scholarly journals Buddy-Motivational Interviewing (buddy-MI) to Increase Physical Activity in Community Settings: Study Protocol for a Pragmatic Randomised Controlled Trial

2013 ◽  
Vol 1 (2) ◽  
pp. 6-14 ◽  
Author(s):  
David Brinson ◽  
Mark Wallace-Bell ◽  
Ray Kirk ◽  
Andrew Hornblow
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Motivational Interviewing ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Great Difficulty ◽  
Community Settings ◽  
Parallel Group ◽  
Randomised Controlled

This article describes the development and evaluation of a novel buddy-motivational interviewing intervention intended to help apparently healthy but relatively sedentary adults to adopt and maintain regular physical activity for health and fitness. Many people experience great difficulty in initiating physical activity (“the getting going problem”) and behavioural regression is common (“the keeping it going problem”). Typically there is a rather large gap between what people know to be healthy and what they actually do. This intervention is an adaptation of motivational interviewing in that it adds client-selected motivational-buddies who can provide in-session input as well as ongoing out-of-session support focused on strengthening clients’ motivation for and movement toward their physical activity goals. A pragmatic parallel group randomised controlled trial with 12-month follow-up aims to deliver and assess the effectiveness of the intervention in a format that could realistically be implemented within primary care, workplaces, schools or other similar setting. The study is due to report clinical effectiveness findings in 2014.

scholarly journals Buddy-motivational interviewing (buddy-MI) to Increase Physical Activity in Community Settings: Results of a Pragmatic Randomised Controlled Trial

2015 ◽  
Vol 1 (3) ◽  
pp. 31-37
Author(s):  
David Brinson ◽  
Mark Wallace-Bell ◽  
Ray Kirk ◽  
Andrew Hornblow
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Motivational Interviewing ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Control Group ◽  
Ripple Effects ◽  
Parallel Group ◽  
Development Evaluation ◽  
Randomised Controlled

This article describes the implementation and evaluation of a novel buddy-Motivational Interviewing intervention intended to help apparently healthy but relatively sedentary adults to adopt and maintain regular physical activity for health and fitness. This intervention is an adaptation of Motivational Interviewing which adds client-selected motivational-buddies who can provide in-session input as well as ongoing out-of-session support focused on strengthening client’s motivation for and movement toward their physical activity goals. A pragmatic parallel-group randomised controlled trial with 12-month follow-up was implemented to test the intervention. The trial demonstrated that buddy-MI was feasible and could be delivered with equivalent fidelity to standard MI and both groups demonstrated statistically significant changes across a range of behavioural and health-status outcomes. Moreover, the experimental group participants generally ‘outperformed’ the control group participants as shown by the consistent trends observed over three repeated measures out to 12-months (although these between-group differences were statistically non-significant). Qualitative data indicated participant acceptance of the programme as well as providing initial evidence of positive collateral health effects (‘ripple effects’ whereby buddies changed their behaviours also). Consideration for further development, evaluation and applications are also discussed.

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 Different suturing techniques in thoracic incision: protocol for a feasibility randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e021645
Author(s):  
Zonghui Liu ◽  
Xiangyu Liu ◽  
Lin He ◽  
Xueyuan Yu ◽  
Lu Wang ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Costal Cartilage ◽  
Clinical Effectiveness ◽  
Suture Technique ◽  
Skin Closure ◽  
Mattress Suture ◽  
Vertical Mattress ◽  
Randomised Controlled

IntroductionBased on the principles of the ideal skin closure technique, we previously described a suture technique (wedge-shaped excision and modified buried vertical mattress suture (WE-MBVMS)) that could provide excellent outcomes for the most demanding surfaces. However, adequate clinical comparative evidence supporting improved outcomes is lacking. Thus, the purpose of this protocol is to establish the feasibility of conducting a fully randomised controlled trial (RCT) comparing the clinical effectiveness of WE-MBVMS with a buried intradermal suture (BIS) in closing thoracic incision.Methods and analysisThis study is a feasibility RCT of WE-MBVMS and BIS in patients undergoing surgery for costal cartilage harvesting. Seventy-eight participants are expected to participate in the study and will be randomised in a ratio of 1:1 to WE-MBVMS or BIS. Trial feasibility will be assessed by the number of participants assessed for eligibility, recruitment rates, reasons for ineligibility or non-participation, time for interventions, withdrawal and retention at all follow-up points (3, 6 and 12 months), follow-up rates and reasons for withdrawing from the trial. In addition, clinical data regarding the cosmetic results of scars will be collected to inform the sample size for a fully powered RCT.Ethics and disseminationThis study has been approved by The First Affiliated Hospital of Xi’an Jiaotong University Institutional Review Board (XJTU1AF2017LSK-120). The findings will be published in peer-reviewed journals.Trial registration numberChiCTR-INR-17013335; Pre-results.

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.

scholarly journals Impact of assessment and intervention by a health and social care professional team in the emergency department on the quality, safety, and clinical effectiveness of care for older adults: A randomised controlled trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (7) ◽  
pp. e1003711
Author(s):  
Marica Cassarino ◽  
Katie Robinson ◽  
Dominic Trépel ◽  
Íde O’Shaughnessy ◽  
Eimear Smalle ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Length Of Stay ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Early Assessment ◽  
Health And Social Care ◽  
Randomised Controlled

Background Older adults frequently attend the emergency department (ED) and experience high rates of adverse events following ED presentation. This randomised controlled trial evaluated the impact of early assessment and intervention by a dedicated team of health and social care professionals (HSCPs) in the ED on the quality, safety, and clinical effectiveness of care of older adults in the ED. Methods and findings This single-site randomised controlled trial included a sample of 353 patients aged ≥65 years (mean age = 79.6, SD = 7.01; 59.2% female) who presented with lower urgency complaints to the ED a university hospital in the Mid-West region of Ireland, during HSCP operational hours. The intervention consisted of early assessment and intervention carried out by a HSCP team comprising a senior medical social worker, senior occupational therapist, and senior physiotherapist. The primary outcome was ED length of stay. Secondary outcomes included rates of hospital admissions from the ED; hospital length of stay for admitted patients; patient satisfaction with index visit; ED revisits, mortality, nursing home admission, and unscheduled hospital admission at 30-day and 6-month follow-up; and patient functional status and quality of life (at index visit and follow-up). Demographic information included the patient’s gender, age, marital status, residential status, mode of arrival to the ED, source of referral, index complaint, triage category, falls, and hospitalisation history. Participants in the intervention group (n = 176) experienced a significantly shorter ED stay than the control group (n = 177) (6.4 versus 12.1 median hours, p < 0.001). Other significant differences (intervention versus control) included lower rates of hospital admissions from the ED (19.3% versus 55.9%, p < 0.001), higher levels of satisfaction with the ED visit (p = 0.008), better function at 30-day (p = 0.01) and 6-month follow-up (p = 0.03), better mobility (p = 0.02 at 30 days), and better self-care (p = 0.03 at 30 days; p = 0.009 at 6 months). No differences at follow-up were observed in terms of ED re-presentation or hospital admission. Study limitations include the inability to blind patients or ED staff to allocation due to the nature of the intervention, and a focus on early assessment and intervention in the ED rather than care integration following discharge. Conclusions Early assessment and intervention by a dedicated ED-based HSCP team reduced ED length of stay and the risk of hospital admissions among older adults, as well as improving patient satisfaction. Our findings support the effectiveness of an interdisciplinary model of care for key ED outcomes. Trial registration ClinicalTrials.gov NCT03739515; registered on 12 November 2018.

scholarly journals Maintenance of physical activity level, functioning and health after non-pharmacological treatment of pelvic girdle pain with either transcutaneous electrical nerve stimulation or acupuncture: a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e046314
Author(s):  
Annika Svahn Ekdahl ◽  
Monika Fagevik Olsén ◽  
Tove Jendman ◽  
Annelie Gutke
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Nerve Stimulation ◽  
Transcutaneous Electrical Nerve Stimulation ◽  
Controlled Trial ◽  
Pelvic Girdle ◽  
Pelvic Girdle Pain ◽  
Electrical Nerve Stimulation ◽  
Randomised Controlled

ObjectiveTo investigate if there are differences between acupuncture and transcutaneous electrical nerve stimulation (TENS) as treatment for pelvic girdle pain (PGP) in pregnancy in order to manage pain and thus maintain health and functioning in daily activities and physical activity (PA).DesignRandomised controlled trial.Setting and participantsPregnant women (n=113) with clinically verified PGP in gestational weeks 12–28, recruited from maternity healthcare centres, randomised (1:1) into two groups. Exclusion criteria: any obstetrical complication, systemic disease or previous disorder that could contradict tests or treatment.InterventionsThe intervention consisted of either 10 acupuncture sessions (two sessions per week) provided by a physiotherapist or daily home-based TENS during 5 weeks.Primary outcome variablesDisability (Oswestry Disability Index), functioning (Patient Specific Functional Scale), work ability (Work Ability Index) and PA-level according to general recommendations.Secondary outcome variablesFunctioning related to PGP (Pelvic Girdle Questionnaire), evening pain intensity (Numeric Rating Scale, NRS), concern about pain (NRS), health (EuroQoL 5-dimension), symptoms of depression/catastrophising (Edinburgh Postnatal Depression Scale/Coping Strategies Questionnaire).ResultsNo mean differences were detected between the groups. Both groups managed to preserve their functioning and PA level at follow-up. This may be due to significantly (p<0.05) reduced within groups evening pain intensity; acupuncture −0.96 (95% CI −1.91 to −0.01; p=0.049), TENS −1.29 (95% CI −2.13 to −0.44; p=0.003) and concern about pain; acupuncture −1.44 (95% CI −2.31 to −0.57; p=0.0012), TENS −1.99 (95% CI −2.81 to −1.17; p<0.0001). The acupuncture group showed an improvement in functioning at follow-up; 0.82 (95% CI 0.01 to 1.63; p=0.048)ConclusionTreating PGP with acupuncture or TENS resulted in maintenance of functioning and physical activity and also less pain and concern about pain. Either intervention could be recommended as a non-pharmacological alternative for pain relief and may enable pregnant women to stay active.Trial registration number12726. https://www.researchweb.org/is/sverige/project/127261

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