Pragmatic exercise intervention in people with mild to moderate multiple sclerosis: A randomised controlled feasibility study

2013 ◽  
Vol 35 (2) ◽  
pp. 40-47 ◽  
Author(s):  
Anouska M. Carter ◽  
Amanda J. Daley ◽  
Sue W. Kesterton ◽  
Nicola M. Woodroofe ◽  
John M. Saxton ◽  
...  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Jonathan Wiles ◽  
Melanie Rees-Roberts ◽  
Jamie M. O’Driscoll ◽  
Timothy Doulton ◽  
Douglas MacInnes ◽  
...  

Abstract Background Hypertension  (HTN) affects approximately 25% of the UK population and is a leading cause of mortality. Associated annual health care costs run into billions. National treatment guidance includes initial lifestyle advice, followed by anti-hypertensive medication if blood pressure (BP) remains high. However, adoption and adherence to recommended exercise guidelines, dietary advice and anti-hypertensive medication is poor. Four short bouts of isometric exercise (IE) performed 3 days per week (d/wk) at home elicits clinically significant reductions in BP in those with normal to high-normal BP. This study will determine the feasibility of delivering personalised IE to patients with stage 1 hypertension for whom lifestyle changes would be recommended before medication within NHS primary care. Methods This is a randomised controlled feasibility study. Participants were 18+ years, with stage 1 hypertension, not on anti-hypertensive medication and without significant medical contraindications. Trial arms will be standard lifestyle advice (control) or isometric wall squat exercise and standard lifestyle advice. Primary outcomes include the feasibility of healthcare professionals to deliver isometric exercise prescriptions in a primary care NHS setting and estimation of the variance of change in systolic BP. Secondary outcomes include accuracy of protocol delivery, execution of and adherence to protocol, recruitment rate, attrition, perception of intervention viability, cost, participant experience and accuracy of home BP. The study will last 18 months. Sample size of 100 participants (50 per arm) allows for 20% attrition and 6.5% incomplete data, based upon 74 (37 each arm) participants (two-sided 95% confidence interval, width of 1.33 and standard deviation of 4) completing 4 weeks. Ethical approval IRAS ID is 274676. Discussion Before the efficacy of this novel intervention to treat stage 1 hypertension can be investigated in any large randomised controlled trial, it is necessary to ascertain if it can be delivered and carried out in a NHS primary care setting. Findings could support IE viability as a prophylactic/alternative treatment option. Trial registration ISRCTN13472393, registered 18 August 2020


2014 ◽  
Vol 20 (8) ◽  
pp. 1123-1130 ◽  
Author(s):  
J Tosh ◽  
S Dixon ◽  
A Carter ◽  
A Daley ◽  
J Petty ◽  
...  

Background: Exercise is a safe, non-pharmacological adjunctive treatment for people with multiple sclerosis but cost-effective approaches to implementing exercise within health care settings are needed. Objective: The objective of this paper is to assess the cost effectiveness of a pragmatic exercise intervention in conjunction with usual care compared to usual care only in people with mild to moderate multiple sclerosis. Methods: A cost-utility analysis of a pragmatic randomised controlled trial over nine months of follow-up was conducted. A total of 120 people with multiple sclerosis were randomised (1:1) to the intervention or usual care. Exercising participants received 18 supervised and 18 home exercise sessions over 12 weeks. The primary outcome for the cost utility analysis was the incremental cost per quality-adjusted life year (QALY) gained, calculated using utilities measured by the EQ-5D questionnaire. Results: The incremental cost per QALY of the intervention was £10,137 per QALY gained compared to usual care. The probability of being cost effective at a £20,000 per QALY threshold was 0.75, rising to 0.78 at a £30,000 per QALY threshold. Conclusion: The pragmatic exercise intervention is highly likely to be cost effective at current established thresholds, and there is scope for it to be tailored to particular sub-groups of patients or services to reduce its cost impact.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rachel Lowe ◽  
Christy Barlow ◽  
Barry Lloyd ◽  
Julie Latchem-Hastings ◽  
Vincent Poile ◽  
...  

Abstract The LEAP-MS (Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis) study has developed an individualised supported self-management approach for physical activity for people with progressive multiple sclerosis (MS) and severe disability. The intervention has been evaluated in a single-arm feasibility study with embedded process evaluation. The feasibility study was due to open to recruitment during the COVID-19 2020–2021 pandemic, 1 month into the first UK-wide lockdown. We worked rapidly to implement adaptions to the trial procedures and intervention delivery that we believe are applicable to randomised controlled trials. Recruitment became predominantly via self-referral. Electronic consent was employed, with consent discussions occurring over the telephone. Registration, consent, eligibility assessment and data collection as well as the intervention (online physical activity tool) were via a secure, encrypted multi-user web-based platform for participants, physiotherapists and researchers accessible via various hardware. Physiotherapy consultations, as well as the process evaluation, were conducted remotely using video conferencing software or the telephone. A remote training package for physiotherapists and site initiations was also developed and electronic site files employed. Our adaptions are extremely topical given the COVID-19 situation, and whilst not what we had originally planned, have enabled successful delivery of the feasibility study and are relevant to conducting randomised controlled trials and meeting the needs of people with MS who are far more isolated than ever before. Trial registration ClinicalTrials.govNCT03951181. Registered on 15 May 2019.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Saïd Ibeggazene ◽  
Rebecca Turner ◽  
Derek Rosario ◽  
Liam Bourke

Abstract Background The COVID-19 pandemic has forced many cancer services to consider a transition to a remote format of delivery that is largely untested. Accordingly, we sought to perform a systematic review of the effects of remotely delivered interventions to improve exercise behaviour in sedentary adults living with and beyond cancer. Methods Eligible studies were randomised controlled trials comparing a remotely delivered exercise intervention to a usual care comparison in sedentary people over 18 years old with a primary cancer diagnosis. Nine electronic databases were searched from inception to November 2020. Results The review included three trials, totalling 186 participants. Two of the included trials incorporated prescriptions that meet current aerobic exercise recommendations, one of which also meets the guidelines for resistance exercise. No trials reported an intervention adherence of 75% or more for a set prescription that meets current exercise guidelines. Conclusion There is little evidence suggesting that remote exercise interventions promote exercise behaviours or improve physical function in sedentary adults living with and beyond cancer. The development and evaluation of novel remote exercise interventions is needed to establish their usefulness for clinical practice. Given the social response to the COVID-19 pandemic, further research in this area is urgently needed.


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