scholarly journals Physical Activity Levels Are Low in Inoperable Lung Cancer: Exploratory Analyses from a Randomised Controlled Trial

2019 ◽  
Vol 8 (9) ◽  
pp. 1288 ◽  
Author(s):  
Lara Edbrooke ◽  
Catherine L. Granger ◽  
Ross A. Clark ◽  
Linda Denehy
Keyword(s):  
Physical Activity ◽  
Lung Cancer ◽  
Controlled Trial ◽  
Intervention Group ◽  
Stage Iv ◽  
Change Score ◽  
Quadriceps Strength ◽  
Activity Levels ◽  
Randomised Controlled

Background: In inoperable lung cancer, evidence is limited regarding physical activity (PA) and associations with other outcomes. Aims: in the usual care (UC) group of an RCT to (1) explore whether baseline PA was associated with improved follow-up outcomes, (2) identify baseline variables associated with higher follow-up PA and in all RCT participants, to (3) analyse patterns of objectively measured PA, and (4) report on characteristics of those who were able to maintain or increase PA levels. Methods: exploratory analyses of an assessor-blinded RCT. Outcomes, assessed at baseline, nine weeks and six months, included PA (seven-days of accelerometry), six-minute walk distance (6MWD), muscle strength, symptoms, mood and health-related quality of life (HRQoL). Results: 92 participants were randomised, 80 completed baseline accelerometry (39 intervention group (IG), 41 UC), characteristics: mean (SD) age 63.0 (12.3) years, 56% male, 51% stage IV disease. Baseline PA: median (IQR) steps/day 2859.6 (2034.0–3849.2) IG versus 3195.2 (2161.2–4839.0) UC. Associations between baseline PA and six-month outcomes were significant for HRQoL and 6MWD. PA at six months was significantly associated with baseline age, 6MWD and quadriceps strength. Between-group change score (steps/day) mean differences (95% CI) at nine weeks (174.5 (−1504.7 to 1853.7), p = 0.84) and six months (574.0 (−1162.3 to 2310.3), p = 0.52). Conclusions: further research is required to determine patient subgroups deriving the greatest benefits from PA interventions.

Active Classrooms: A Cluster Randomized Controlled Trial Evaluating the Effects of a Movement Integration Intervention on the Physical Activity Levels of Primary School Children

2017 ◽  
Vol 14 (4) ◽  
pp. 290-300 ◽  
Author(s):  
Rosemarie Martin ◽  
Elaine Murtagh
Keyword(s):  
Physical Activity ◽  
Primary School ◽  
School Children ◽  
Controlled Trial ◽  
Intervention Group ◽  
Primary School Children ◽  
Activity Levels ◽  
Significant Difference ◽  
Physical Activity Levels

Background:A cluster randomized controlled trial was conducted to assess the effectiveness of the Active Classrooms intervention, which integrates movement into academic lessons, on the moderate-to-vigorous physical activity levels (MVPA) of primary school children during class-time and throughout the school day.Methods:Ten classroom teachers and their students aged 8 to 12 years were recruited and randomized into the Active Classrooms intervention group (n = 131students, n = 5teachers) or a delayed-treatment controlled group (n = 117students, n = 5teachers). The intervention group participated in active academic lessons taught by the classroom teacher over an 8 week period. Accelerometers were used to gather physical activity data at baseline, postintervention and at 4 months follow-up. Teachers completed a questionnaire to evaluate the program.Results:A significant difference for change in daily class time MVPA levels was identified between the treatment (n = 95) and control (n = 91) groups from pre- to postintervention (P < .001) and this difference was maintained at follow-up (P < .001). No significant difference emerged between the treatment and control groups for change in school day MVPA levels from pre- to postintervention (P = .52) or follow-up (P = .09). Teachers reported that they were highly satisfied with the program.Conclusions:Movement integration has the potential to improve physical activity levels of primary school children in the classroom.

scholarly journals Efficacy of a Multi-Component m-Health Diet, Physical Activity, and Sleep Intervention on Dietary Intake in Adults with Overweight and Obesity: A Randomised Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2468
Author(s):  
Sasha Fenton ◽  
Tracy L. Burrows ◽  
Clare E. Collins ◽  
Anna T. Rayward ◽  
Beatrice Murawski ◽  
...  
Keyword(s):  
Physical Activity ◽  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Dietary Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Weight Loss Intervention ◽  
Traditional Group ◽  
Traditional Diet ◽  
Randomised Controlled

This three-arm randomised controlled trial evaluated whether (1) a multi-component weight loss intervention targeting diet, physical activity (PA), and sleep was effective at improving dietary intake over six months and 12 months, compared with a control, and (2) the enhanced diet, PA, and sleep intervention was more effective at improving dietary intake than the traditional diet and PA intervention. A total of 116 adults (70% female, 44.5 years, BMI 31.7 kg/m2) were randomised to either traditional diet and PA intervention; enhanced diet, PA, and sleep intervention; or wait-list control. To examine between-group differences, intervention groups were pooled and compared with the control. Then, the two intervention groups were compared. At six months, the pooled intervention group consumed 1011 fewer kilojoules/day (95% CI −1922, −101), less sodium (−313.2 mg/day; 95% CI −591.3, −35.0), and higher %EI from fruit (+2.1%EI; 95% CI 0.1, 4.1) than the controls. There were no differences in intake between the enhanced and traditional groups at six months. At 12 months, the pooled intervention and control groups reported no significant differences. However, compared to the traditional group, the enhanced reported higher %EI from nutrient-dense foods (+7.4%EI; 95% CI 1.3, 13.5) and protein (+2.4%EI; 95% CI 0.1, 4.6), and reduced %EI from fried/takeaway foods (−3.6%EI; 95% CI −6.5, −0.7), baked sweet products (−2.0%EI; 95% CI −3.6, −0.4), and packaged snacks (−1.1%EI; 95% CI −2.2, −0.3). This weight loss intervention reduced total energy and sodium intakes as well as increased fruit intake in adults at six months. The enhanced intervention group reported improved dietary intake relative to the traditional group at 12 months.

scholarly journals Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial longitudinal follow-up protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e035895
Author(s):  
Danielle Mazza ◽  
Natalie Amos ◽  
Cathy J Watson ◽  
Kevin McGeechan ◽  
Marion Haas ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Accord Study ◽  
Contraceptive Choice ◽  
Long Acting ◽  
Randomised Controlled

IntroductionThrough addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.Methods and analysisWomen participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.DiscussionDemonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.Ethics and disseminationThe ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more ‘mainstream’ strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.Trail registration numberThis trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.

scholarly journals Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016966 ◽  
Author(s):  
Sarah Thomas ◽  
Louise Fazakarley ◽  
Peter W Thomas ◽  
Sarah Collyer ◽  
Sarah Brenton ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Well Being ◽  
Recruitment Rate ◽  
Controlled Study ◽  
Activity Levels ◽  
Nintendo Wii ◽  
Serious Adverse Events ◽  
Randomised Controlled

ObjectivesWhile the health and well-being benefits of physical activity are recognised, people with multiple sclerosis (MS) often face greater barriers than the general population. The Nintendo Wii potentially offers a fun, convenient way of overcoming some of these. The aim was to test the feasibility of conducting a definitive trial of the effectiveness and cost-effectiveness of Mii-vitaliSe; a home-based, physiotherapist-supported Nintendo Wii intervention.DesignA single-centre wait-list randomised controlled study.SettingMS service in secondary care.ParticipantsAmbulatory, relatively inactive people with clinically confirmed MS.InterventionThirty participants were randomised to receive Mii-vitaliSe either immediately (for 12 months) or after a 6-month wait (for 6 months). Mii-vitaliSe consisted of two supervised Nintendo Wii familiarisation sessions in the hospital followed by home use (Wii Sports, Sports Resort and Fit Plus software) with physiotherapist support and personalised resources.OutcomesIncluded self-reported physical activity levels, quality of life, mood, self-efficacy, fatigue and assessments of balance, gait, mobility and hand dexterity at baseline, 6 and 12 months. Interviews (n=25) explored participants’ experiences and, at study end, the two Mii-vitaliSe facilitators’ experiences of intervention delivery (main qualitative findings reported separately).ResultsMean (SD) age was 49.3 (8.7) years, 90% female, with 47% diagnosed with MS <6 years ago and 60% new to active gaming. The recruitment rate was 31% (95% CI 20% to 44%). Outcome data were available for 29 (97%) at 6 months and 28 (93%) at 12 months. No serious adverse events were reported during the study. Qualitative data indicated that Mii-vitaliSe was well-received. Mean Wii use across both groups over the initial 6-month intervention period was twice a week for 27 min/day. Mean cost of delivering Mii-vitaliSe was £684 per person.DiscussionMii-vitaliSe appears acceptable and a future trial feasible and warranted. These findings will inform its design.Trial registrationISRCTN49286846

scholarly journals Effectiveness of one-to-one peer support for patients with severe mental illness – a randomised controlled trial

2017 ◽  
Vol 42 ◽  
pp. 103-110 ◽  
Author(s):  
C.I. Mahlke ◽  
S. Priebe ◽  
K. Heumann ◽  
A. Daubmann ◽  
K. Wegscheider ◽  
...  
Keyword(s):  
Mental Illness ◽  
Peer Support ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Treatment As Usual ◽  
Secondary Outcomes ◽  
One To One ◽  
Randomised Controlled

AbstractBackgroundOne-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments.MethodsThis is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years’ duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations.ResultsPatients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses.ConclusionsThe findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.

scholarly journals Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e018409 ◽  
Author(s):  
Sarah G Dean ◽  
Leon Poltawski ◽  
Anne Forster ◽  
Rod S Taylor ◽  
Anne Spencer ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cognitive Capacity ◽  
Economic Evaluations ◽  
Control Group ◽  
Rehabilitation Training ◽  
One To One ◽  
Randomised Controlled

ObjectivesTo assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity.DesignA two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations.SettingCommunity settings across two sites in Devon.ParticipantsEligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported mobility issues, no contraindications to physical activity, discharged from National Health Service or any other formal rehabilitation programme at least 1 month before, willing to be randomised to either control or ReTrain and attend the training venue, possessing cognitive capacity and communication ability sufficient to participate. Participants were individually randomised (1:1) via a computer-generated randomisation sequence minimised for time since stroke and level of functional disability. Only outcome assessors independent of the research team were blinded to group allocation.InterventionsReTrain comprised (1) an introductory one-to-one session; (2) ten, twice-weekly group classes with up to two trainers and eight clients; (3) a closing one-to-one session, followed by three drop-in sessions over the subsequent 3 months. Participants received a bespoke home-based training programme. All participants received treatment as usual. The control group received an exercise after stroke advice booklet.Outcome measuresCandidate primary outcomes included functional mobility and physical activity.ResultsForty-five participants were randomised (ReTrain=23; Control=22); data were available from 40 participants at 6 months of follow-up (ReTrain=21; Control=19) and 41 at 9 months of follow-up (ReTrain=21; Control=20). We demonstrated ability to recruit and retain participants. Participants were not burdened by the requirements of the study. We were able to calculate sample estimates for candidate primary outcomes and test procedures for process and health economic evaluations.ConclusionsAll objectives were fulfilled and indicated that a definitive trial of ReTrain is feasible and acceptable.Trial registration numberNCT02429180; Results.

scholarly journals An intervention to optimise coach-created motivational climates and reduce athlete willingness to dope (CoachMADE): a three-country cluster randomised controlled trial

2020 ◽  
pp. bjsports-2019-101963
Author(s):  
Nikos Ntoumanis ◽  
Eleanor Quested ◽  
Laurie Patterson ◽  
Stella Kaffe ◽  
Susan H Backhouse ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Trial Registration ◽  
Perceived Effectiveness ◽  
Cluster Randomised ◽  
Randomised Controlled

ObjectivesCoach-centred antidoping education is scarce. We tested the efficacy of a motivationally informed antidoping intervention for coaches, with their athletes’ willingness to dope as the primary outcome.MethodsWe delivered a cluster randomised controlled trial in Australia, the UK and Greece. This study was a parallel group, two-condition, superiority trial. Participants were 130 coaches and 919 athletes. Coaches in the intervention group attended two workshops and received supplementary information to support them in adopting a motivationally supportive communication style when discussing doping-related issues with their athletes. Coaches in the control condition attended a standard antidoping workshop that provided up-to-date information on antidoping issues yet excluded any motivation-related content. Assessments of willingness to dope (primary outcome) and other secondary outcomes were taken at baseline, postintervention (3 months) and at a 2-month follow up.ResultsCompared with athletes in the control group, athletes in the intervention group reported greater reductions in willingness to take prohibited substances (effect size g=0.17) and psychological need frustration (g=0.23) at postintervention, and greater increases in antidoping knowledge (g=0.27) at follow-up. Coaches in the intervention group reported at postintervention greater increases in efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours (g=0.45) to deal with doping-related situations. They also reported greater decreases in doping attitudes (g=0.24) and perceived effectiveness of need thwarting behaviours (g=0.35).ConclusionsAntidoping education programmes should consider incorporating principles of motivation, as these could be beneficial to coaches and their athletes. We offer suggestions to strengthen these programmes, as most of the effects we observed were not sustained at follow-up.Trial registration numberThis trial has been registered with the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371465&isReview=true).

scholarly journals Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036277 ◽  
Author(s):  
Kaushik Chattopadhyay ◽  
Pallavi Mishra ◽  
Kavita Singh ◽  
Tess Harris ◽  
Mark Hamer ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Plasma Glucose ◽  
Plasma Glucose Level ◽  
Controlled Trial ◽  
Randomised Controlled

IntroductionA huge population in India is at high risk of type-2 diabetes (T2DM). Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM. However, an unhealthy lifestyle is common among Indians. Yoga covers physical activity and a healthy diet and can help to prevent T2DM. The research question to be addressed by the main randomised controlled trial (RCT) is whether a Yoga programme for T2DM prevention (YOGA-DP) is effective in preventing T2DM among high risk people in India as compared with enhanced standard care. In this current study, we are determining the feasibility of undertaking the main RCT.InterventionYOGA-DP is a structured lifestyle education and exercise programme. The exercise part is based on Yoga and includes Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices) and Dhyana (meditation) and relaxation practices.Methods and analysisThis is a multicentre, two-arm, parallel-group, feasibility RCT with blinded outcome assessment and integrated mixed-methods process evaluation. Eligible participants should be aged 18–74 years, at high risk of T2DM (fasting plasma glucose level 5.6–6.9 mmol/L) and safe to participate in physical activities. At least 64 participants will be randomised to intervention or control group with final follow-up at 6 months. Important parameters, needed to design the main RCT, will be estimated, such as SD of the outcome measure (fasting plasma glucose level at 6-month follow-up), recruitment, intervention adherence, follow-up, potential contamination and time needed to conduct the study. Semistructured qualitative interviews will be conducted with up to 20–30 participants, a sample of those declining to participate, four YOGA-DP instructors and around eight study staff to explore their perceptions and experiences of taking part in the study and of the intervention, reasons behind non-participation, experiences of delivering the intervention and running the study, respectively.Ethics and disseminationEthics approval has been obtained from the following Research Ethics Committees: Faculty of Medicine and Health Sciences, University of Nottingham (UK); Centre for Chronic Disease Control (CCDC, India); Bapu Nature Cure Hospital and Yogashram (BNCHY, India) and Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA, India). The results will be widely disseminated among key stakeholders through various avenues.Trial registration numberCTRI/2019/05/018893.

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