scholarly journals A feasibility randomised controlled trial of short-term fasting prior to CAPOX chemotherapy for stage 2/3 colorectal cancer: SWiFT protocol

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Ellie Shingler ◽  
Claire Perks ◽  
Georgia Herbert ◽  
Andy Ness ◽  
Charlotte Atkinson
Keyword(s):  
Colorectal Cancer ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Trial Registration ◽  
Secondary Outcome ◽  
Dietary Advice ◽  
Short Term ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Capecitabine and oxaliplatin (CAPOX) chemotherapy is a standard treatment for stage 2/3 colorectal cancer. Treatment is associated with dose-limiting toxicities such as neutropenia, vomiting, diarrhoea, and stomatitis. Short-term fasting prior to chemotherapy may help protect normal cells from the toxic effects of chemotherapy by allowing them to conserve energy for maintenance and repair. However, there is a lack of evidence to support the efficacy of short-term fasting in protecting against chemotherapy-related toxicities in humans, and it is not known whether people due to undergo chemotherapy will be willing and able to follow a short-term fast. Preliminary data confirming this is feasible are required before adequately powered trials can be designed and conducted. Methods The short-term, water only, fasting trial (SWiFT) is a two-armed feasibility randomised controlled trial, aiming to recruit 30 people scheduled to begin routine treatment with CAPOX chemotherapy for stage 2/3 colorectal cancer. Participants will be randomly allocated, in a 1:1 ratio, to either a 36-h fast or standard dietary advice prior to chemotherapy administration for the first 3 cycles of chemotherapy. The primary outcome measures will assess the feasibility of the trial and include: adherence to intervention, recruitment, retention, and data completion rates as well as the acceptability of the intervention which will be qualitatively assessed. The secondary outcome measures aim to provide further information on possible outcomes of interest for a definitive trial and include side effects of chemotherapy, quality of life, markers of cellular metabolism and inflammation, appetite, and sarcopenia. Discussion It is not known whether it is possible to recruit to a trial of short-term fasting in this population, or whether participants would be able to adhere to the intervention. Therefore, we aim to test the feasibility of a pre-chemotherapy, 36-h, water-only fast in people receiving CAPOX chemotherapy for stage 2/3 colorectal cancer. Trial registration This trial has been registered with the ISRCTN Registry. Trial registration no: ISRCTN17994717. Date of registration: 23 October 2018. URL: http://www.isrctn.com/ISRCTN17994717

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Comparison of efficacy and safety between electroacupuncture at ‘four sacral points’ and conventional electroacupuncture for the treatment of urinary incontinence after stroke: study protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e021783 ◽  
Author(s):  
Shan Chen ◽  
Siyou Wang ◽  
Lihua Xuan ◽  
Hanti Lu ◽  
Zhikai Hu ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Randomised Controlled Trial ◽  
Medical Care ◽  
Outcome Measures ◽  
Pudendal Nerve ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Routine Medical Care ◽  
Randomised Controlled

IntroductionElectroacupuncture at ‘four sacral points’, also known as electrical pudendal nerve stimulation therapy, combines the advantages of pudendal nerve neuromodulation and the technique of deep insertion of long acupuncture needles. It has been used to treat stress urinary incontinence, female urgency-frequency syndrome, idiopathic urgency urinary incontinence and neurological bladders in previous studies. Here, we describe the protocol for a randomised controlled trial for evaluation of the efficacy and safety of electroacupuncture at ‘four sacral points’ for the management of urinary incontinence after stroke.Methods and analysisThis is an open-label randomised controlled trial with blinded assessments and analyses. A total of 140 eligible patients will be randomly allocated to two groups. The treatment group (n=70) will receive electroacupuncture at ‘four sacral points’ along with routine medical care, while the control group will receive conventional electroacupuncture along with routine medical care. Twenty treatment sessions will occur over a period of 4 weeks. The primary outcome measures will be the self-recorded findings in an incontinent episode diary at baseline and at 4 weeks after baseline. The secondary outcome measures will be the International Consultation on Incontinence Questionnaire Urinary Incontinence—Short Form (ICIQ-UI SF) score and the Barthel Activities of Daily Living Index (Barthel ADL Index) score at baseline and at 4 and 28 weeks after baseline.Ethics and disseminationThis protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059–01). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.Trial registration numberChiCTR-IOR-17012847; Pre-result.

Effects of golf training on cognition in older adults: a randomised controlled trial

2018 ◽  
Vol 72 (10) ◽  
pp. 944-950 ◽  
Author(s):  
Hiroyuki Shimada ◽  
Sangyoon Lee ◽  
Masahiro Akishita ◽  
Koichi Kozaki ◽  
Katsuya Iijima ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Training Group ◽  
Community Dwelling ◽  
Secondary Outcome ◽  
Control Group ◽  
Logical Memory ◽  
Randomised Controlled

BackgroundAlthough research indicates that a physically active lifestyle has the potential to prevent cognitive decline and dementia, the optimal type of physical activity/exercise remains unclear. The present study aimed to determine the cognitive benefits of a golf-training programme in community-dwelling older adults.MethodsWe conducted a randomised controlled trial between August 2016 and June 2017 at a general golf course. Participants included 106 Japanese adults aged 65 and older. Participants were randomly assigned to either a 24-week (90–120 min sessions/week) golf-training group or a health education control group. Postintervention changes in Mini-mental State Examination (MMSE) and National Centre for Geriatrics and Gerontology-Functional Assessment Tool scores were regarded as primary outcome measures. Secondary outcome measures included changes in physical performance and Geriatric Depression Scale (GDS) scores.ResultsA total of 100 participants (golf training, n=53; control, n=47) completed the assessments after the 24-week intervention period. The adherence to the golf programme was 96.2% (51/53 participants). Analysis using linear mixed models revealed that the golf training group exhibited significantly greater improvements in immediate logical memory (p=0.033), delayed logical memory (p=0.009) and composite logical memory (p=0.013) scores than the control group. However, no significant changes in MMSE, word memory, Trail Making Test or Symbol Digital Substitution Test scores were observed. In addition, no significant changes in grip strength, walking speed or GDS were observed.ConclusionsGolf-based exercise interventions may improve logical memory in older adults, but no significant changes in other cognitive tests. Further follow-up investigations are required to determine whether the observed effects are associated with delayed onset of mild cognitive impairment or Alzheimer’s disease in older adults.Trial registration numberUMIN-CTR UMIN000024797; Pre-results.

scholarly journals Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Meg Wiggins ◽  
Mary Sawtell ◽  
Octavia Wiseman ◽  
Christine McCourt ◽  
Sandra Eldridge ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Antenatal Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Trial Registration ◽  
Secondary Outcome ◽  
The World ◽  
Randomised Controlled

Abstract Background Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. Methods The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a ‘healthy baby’ composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born “healthy” in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional ‘healthy and positive birth’ of the intervention with standard care. Qualitative data will be analysed thematically. Discussion This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. Trial registration Trial registration; ISRCTN, ISRCTN91977441. Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.

scholarly journals Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL ABC): feasibility randomised controlled trial protocol

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Jana Sremanakova ◽  
Anne Marie Sowerbutts ◽  
Chris Todd ◽  
Richard Cooke ◽  
Sorrel Burden
Keyword(s):  
Physical Activity ◽  
Colorectal Cancer ◽  
Randomised Controlled Trial ◽  
Behaviour Change ◽  
Healthy Eating ◽  
Controlled Trial ◽  
Bowel Cancer ◽  
Active Lifestyle ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Targeting modifiable lifestyle factors including diet and physical activity represents a potentially cost-effective strategy that could support a growing population of colorectal cancer survivors and improve their health outcomes. Currently, effective, evidence-based interventions and resources helping people after bowel cancer to adopt new lifestyle habits are lacking. The aim of this trial is to test the Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL-ABC) intervention to inform a future definitive randomised controlled trial. Methods/design This is a feasibility randomised controlled trial. A total of 72 survivors who have completed surgery and all anticancer treatments will be recruited. The intervention group will receive HEAL-ABC resources based on behaviour change theory combined with supportive telephone calls informed by motivational interviewing every 2 weeks during the 3-month intervention, and once a month for 6 months to follow-up. Participants in the control group will follow usual care and have access to resources available in the public domain. The study is testing feasibility of the intervention including adherence and ability to collect data on anthropometry, body composition, diet, physical activity, behaviour change, quality of life, blood markers, contact with healthcare services, morbidities and overall survival. Discussion The proposed study will add to the evidence base by addressing an area where there is a paucity of data. This study on lifestyle interventions for people after colorectal cancer follows the Medical Research Council guidance on evaluating complex interventions in clinical practice. It focuses on people living after treatment for colorectal cancer and targets an important research area identified by cancer survivors as a research priority reported by the National Cancer Institute and James Lind Alliance UK. Trial registration ClinicalTrials.gov NCT04227353 approved on the 13th of January 2020

scholarly journals Rehabilitation nursing for motor functional recovery of acute ischaemic stroke: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e037391
Author(s):  
Jianmiao Wang ◽  
Yuanyuan Chen ◽  
Yuping Zhang ◽  
Mei Li ◽  
Jingfen Jin
Keyword(s):  
Randomised Controlled Trial ◽  
Ischaemic Stroke ◽  
Outcome Measures ◽  
Functional Recovery ◽  
Acute Ischaemic Stroke ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Functional Impairments ◽  
Randomised Controlled

IntroductionStroke is the second-leading cause of death and disability in the world, and patients with stroke often suffer from functional impairments and need rehabilitation. Notably, there is much evidence that rehabilitation can lead to better mortality and morbidity outcomes. The evidence for the effectiveness of rehabilitation nursing, however, is limited. Thus, this study seeks to explore whether rehabilitation nursing is not inferior to usual rehabilitation for motor functional recovery in patients with acute ischaemic stroke.Methods and analysisWe will conduct an assessor-blinded parallel randomised controlled trial of patients who meet the inclusion criteria after stratification by weighted corticospinal tract lesion load. The experimental group will receive rehabilitation nursing by trained and qualified nurses (seven consecutive days, two sessions per day, 30 min each session). The control group will receive usual rehabilitation provided by therapists (seven consecutive days, two sessions per day, 30 min each session). The primary outcome measures are the Motor Assessment Scale, the Fugl-Meyer Assessment and the Action Research Arm Test. The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale. Primary and secondary outcome assessment will be performed before and after the intervention, and secondary outcome be assessed at 4 and 12 weeks follow-up. We will recruit 224 patients within a period of 12–18 months from a hospital in southeastern China.Ethics and disseminationThe study was approved by the Human Research Ethics Committee from the corresponding author’s hospital (approval Number is Ethical Review Study No. 2018 - 112). Peer-reviewed journals and presentations at national and international conferences will be used to disseminate the results.Trial registration numberNCT03702452.

scholarly journals Impact of a “vegetables first” approach to complementary feeding on later intake and liking of vegetables in infants: a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jeanette P. Rapson ◽  
Pamela R. von Hurst ◽  
Marion M. Hetherington ◽  
Cathryn A. Conlon
Keyword(s):  
New Zealand ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Complementary Feeding ◽  
Iron Status ◽  
Controlled Trial ◽  
Fruit And Vegetables ◽  
Trial Registration ◽  
Randomised Control Trial ◽  
Randomised Controlled

Abstract Background Vegetables as first complementary foods for infants may programme taste preferences that lead to improved vegetable intake in children. Yet few studies have investigated the impact of a ”vegetables first” approach to complementary feeding, especially in New Zealand. The purpose of this randomised control trial is to investigate the effect of starting complementary feeding with vegetables only on infants’ later intake and liking of vegetables, compared to those starting with fruit and vegetables. Methods/design One-hundred and twenty mother-infant pairs living in Auckland, New Zealand, will be randomised to receive either vegetables only (intervention) or fruit and vegetables (control) for 28 days, starting from the first day of complementary feeding at around 4–6 months of age. Infants will be presented with a brassica (broccoli), followed by a green leafy vegetable (spinach) and sweet fruit (pear) at 9 months of age. The primary outcome measures of intake of each food will be assessed using a weighed food diary. Secondary outcome measures of overall intake, liking and wanting of vegetables will be assessed using a food frequency questionnaire, liking tool and video coding tool, respectively, at 9, 12, and 24 months of age. Infant growth and iron status will be assessed as part of health screening and monitoring at baseline, post intervention and 9 months of age. Other biological samples to be collected include infant stool samples, vitamin D (mother and infant), iron status (mother), and mothers’ diet. Discussion This randomised, controlled trial will be the first to our knowledge to investigate a “vegetables first” approach to complementary feeding on infants’ liking and intake of vegetables in New Zealand. Comparison against standard practice (fruit and vegetables as first foods) should complement other trials underway, such as the Baby’s First Bites and Nordic OTIS trial. Results may contribute to the evidence supporting complementary feeding guidelines in New Zealand and worldwide. Trial registration Australian New Zealand Clinical Trial Registry ACTRN12619000737134. Registered on 16 May 2019.

scholarly journals Protocol to evaluate the impact of yoga supplementation on cognitive function in schizophrenia: a randomised controlled trial

2014 ◽  
Vol 26 (5) ◽  
pp. 280-290 ◽  
Author(s):  
Triptish Bhatia ◽  
Sati Mazumdar ◽  
Nagendra Narayan Mishra ◽  
Raquel E. Gur ◽  
Ruben C. Gur ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Clinical Severity ◽  
Secondary Outcome ◽  
Daily Functioning ◽  
Beneficial Effects ◽  
Living Skills ◽  
Randomised Controlled

BackgroundSchizophrenia (SZ) is a chronic illness that is treated symptomatically. Cognitive dysfunction is a core feature of SZ that is relatively intractable to pharmacotherapy. Yoga can improve cognitive function among healthy individuals. A recent open trial indicated significant benefits of yoga training (YT) in conjunction with conventional pharmacotherapy among patients with SZ.AimsTo describe the protocol for an ongoing randomised controlled trial designed to test whether the reported beneficial effects of YT on cognitive function among SZ patients can be replicated. Secondarily, the effects of YT on daily functioning living skills are evaluated.MethodsConsenting patients with SZ receive routine clinical treatment and are randomised to adjunctive YT, adjunctive physical exercise (PE) or treatment as usual (proposed N = 234 total, N = 78 in each group). The trial involves YT or PE 5 days a week and lasts 3 weeks. Participants are evaluated thrice over 6 months. Cognitive functions measured by Trail Making Test, University of Pennsylvania Neurocognitive Computerised Battery were primary outcome measures while clinical severity and daily functioning measured by Independent Living Skills Survey were secondary outcome measures.ResultsA total of 309 participants have been randomised as of 31 August 2013, which exceeded beyond 294 proposed after attrition. Once participants begin YT or PE they generally complete the protocol. No injuries have been reported.ConclusionsShort term YT is feasible and acceptable to Indian SZ patients. If beneficial effects of YT are detected, it will provide a novel adjunctive cognitive remediation strategy for SZ patients.

scholarly journals Short-term weight gain among preschool children in rural Burkina Faso: a secondary analysis of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029634 ◽  
Author(s):  
Elena G Dennis ◽  
Ali Sie ◽  
Lucienne Ouermi ◽  
Clarisse Dah ◽  
Charlemagne Tapsoba ◽  
...  
Keyword(s):  
Weight Gain ◽  
Randomised Controlled Trial ◽  
Food Insecurity ◽  
Burkina Faso ◽  
Controlled Trial ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Short Term ◽  
Randomised Controlled ◽  
Socioeconomic And Demographic Factors

ObjectivesNutrition has profound effects on children’s health outcomes and is linked to weight gain and cognitive development. We used data from a randomised controlled trial to evaluate the prospective associations between dietary, socioeconomic and demographic factors and short-term weight gain during the lean season in a rural area of Burkina Faso.DesignProspective cohort data arising from a randomised controlled trial of the effect of antibiotic distribution on child growth and intestinal microbial diversity.SettingTwo rural communities in Nouna District, Burkina Faso.Participants246 children aged 6–59 months living in the study communities were enrolled in the study.Primary and secondary outcome measuresAnthropometric measurements, including weight and height, were obtained at baseline and 1 month.ResultsOf 246 children, the median weight for wasted children at baseline (weight-for-height z-score <−2) was 9.7 kg (IQR 8.65–10.8) and the weight of non-wasted children was 12.8 kg (IQR 10.9–14.75). Food insecurity was significantly associated with decreased weight gain velocity (mean difference −0.03 g/kg/day, 95% CI −0.06 to −0.006, p=0.04).ConclusionExperiences of household food insecurity before the beginning of the lean season were associated with decreased weight gain in children in rural Burkina Faso during the lean season, although the mean difference was small. Understanding the relationship between timing of food insecurity and anthropometric outcomes may help to develop policies and health programme that address both of these issues.Trial registration numberNCT03187834.

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