Exercise training and physiological responses to acute stress: study protocol and methodological considerations of a randomised controlled trial

BackgroundThis paper describes the protocol and methodological prerequisites for a randomised controlled exercise intervention. Selected baseline data from the study are also presented, demonstrating some methodological challenges related to exercise intervention trials. The aim of the trial was to study the effects of exercise training on physiological responses to acute psychosocial stress in untrained individuals.MethodsIndividuals with a low level of physical activity were invited to participate in an exercise intervention lasting for 6 months. A total of 119 participants were included and went through a peak oxygen uptake test and a psychosocial stress test at baseline. Adrenocorticotropic hormone (ACTH) and cortisol were measured in connection to the stress test to identify the physiological response.ResultsAlmost 90% of the participants reported themselves as untrained, but results from the objectively measured oxygen uptake did not seem to correspond to the reported sedentary lifestyle. The primary outcome measures at baseline varied between individuals. The mean change from pre-test to peak value was 214% for ACTH and 94% for cortisol. Of these, 13 individuals did not respond in ACTH and/or and cortisol.DiscussionSupposedly untrained individuals seeking participation in an exercise intervention might not be as untrained as they report, a methodological consideration of importance when evaluating the effects of training. Another important consideration is related to the primary outcome measure, which should be measurable and possible to affect. Absence of reaction at baseline means that changes can only be detected as an increased reaction.

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The effects of exercise training on hypothalamic-pituitary-adrenal axis reactivity and autonomic response to acute stress—a randomized controlled study

Trials ◽

10.1186/s13063-020-04803-3 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Elin Arvidson ◽

Anna Sjörs Dahlman ◽

Mats Börjesson ◽

Lennart Gullstrand ◽

Ingibjörg H. Jonsdottir

Keyword(s):

Exercise Training ◽

Oxygen Uptake ◽

Psychosocial Stress ◽

Acute Stress ◽

Stress Test ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Acute Psychosocial Stress

Abstract Background Exercise training is suggested to have a stress-buffering effect on physiological reactions to acute stress. The so-called cross-stressor adaptation hypothesis is one of many theories behind the plausible effects, proposing that the attenuated physiological reaction seen in trained individuals in response to acute exercise is also seen when the individual is exposed to acute psychosocial stress. However, few randomized controlled trials (RCT) are available in this field. Therefore, the aim of the present trial was to study the effects of a 6-month aerobic exercise intervention on the physiological response to acute laboratory stress. Methods A two-armed RCT including untrained but healthy individuals aged 20–50 years was conducted. Assessments included a peak oxygen uptake test and a psychosocial stress test (the Trier Social Stress Test). A total of 88 participants went through both baseline and follow-up measures (48 in the intervention group and 40 in the control group) with a similar proportion of women and men (20 women and 28 men in the intervention group and 18 women and 22 men in the control group). Outcome measures were adrenocorticotrophic hormone, cortisol, systolic and diastolic blood pressure, and heart rate responses to acute psychosocial stress. Results Oxygen uptake and time-to-exhaustion increased significantly following the intervention, while a decrease was seen in the control group. The analyses showed attenuated responses to acute psychosocial stress for all variables in both groups at follow-up, with no differences between the groups. No correlation was seen between amount of exercise training and reactivity to the stress test. Despite the increased oxygen uptake in the intervention group, no differences were seen between the groups for any of the outcome variables at follow-up. Conclusions In this study, the cross-stressor adaptation hypothesis could not be confirmed. Both groups showed decreased reactions indicating a habituation to the stress test. Trial registration ClinicalTrials.gov NCT02051127. Registered on 31 January 2014—retrospectively registered.

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Bladder cancer and exeRcise trAining during intraVesical thErapy—the BRAVE trial: a study protocol for a prospective, single-centre, phase II randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2021-055782 ◽

2021 ◽

Vol 11 (9) ◽

pp. e055782

Author(s):

Fernanda Z. Arthuso ◽

Adrian S. Fairey ◽

Normand G. Boulé ◽

Kerry S. Courneya

Keyword(s):

Bladder Cancer ◽

Randomised Controlled Trial ◽

Exercise Training ◽

Patient Reported Outcomes ◽

Exercise Intervention ◽

Controlled Trial ◽

Intravesical Therapy ◽

Patient Reported ◽

Health Related ◽

Randomised Controlled

IntroductionNon-muscle invasive bladder cancer (NMIBC) accounts for about 75% of newly diagnosed bladder cancers. The treatment for NMIBC involves surgical removal of the tumour followed by 6 weekly instillations of immunotherapy or chemotherapy directly into the bladder (ie, intravesical therapy). NMIBC has a high rate of recurrence (31%–78%) and progression (15%). Moreover, bladder cancer and its treatment may affect patient functioning and quality of life. Exercise is a safe and effective intervention for many patient with cancer groups, however, no studies have examined exercise during intravesical therapy for NMIBC. The primary objective of the Bladder cancer and exeRcise trAining during intraVesical thErapy (BRAVE) trial is to examine the safety and feasibility of an exercise intervention in patients with bladder cancer undergoing intravesical therapy. The secondary objectives are to investigate the preliminary efficacy of exercise on health-related fitness and patient-reported outcomes; examine the social cognitive predictors of exercise adherence; and explore the potential effects of exercise on tumour recurrence and progression.Methods and analysisBRAVE is a phase II randomised controlled trial that aims to include 66 patients with NMIBC scheduled to receive intravesical therapy. Participants will be randomly assigned to the exercise intervention or usual care. The intervention consists of three supervised, high-intensity interval training sessions per week for 12 weeks. Feasibility will be evaluated by eligibility, recruitment, adherence and attrition rates. Preliminary efficacy will focus on changes in cardiorespiratory fitness and patient-reported outcomes from baseline (prior to intravesical therapy) to pre-cystoscopy (3 months). Cancer outcomes will be tracked at 3 months, and 1-year follow-up by cystoscopy. Analysis of covariance will compare between-group differences at post-intervention (pre-cystoscopy) for all health-related fitness and patient-reported outcomes.Ethics and disseminationThe study was approved by the Health Research Ethics Board of Alberta-Cancer Committee (#20–0184). Dissemination will include publication and presentations at scientific conferences and public channels.Trial registration numberNCT04593862; Pre-results.

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Impressions of using the Cohen-Mansfield Agitation Inventory as an outcome measure: Lessons learnt for future clinical researchers (innovative practice)

Dementia ◽

10.1177/1471301217695910 ◽

2017 ◽

Vol 19 (2) ◽

pp. 464-471 ◽

Cited By ~ 2

Author(s):

Lindsey Brett ◽

Victoria Traynor ◽

Shahla Meedya ◽

Paul Stapley

Keyword(s):

Primary Outcome ◽

Exercise Intervention ◽

Outcome Measure ◽

Small Sample Size ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Small Sample ◽

Clinical Settings ◽

Randomised Controlled ◽

Hawthorn Effect

The Cohen-Mansfield Agitation Inventory was a tool originally developed for use in research to measure agitation and subsequently used in clinical settings. It was the primary outcome measure for a randomised controlled trial which evaluated the effects and feasibility of a physiotherapist-led physical exercise intervention on agitation and physical performance of individuals living with dementia in nursing homes. The study produced weak results in regards to the Cohen-Mansfield Agitation Inventory due to small sample size and perceived issues with the use of the Cohen-Mansfield Agitation Inventory. Therefore, the focus of this paper is consideration of the identified issues by the research team: learnt effect and Hawthorn effect, misunderstanding of behaviours and inaccurate recall and observation. It is important that tools originally developed for research are still valid and reliable in the clinical setting.

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Oral insulin immunotherapy in children at risk for type 1 diabetes in a randomised controlled trial

Diabetologia ◽

10.1007/s00125-020-05376-1 ◽

2021 ◽

Author(s):

Robin Assfalg ◽

Jan Knoop ◽

Kristi L. Hoffman ◽

Markus Pfirrmann ◽

Jose Maria Zapardiel-Gonzalo ◽

...

Keyword(s):

Immune Response ◽

Type 1 Diabetes ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Antibody Responses ◽

Oral Insulin ◽

Cell Responses ◽

Randomised Controlled

Abstract Aims/hypothesis Oral administration of antigen can induce immunological tolerance. Insulin is a key autoantigen in childhood type 1 diabetes. Here, oral insulin was given as antigen-specific immunotherapy before the onset of autoimmunity in children from age 6 months to assess its safety and immune response actions on immunity and the gut microbiome. Methods A phase I/II randomised controlled trial was performed in a single clinical study centre in Germany. Participants were 44 islet autoantibody-negative children aged 6 months to 2.99 years who had a first-degree relative with type 1 diabetes and a susceptible HLA DR4-DQ8-containing genotype. Children were randomised 1:1 to daily oral insulin (7.5 mg with dose escalation to 67.5 mg) or placebo for 12 months using a web-based computer system. The primary outcome was immune efficacy pre-specified as induction of antibody or T cell responses to insulin and measured in a central treatment-blinded laboratory. Results Randomisation was performed in 44 children. One child in the placebo group was withdrawn after the first study visit and data from 22 insulin-treated and 21 placebo-treated children were analysed. Oral insulin was well tolerated with no changes in metabolic variables. Immune responses to insulin were observed in children who received both insulin (54.5%) and placebo (66.7%), and the trial did not demonstrate an effect on its primary outcome (p = 0.54). In exploratory analyses, there was preliminary evidence that the immune response and gut microbiome were modified by the INS genotype Among children with the type 1 diabetes-susceptible INS genotype (n = 22), antibody responses to insulin were more frequent in insulin-treated (72.7%) as compared with placebo-treated children (18.2%; p = 0.03). T cell responses to insulin were modified by treatment-independent inflammatory episodes. Conclusions/interpretation The study demonstrated that oral insulin immunotherapy in young genetically at-risk children was safe, but was not associated with an immune response as predefined in the trial primary outcome. Exploratory analyses suggested that antibody responses to oral insulin may occur in children with a susceptible INS genotype, and that inflammatory episodes may promote the activation of insulin-responsive T cells. Trial registration Clinicaltrials.gov NCT02547519 Funding The main funding source was the German Center for Diabetes Research (DZD e.V.) Graphical abstract

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Effects of a low‐dose Copenhagen adduction exercise intervention on adduction strength in sub‐elite male footballers: A randomised controlled trial

Translational Sports Medicine ◽

10.1002/tsm2.238 ◽

2021 ◽

Cited By ~ 1

Author(s):

Jack Dawkins ◽

Lasse Ishøi ◽

Jake O. Willott ◽

Lars L. Andersen ◽

Kristian Thorborg

Keyword(s):

Randomised Controlled Trial ◽

Low Dose ◽

Exercise Intervention ◽

Controlled Trial ◽

Randomised Controlled

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Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-021-01133-8 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Russell Jago ◽

Byron Tibbitts ◽

Kathryn Willis ◽

Emily Sanderson ◽

Rebecca Kandiyali ◽

...

Keyword(s):

Physical Activity ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Cluster Randomised ◽

Secondary Outcomes ◽

Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

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Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol

BMJ Open ◽

10.1136/bmjopen-2018-026086 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026086

Author(s):

Yasutake Tomata ◽

Fumiya Tanji ◽

Dieta Nurrika ◽

Yingxu Liu ◽

Saho Abe ◽

...

Keyword(s):

Financial Incentives ◽

Primary Outcome ◽

Financial Incentive ◽

Controlled Trial ◽

Intervention Group ◽

Sample Size Calculation ◽

Community Dwelling ◽

Control Group ◽

Modifiable Factors ◽

Randomised Controlled

IntroductionPhysical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan.Methods and analysisThis study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4–6 weeks and 7–9 weeks) relative to the average number of daily steps at the baseline (1–3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps.Ethics and disseminationThis study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal.Trial registration numberUMIN000033276; Pre-results.

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Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.117.198630 ◽

2017 ◽

Vol 211 (2) ◽

pp. 95-102 ◽

Cited By ~ 13

Author(s):

Patricia Cooney ◽

Catherine Jackman ◽

David Coyle ◽

Gary O'Reilly

Keyword(s):

Intellectual Disability ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Outcome Measure ◽

Controlled Trial ◽

Behavioural Therapy ◽

Primary Outcome Measure ◽

Cognitive Behavioural ◽

Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

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