low-fit participants in STRUC (3.5%, SD=4.8, p=0.003), PAC (3.3%, SD=7.7, p=0.050) and FREE (2.6%, SD=4.8, p=0.006), and significant deterioration of VO2 among high-fit participants in FREE (-2.0%, SD=5.6, p=0.037), and PAC (-3.2%, SD=6.4, p=0.031). CONCLUSIONS: Several forms of PA may offset increased cholesterol resulting from inactivity. Structured PA (exercise) might be more effective than either unstructured PA or counselling in improving blood pressure, and community-based PA interventions might be more effective in improving VO2 among low-fit than among high-fit participants.

Is Olympic inspiration associated with fitness and physical activity in English schoolchildren? A repeated cross-sectional comparison before and 18†months after London 2012.

OBJECTIVES: To compare cardiovascular fitness and physical activity of schoolchildren 18 months after London 2012 according to Olympic 'inspiration'. DESIGN: A cross-sectional comparison between groups of schoolchildren categorised according to self-reported Olympic inspiration and a repeated cross-sectional comparison using data collected pre-2012. SETTING: Schools within a 50 km radius of the Olympic Park, Stratford, London. PARTICIPANTS: 931 students (10.0-15.9-year-olds) attending 6 schools assessed in 2013 and 2014 (18 (range: 14-20) months after London 2012) and 733 students from the same schools assessed in 2008-2009 (42 (range: 38-46) months before London 2012). PRIMARY OUTCOME MEASURES: Self-reported Olympic inspiration; cardiorespiratory fitness ([Formula: see text] mL/kg/min) assessed using the 20 m shuttle-run and self-reported physical activity. SECONDARY OUTCOMES MEASURES: Differences in [Formula: see text] before and after London 2012. RESULTS: 53% of children reported being inspired to try new sports or activities. Compared with those not inspired by the Games, [Formula: see text] was higher in boys (d=0.43) and girls (d=0.27), who continued to participate in activities at 18(14-20) months. This 45% of sample was also more physically active (boys, d=0.23; girls, d=0.38) than those not or only briefly inspired to participate in activities (boys, d=0.24; girls, d=0.21). Compared with pre-2012 values, [Formula: see text] was lower post-2012 in boys (d=0.37) and in girls (d=0.38). CONCLUSIONS: High levels of inspiration to participate in new activities reported following London 2012 and positive associations with fitness are encouraging. We cannot discount the possibility that inspired participants may have already been fitter and more active pre-2012. These associations must be interpreted in the context of the significant declines in fitness shown by our repeated cross-sectional comparison. Olympic host countries should employ longitudinal monitoring using objectively measured fitness and physical activity to provide evidence of health-related legacy.