Combining technology and research to prevent scald injuries: results from Cool Runnings randomised controlled trial (Preprint)

BACKGROUND New technologies, widespread availability of the internet, the rise of social media and increased ownership of smartphones provide new opportunities for health researchers to communicate and engage with target audiences. OBJECTIVE This new technology was used to recruit mothers of young children to a smartphone application (app) to increase their knowledge about childhood burns (specifically hot beverage scalds) and correct burn first-aid. This six-month intervention deployed on the Cool Runnings app, used gamification techniques to reinforce intervention messages and engage participants. METHODS A two-group, parallel, single blinded, randomized controlled trial (RCT) to evaluate the efficacy of a smartphone app-based burn prevention intervention. Participants were women aged 18+, living in Queensland, Australia, with at least one child aged 5-12 months at the time of enrolment. The primary outcome measure was change in knowledge around burn risk and correct burn first-aid assessed via two methods: overall score; and categorised as adequate (score =4) vs inadequate (score less than 4). The secondary outcome measure was the efficacy of gamification techniques (measured by: app opens, photo uploads, pop quiz completions and content views). RESULTS In total, 498 participants were recruited via social media and enrolled. At 6-month follow-up, 244 participants completed the post-test questionnaire. Attrition rates in both groups were similar. Participants who remained in the study did not differ from those who were lost to follow up on any characteristics except for education level. Although similar at baseline, intervention group participants achieved significantly greater improvement in overall knowledge post-test than control group participants on both primary outcome measures (overall knowledge intervention: mean=2.68± 1.00 vs control mean:2.13±1.03; intervention: 20.47% adequate vs control: 7.3%). Consequently, the NNT was 7.46. Logistic regression showed participants exposed to the highest level of disadvantage were 7.3 times more likely to improve overall knowledge scores than participants in other levels of disadvantage. There were also significant correlations between each of the four gamification techniques and knowledge change (p<0.001). In addition, participants with low/moderate ‘app activity’ were 8.59 times more likely to have improved knowledge between baseline and 6-month follow-up than those who had no app activity (95%CI=2.9-25.02); participants with high app activity were 18.26 times more likely to have improved knowledge (95%CI=7.1-46.8). CONCLUSIONS Despite substantial loss to follow-up, this RCT demonstrates the Cool Runnings app was an effective intervention for improving knowledge about hot beverage scald risks and burn first-aid in mothers of young children. The benefits of combining gamification elements in the intervention were also highlighted. Given the low cost and large reach of smartphone apps to deliver content to, and engage with targeted populations, results from this RCT provides important information on how smartphone applications can be used for widespread injury prevention campaigns, and public health campaigns generally. CLINICALTRIAL This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000019404)

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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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Neoadjuvant cryotherapy improves dysphagia and may impact remission rates in advanced esophageal cancer

Endoscopy International Open ◽

10.1055/a-0957-2798 ◽

2019 ◽

Vol 07 (11) ◽

pp. E1522-E1527 ◽

Cited By ~ 1

Author(s):

Tilak Shah ◽

Vladimir Kushnir ◽

Pritesh Mutha ◽

Mankanchan Majhail ◽

Bhaumik Patel ◽

...

Keyword(s):

Esophageal Cancer ◽

Advanced Cancer ◽

Primary Outcome ◽

Outcome Measure ◽

Synergistic Effects ◽

Locally Advanced ◽

Secondary Outcome ◽

Secondary Outcome Measure ◽

Dysphagia Score ◽

Locally Advanced Cancer

Abstract Background and study aims Liquid nitrogen spray cryotherapy (LNSC) can provide rapid dysphagia relief, and is postulated to stimulate a local antitumor immune response. The aim of this prospective pilot clinical trial was to evaluate the safety and efficacy of LNSC when administered prior to chemoradiotherapy. Patients and methods Treatment-naïve adult patients with dysphagia at the time of biopsy-proven squamous carcinoma or adenocarcinoma of the esophagus were prospectively enrolled at two tertiary medical centers. Patients underwent a single session of LNSC. The primary outcome measure was change in dysphagia at 1 and 2 weeks post-cryotherapy. A secondary outcome measure was clinical complete response rate (CR) following chemoradiotherapy. Results Twenty-five patients were screened, of whom 21 patients were eligible and enrolled. There were seven with metastatic and 14 with locally advanced cancer. The primary outcome of dysphagia improvement of ≥ 1 point occurred in 15/21 patients (71 %) at 1 week, and 10/20 patients (50 %) at 2 weeks. The median dysphagia score improved by 1 at 1 week (P = 0.0003), and 0.5 at 2 weeks (P = 0.02). Six of nine patients (67 %) with locally advanced cancer who completed chemoradiation did not have residual tumor cells on mucosal biopsy, and five of nine patients (56 %) had a clinical CR. There were no serious cryotherapy-related complications. Conclusions LNSC provided safe and effective palliation for esophageal cancer patients who presented with dysphagia at index diagnosis. Its combination with chemoradiotherapy did not lead to any serious toxicity. Our study provides a scientific rationale for pursuing larger clinical trials addressing synergistic effects of combining LNSC with chemoradiation.

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Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette’s disorder: a pilot randomised controlled trial with long-term follow-up

BMJ Open ◽

10.1136/bmjopen-2018-024685 ◽

2019 ◽

Vol 9 (2) ◽

pp. e024685 ◽

Cited By ~ 17

Author(s):

Per Andrén ◽

Kristina Aspvall ◽

Lorena Fernández de la Cruz ◽

Paulina Wiktor ◽

Sofia Romano ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Young People ◽

Primary Outcome ◽

Outcome Measure ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Behaviour Therapy ◽

Tic Severity ◽

Randomised Controlled

ObjectiveBehaviour therapy (BT) for Tourette’s disorder (TD) and persistent (chronic) motor or vocal tic disorder (PTD) is rarely available. We evaluated the feasibility of adapting two existing BT protocols for TD/PTD (habit reversal training (HRT) and exposure and response prevention (ERP)) into a therapist-guided and parent-guided online self-help format.DesignA pilot, single-blind, parallel group randomised controlled trial.SettingA specialist outpatient clinic in Sweden.ParticipantsTwenty-three young people with TD/PTD, aged 8–16.InterventionsTwo 10-week therapist-guided and parent-guided internet-delivered programmes (called BIP TIC HRT and BIP TIC ERP).OutcomeThe primary outcome measure was the Yale Global Tic Severity Scale. Blinded evaluators rated symptoms at baseline, post-treatment and 3-month follow-up (primary endpoint). All participants were naturalistically followed up to 12 months after treatment.ResultsPatients and parents rated the interventions as highly acceptable, credible and satisfactory. While both interventions resulted in reduced tic-related impairment, parent-rated tic severity and improved quality of life, only BIP TIC ERP resulted in a significant improvement on the primary outcome measure. Within-group effect sizes and responder rates were, respectively: d=1.12 and 75% for BIP TIC ERP, and d=0.50 and 55% for BIP TIC HRT. The therapeutic gains were maintained up to 12 months after the end of the treatment. Adverse events were rare in both groups. The average therapist support time was around 25 min per participant per week.ConclusionsInternet-delivered BT has the potential to greatly increase access to evidence-based treatment for young people with TD/PTD. Further evaluation of the efficacy and cost-effectiveness of this treatment modality is warranted.Trial registration numberNCT02864589; Pre-results.

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The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2016-015111 ◽

2017 ◽

Vol 7 (8) ◽

pp. e015111 ◽

Cited By ~ 3

Author(s):

Mohamed Abdel-Fattah ◽

Graeme MacLennan ◽

Mary Kilonzo ◽

R Phil Assassa ◽

Kirsty McCormick ◽

...

Keyword(s):

Primary Outcome ◽

Outcome Measure ◽

Single Incision ◽

Controlled Trial ◽

Primary Outcome Measure ◽

Female Stress Urinary Incontinence ◽

Midurethral Slings ◽

Secondary Outcomes ◽

Randomised Controlled

IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.Methods and analysisA pragmatic, multicentre, non-inferiority randomised controlled trial.Primary outcome measureThe primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months.Secondary outcome measuresThe secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit.Statistical analysisThe statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly.Ethics and disseminationThe North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations.Trial registration numberISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.

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Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial

BMJ ◽

10.1136/bmj.m4903 ◽

2021 ◽

pp. m4903

Author(s):

James O’Hara ◽

Deborah D Stocken ◽

Gillian C Watson ◽

Tony Fouweather ◽

Julian McGlashan ◽

...

Keyword(s):

Confidence Interval ◽

Proton Pump Inhibitors ◽

Proton Pump ◽

Primary Outcome ◽

Outcome Measure ◽

Randomised Trial ◽

Secondary Outcome ◽

Secondary Outcome Measure ◽

Double Blind ◽

Significant Difference

Abstract Objective To assess the use of proton pump inhibitors (PPIs) to treat persistent throat symptoms. Design Pragmatic, double blind, placebo controlled, randomised trial. Setting Eight ear, nose, and throat outpatient clinics, United Kingdom. Participants 346 patients aged 18 years or older with persistent throat symptoms who were randomised according to recruiting centre and baseline severity of symptoms (mild or severe): 172 to lansoprazole and 174 to placebo. Intervention Random blinded allocation (1:1) to either 30 mg lansoprazole twice daily or matched placebo twice daily for 16 weeks. Main outcome measures Primary outcome was symptomatic response at 16 weeks measured using the total reflux symptom index (RSI) score. Secondary outcomes included symptom response at 12 months, quality of life, and throat appearances. Results Of 1427 patients initially screened for eligibility, 346 were recruited. The mean age of the study sample was 52.2 (SD 13.7) years, 196 (57%) were women, and 162 (47%) had severe symptoms at presentation; these characteristics were balanced across treatment arms. The primary analysis was performed on 220 patients who completed the primary outcome measure within a window of 14-20 weeks. Mean RSI scores were similar between treatment arms at baseline: lansoprazole 22.0 (95% confidence interval 20.4 to 23.6) and placebo 21.7 (20.5 to 23.0). Improvements (reduction in RSI score) were observed in both groups—score at 16 weeks: lansoprazole 17.4 (15.5 to19.4) and placebo 15.6 (13.8 to 17.3). No statistically significant difference was found between the treatment arms: estimated difference 1.9 points (95% confidence interval −0.3 to 4.2 points; P=0.096) adjusted for site and baseline symptom severity. Lansoprazole showed no benefits over placebo for any secondary outcome measure, including RSI scores at 12 months: lansoprazole 16.0 (13.6 to 18.4) and placebo 13.6 (11.7 to 15.5): estimated difference 2.4 points (−0.6 to 5.4 points). Conclusions No evidence was found of benefit from PPI treatment in patients with persistent throat symptoms. RSI scores were similar between the lansoprazole and placebo groups after 16 weeks of treatment and at the 12 month follow-up. Trial registration ISRCTN Registry ISRCTN38578686 and EudraCT 2013-004249-17.

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Prognostic value of reduction in left atrial size during a follow-up of heart failure: an observational study

BMJ Open ◽

10.1136/bmjopen-2020-044409 ◽

2021 ◽

Vol 11 (2) ◽

pp. e044409

Author(s):

Masayuki Shiba ◽

Takao Kato ◽

Takeshi Morimoto ◽

Hidenori Yaku ◽

Yasutaka Inuzuka ◽

...

Keyword(s):

Heart Failure ◽

Lower Risk ◽

Left Atrial ◽

Primary Outcome ◽

Outcome Measure ◽

No Reduction ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Group Change

ObjectiveThe association between sequential changes in left atrial diameter (LAD) and prognosis in heart failure (HF) remains to be elucidated. The present study aimed to investigate the link between reduction in LAD and clinical outcomes in patients with HF.DesignA multicentre prospective cohort study.SettingThis study was nested from the Kyoto Congestive Heart Failure registry including consecutive patients admitted for acute decompensated heart failure (ADHF) in 19 hospitals throughout Japan.ParticipantsThe current study population included 673 patients with HF who underwent both baseline and 6-month follow-up echocardiography with available paired LAD data. We divided them into two groups: the reduction in the LAD group (change <0 mm) (n=398) and the no-reduction in the LAD group (change ≥0 mm) (n=275).Primary and secondary outcomesThe primary outcome measure was a composite of all-cause death or hospitalisation for HF during 180 days after 6-month follow-up echocardiography. The secondary outcome measures were defined as the individual components of the primary composite outcome measure and a composite of cardiovascular death or hospitalisation for HF.ResultsThe cumulative 180-day incidence of the primary outcome measure was significantly lower in the reduction in the LAD group than in the no-reduction in the LAD group (13.3% vs 22.2%, p=0.002). Even after adjusting 15 confounders, the lower risk of reduction in LAD relative to no-reduction in LAD for the primary outcome measure remained significant (HR 0.59, 95% CI 0.36 to 0.97 p=0.04).ConclusionPatients with reduction in LAD during follow-up after ADHF hospitalisation had a lower risk for a composite endpoint of all-cause death or HF hospitalisation, suggesting that the change of LAD might be a simple and useful echocardiographic marker during follow-up.

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Randomized Controlled Trial Comparing the Efficacy and Safety of Epidural Infiltration of Particulate Versus Nonparticulate Steroids in the Treatment of Patients with Sciatic Pain

International Journal of Innovative Research in Medical Science ◽

10.23958/ijirms/vol06-i12/1306 ◽

2021 ◽

Vol 6 (12) ◽

pp. 911-914

Author(s):

Nazia Nazir ◽

Savita Gupta ◽

Vikas Saxena

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Radicular Pain ◽

Functional Improvement ◽

Secondary Outcome ◽

Methylprednisolone Acetate ◽

Dexamethasone Phosphate ◽

To Receive ◽

Corticosteroid Injections

Introduction: Epidural corticosteroid injections are widely used to treat low back pain, but doubts exist about the relative efficacy of particulate versus non-particulate corticosteroids. Epidural corticosteroid injections were performed in 75 patients with chronic radicular pain were evaluated for epidural corticosteroid injections to determine if there was a difference in the efficacy of triamcilone acetate, methylprednisolone acetate, and dexamethasone. Methods: 75 patients presenting with debilitating radicular pain were randomized to receive an injection of triamcilone acetate 40 mg/ml, methylprednisolone acetate 40 mg/ml, and dexamethasone phosphate 7.5 mg/ml at equal doses. Data were collected at 1-month and 3-month follow-up. The primary outcome of the present study was reduction in pain on a visual analog scale (VAS) at 3 months, while the secondary outcome was the type and number of complications in the study group. Results: Regardless of baseline score VAS, pain score decreased in all patients at one and three months. The patients with VAS of very severe also showed a statistically significant success rate at one and three month follow-up [p= 0.043]. No serious complications occurred in all three groups. Conclusion: According to this study, pain relief and functional improvement are similar among all three methylprednisolone acetate, triamcilone acetate and dexamethasone phosphate at 3 months.

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Effect of Individually Tailored Biopsychosocial Workplace Interventions on Chronic Musculoskeletal Pain and Stress Among Laboratory Technicians: Randomized Controlled Trial

January 2018 - Pain Physician ◽

10.36076/ppj.2015/18/459 ◽

2015 ◽

Vol 5;18 (5;9) ◽

pp. 459-471 ◽

Cited By ~ 4

Author(s):

Kenneth Jay

Keyword(s):

Pain Intensity ◽

Musculoskeletal Pain ◽

Outcome Measure ◽

Chronic Musculoskeletal Pain ◽

Secondary Outcome ◽

Body Region ◽

Response Analysis ◽

Secondary Outcome Measure ◽

Randomized Controlled

Background: Chronic musculoskeletal pain is prevalent among laboratory technicians and work-related stress may aggravate the problem. Objectives: This study investigated the effect of a multifaceted worksite intervention on pain and stress among laboratory technicians with chronic musculoskeletal pain using individually tailored physical and cognitive elements. Study Design: This trial uses a single-blind randomized controlled design with allocation concealment in a 2-armed parallel group format among laboratory technicians. The trial “Implementation of physical exercise at the Workplace (IRMA09) – Laboratory technicians“ was registered at ClinicalTrials.gov prior to participant enrolment. Setting: The study was conducted at the head division of a large private pharmaceutical company’s research and development department in Denmark. The study duration was March 2014 (baseline) to July 2014 (follow-up). Methods: Participants (n = 112) were allocated to receive either physical, cognitive, and mindfulness group-based training (PCMT group) or a reference group (REF) for 10 weeks at the worksite. PCMT consisted of 4 major elements: 1) resistance training individually tailored to the pain affected area, 2) motor control training, 3) mindfulness, and 4) cognitive and behavioral therapy/education. Participants of the REF group were encouraged to follow ongoing company health initiatives. The predefined primary outcome measure was pain intensity (VAS scale 0 – 10) in average of the regions: neck, shoulder, lower and upper back, elbow, and hand at 10 week follow-up. The secondary outcome measure was stress assessed by Cohen´s perceived stress questionnaire. In addition, an explorative dose-response analysis was performed on the adherence to PCMT with pain and stress, respectively, as outcome measures. Results: A significant (P < 0.0001) treatment by time interaction in pain intensity was observed with a between-group difference at follow-up of -1.0 (95%CI: -1.4 to -0.6). No significant effect on stress was observed (treatment by time P = 0.16). Exploratory analyses for each body region separately showed significant pain reductions of the neck, shoulders, upper back and lower back, as well as a tendency for hand pain. Within the PCMT group, general linear models adjusted for age, baseline pain, and stress levels showed significant associations for the change in pain with the number of physical-cognitive training sessions per week (-0.60 [95%CI -0.95 to -0.25]) and the number of mindfulness sessions (0.15 [95%CI 0.02 to 0.18]). No such associations were found with the change in stress as outcome. Limitations: Limitations of behavioral interventions include the inability to blind participants to which intervention they receive. Self-reported outcomes are a limitation as they may be influenced by placebo effects and outcome expectations

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Hypokalemia Measurement and Management in Patients With Status Asthmaticus on Continuous Albuterol

Hospital Pediatrics ◽

10.1542/hpeds.2021-006265 ◽

2022 ◽

Author(s):

Courtney Cox ◽

Krishna Patel ◽

Rebecca Cantu ◽

Chary Akmyradov ◽

Katherine Irby

Keyword(s):

Potassium Level ◽

Primary Outcome ◽

Pediatric Patients ◽

Status Asthmaticus ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Secondary Outcome Measure ◽

Treatment Frequency ◽

Care Costs

OBJECTIVE: Status asthmaticus is commonly treated in pediatric patients by using continuous albuterol, which can cause hypokalemia. The primary aim of this study was to determine if serial potassium monitoring is necessary by examining treatment frequency of hypokalemia. METHODS: This retrospective analysis was performed in 185 pediatric patients admitted with status asthmaticus requiring continuous albuterol between 2017 and 2019. All patients were placed on intravenous fluids containing potassium. The primary outcome measure was the treatment of hypokalemia in relation to the number of laboratory draws for potassium levels. The secondary outcome measure was hypokalemia frequency and relation to the duration and initial dose of continuous albuterol. RESULTS: Included were 156 patients with 420 laboratory draws (average, 2.7 per patient) for potassium levels. The median lowest potassium level was 3.40 mmol/L (interquartile range, 3.2–3.7). No correlation was found between initial albuterol dose and lowest potassium level (P = .52). Patients with hypokalemia had a mean albuterol time of 12.32 (SD, 15.76) hours, whereas patients without hypokalemia had a mean albuterol time of 11.50 (SD, 12.53) hours (P = .29). Potassium levels were treated 13 separate times. CONCLUSIONS: The number of laboratory draws for potassium levels was high in our cohort, with few patients receiving treatment for hypokalemia beyond the potassium routinely added to maintenance fluids. Length of time on albuterol and dose of albuterol were not shown to increase the risk of hypokalemia. Serial laboratory measurements may be decreased to potentially reduce health care costs, pain, and anxiety surrounding needlesticks.

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Effects of Pilates-Based Core Stability Training in Ambulant People With Multiple Sclerosis: Multicenter, Assessor-Blinded, Randomized Controlled Trial

Physical Therapy ◽

10.2522/ptj.20150166 ◽

2016 ◽

Vol 96 (8) ◽

pp. 1170-1178 ◽

Cited By ~ 27

Author(s):

Esther E. Fox ◽

Alan D. Hough ◽

Siobhan Creanor ◽

Margaret Gear ◽

Jennifer A. Freeman

Keyword(s):

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Confidence Interval ◽

Outcome Measure ◽

Controlled Trial ◽

Exercise Group ◽

Core Stability ◽

Secondary Outcome ◽

Secondary Outcome Measure ◽

Randomized Controlled

Abstract Background Pilates exercise is often undertaken by people with multiple sclerosis (MS) who have balance and mobility difficulties. Objectives The primary aim of the study was to compare the effects of 12 weeks of Pilates exercises with relaxation on balance and mobility. Secondary aims were: (1) to compare standardized exercises with relaxation and (2) to compare Pilates exercises with standardized exercises. Methods A multicenter, assessor-blinded, randomized controlled trial was conducted. Participants with Expanded Disability Status Scale scores of 4.0 to 6.5 were randomly allocated to groups receiving 12 weeks of Pilates exercises, standardized exercises, or relaxation. Assessments were undertaken at baseline and weeks 12 and 16 (primary outcome measure: 10-Meter Timed Walk Test [10MTW]). Results One hundred participants (mean age=54 years, 74% female) were randomized to study groups. Six participants relapsed (withdrew from the study), leaving 94 participants for intention-to-treat analysis. There was no significant difference in mean 10MTW measurements between the Pilates and relaxation groups. At 12 weeks, there was a mean reduction of 4.2 seconds for the standardized exercise group compared with the relaxation group (95% confidence interval [relaxation group minus standardized exercise group measurements]=0.0, 8.4) and a mean reduction of 3.7 seconds for the Pilates group compared with the standardized exercise group (95% confidence interval [Pilates group minus standardized exercise group measurements]=−0.4 to 7.8). At 16 weeks, mean 10MTW times for the standardized exercise group remained quicker than those for the Pilates and relaxation groups, although the differences were nonsignificant. There were no significant differences between the Pilates and relaxation groups for any secondary outcome measure. Limitations In this study, therapists were limited to a standardized basket of exercises that may have affected the study outcomes. Furthermore, choosing measures such as posturography to assess balance, accelerometry to assess walking, or a specific trunk assessment scale might have been more responsive in detecting changes in outcome. Conclusion Participants did not improve significantly, either in the short term or at the 4-week follow-up, on the 10MTW after 12 weeks of Pilates exercises compared with 12 weeks of relaxation.

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