scholarly journals Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis (LEAP-MS): adaptions during the COVID-19 pandemic and remote delivery for improved efficiency

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rachel Lowe ◽  
Christy Barlow ◽  
Barry Lloyd ◽  
Julie Latchem-Hastings ◽  
Vincent Poile ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Process Evaluation ◽  
Feasibility Study ◽  
Randomised Controlled Trials ◽  
Progressive Multiple Sclerosis ◽  
Management Approach ◽  
Controlled Trials ◽  
Link Type ◽  
Randomised Controlled

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.

scholarly journals Lifestyle, exercise and activity package for people living with progressive multiple sclerosis (LEAP-MS): protocol for a single-arm feasibility study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Julie Latchem-Hastings ◽  
Elizabeth Randell ◽  
Kate Button ◽  
Fiona Jones ◽  
Rachel Lowe ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Process Evaluation ◽  
Feasibility Study ◽  
Progressive Multiple Sclerosis ◽  
Self Management ◽  
Link Type ◽  
Physiotherapy Intervention ◽  
Home Based

Abstract Background We have co-designed a tailored blended physiotherapy intervention for people with progressive multiple sclerosis (PwPMS) who often struggle to access support for physical activity. Underpinned by self-management principles, the Lifestyle, Exercise and Activity Package for people with Multiple Sclerosis (LEAP-MS) intervention incorporates face-to-face or online physiotherapy coaching sessions with an accompanying online physical activity platform. The LEAP-MS platform is a multi-user system enabling user and physiotherapist to co-create activity plans. The LEAP-MS platform consists of an information and activity suite, interactive components enabling selection of exercises into an activity programme, goal setting and activity logging. The platform also facilitates online remote support from a physiotherapist through an embedded online messaging function. We aim to evaluate the LEAP-MS platform in a feasibility trial. Methods LEAP-MS will be evaluated within a single-arm feasibility study with embedded process evaluation. After registration and initial eligible screening, 21 participants will be required to complete baseline self-completion measures. This will be followed by an initial home-based or online coaching session with a physiotherapist (who has received tailored self-management and digital resource training) and access to the online intervention for an initial 3-month period. During this period, participants are given the option to request up to five further home-based or online physiotherapy coaching sessions. Follow-up questionnaires and semi-structured interviews will be administered 3 months after baseline with participants and intervention physiotherapists. The LEAP-MS platform will be available to participants for a further 3 months. Usage of the LEAP-MS platform will be tracked during the full 6-month period and final follow-up will be conducted 6 months after baseline. Discussion Feasibility outcomes (recruitment, retention, intervention uptake and safety) will be reported. The process evaluation will be undertaken to identify possible mechanisms for any observed effects. The data will inform full-scale evaluations of this co-produced, blended physiotherapy intervention. Trial registration ClinicalTrials.gov, NCT03951181. Registered 15 May 2019

scholarly journals Lifestyle, exercise and activity package for people living with progressive multiple sclerosis (LEAP-MS): Protocol for a Single-Arm Feasibility Study.

2020 ◽  
Author(s):  
Julie Latchem-Hastings ◽  
Elizabeth Randell ◽  
Kate Button ◽  
Fiona Jones ◽  
Rachel Lowe ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Process Evaluation ◽  
Feasibility Study ◽  
Progressive Multiple Sclerosis ◽  
Feasibility Trial ◽  
Self Management ◽  
Physiotherapy Intervention ◽  
Home Based

Abstract Background. We have co-designed a tailored blended physiotherapy intervention for people with Progressive Multiple Sclerosis (MS) who often struggle to access support for physical activity. Underpinned by self-management principles, the Lifestyle, Exercise and Activity Package for people with MS intervention, which we call the LEAP-MS intervention, incorporates face-to-face or online physiotherapy coaching sessions with an accompanying online physical activity platform. The LEAP-MS platform is a multi-user system enabling user and physiotherapist to co-create activity plans. The LEAP-MS platform consists of an information and activity suite, interactive components enabling selection of exercises into an activity programme, goal setting, and activity logging. The platform also facilitates online remote support from a physiotherapist through an embedded online messaging function. We aim to evaluate the LEAP-MS platform in a feasibility trial. Methods. LEAP-MS will be evaluated within a single arm feasibility study with embedded process evaluation. After registration and initial eligible screening, 21 participants will be required to complete baseline self-completion measures. This will be followed by an initial home-based or online coaching session with a physiotherapist (who has received tailored self-management and digital resource training) and access to the online intervention for an initial three-month period. During this period participants are given the option to request up to five further home-based or online physiotherapy coaching sessions. Follow-up questionnaires and semi-structured interviews will be administered three months after baseline with participants and intervention physiotherapists. The LEAP-MS platform will be available to participants for a further three months. Usage of the LEAP-MS platform will be tracked during the full six-month period and final follow up will be conducted six months after baseline. Discussion. Feasibility outcomes (recruitment, retention, intervention uptake and safety) will be reported. The process evaluation will be undertaken to identify possible mechanisms for any observed effects. The data here will inform full scale evaluations of this co-produced, blended physiotherapy intervention. Trial registration: ClinicalTrials.gov NCT03951181. Registered 15th May 2019 https://clinicaltrials.gov/ct2/show/NCT03951181

Motivational interviewing to promote health outcomes and behaviour change in multiple sclerosis: a systematic review

2019 ◽  
Vol 34 (3) ◽  
pp. 299-309 ◽  
Author(s):  
Diana S. Dorstyn ◽  
Jane L. Mathias ◽  
Charles H. Bombardier ◽  
Amanda J. Osborn
Keyword(s):  
Multiple Sclerosis ◽  
Health Outcomes ◽  
Motivational Interviewing ◽  
Randomised Controlled Trials ◽  
Data Extraction ◽  
Progressive Multiple Sclerosis ◽  
Controlled Trials ◽  
Rehabilitation Care ◽  
Mean Differences ◽  
Randomised Controlled

Objective: To examine the evidence for motivational interviewing when used to assist individuals with multiple sclerosis manage their healthcare. Data sources: The Cochrane, Embase, PsycINFO and PubMed databases were searched for studies published between 1983 and December 2019. The reference lists of included studies were additionally examined and Scopus citation searches conducted. Review methods: Study screening and data extraction were independently completed by two reviewers. Randomised controlled trials comparing motivational interviewing interventions for multiple sclerosis to usual care, wait-list or other active intervention controls were examined. Studies were assessed using the Cochrane Risk of Bias tool. Standardised mean differences (Hedges’ g), 95% confidence intervals and P values were calculated for all health and behavioural outcomes. Results: Ten randomised controlled trials, involving a pooled sample of 987 adults with relapsing–remitting or progressive multiple sclerosis and mild to moderate impairment, were identified. Most trials had a low or unclear risk of methodological bias. Motivational interviewing, when used in conjunction with other counselling or rehabilitation techniques, resulted in significant immediate medium-to-very large improvements in multiple physical, psychological, social and behavioural outcomes (range: g = .34–2.68). Maintenance effects were promising (range: g = .41–1.11), although less frequently assessed ( Nstudies = 5) and of limited duration (1–7 months). Individual and group-based interventions, delivered in-person or by telephone, were all effective. Conclusions: Motivational interviewing is a flexible counselling technique that may improve rehabilitation care for multiple sclerosis. However, evidence for persisting benefits to health outcomes and behaviour is currently limited.

scholarly journals Explaining temporal trends in annualised relapse rates in placebo groups of randomised controlled trials in relapsing multiple sclerosis: systematic review and meta-regression

2013 ◽  
Vol 19 (12) ◽  
pp. 1580-1586 ◽  
Author(s):  
Simon M Steinvorth ◽  
Christian Röver ◽  
Simon Schneider ◽  
Richard Nicholas ◽  
Sebastian Straube ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Eligibility Criteria ◽  
Patient Age ◽  
Meta Regression ◽  
Randomised Controlled ◽  
Relapsing Multiple Sclerosis ◽  
Relapse Rates ◽  
Over Time

Background: Recent studies have shown a decrease in annualised relapse rates (ARRs) in placebo groups of randomised controlled trials (RCTs) in relapsing multiple sclerosis (RMS). Methods: We conducted a systematic literature search of RCTs in RMS. Data on eligibility criteria and baseline characteristics were extracted and tested for significant trends over time. A meta-regression was conducted to estimate their contribution to the decrease of trial ARRs over time. Results: We identified 56 studies. Patient age at baseline ( p < 0.001), mean duration of multiple sclerosis (MS) at baseline ( p = 0.048), size of treatment groups ( p = 0.003), Oxford Quality Scale scores ( p = 0.021), and the number of eligibility criteria ( p<0.001) increased significantly, whereas pre-trial ARR ( p = 0.001), the time span over which pre-trial ARR was calculated ( p < 0.001), and the duration of placebo-controlled follow-up ( p = 0.006) decreased significantly over time. In meta-regression of trial placebo ARR, the temporal trend was found to be insignificant, with major factors explaining the variation: pre-trial ARR, the number of years used to calculate pre-trial ARR and study duration. Conclusion: The observed decline in trial ARRs may result from decreasing pre-trial ARRs and a shorter time period over which pre-trial ARRs were calculated. Increasing patient age and duration of illness may also contribute.

Treating depression with physical activity in adolescents and young adults: a systematic review and meta-analysis of randomised controlled trials

2017 ◽  
Vol 48 (7) ◽  
pp. 1068-1083 ◽  
Author(s):  
A. P. Bailey ◽  
S. E. Hetrick ◽  
S. Rosenbaum ◽  
R. Purcell ◽  
A. G. Parker
Keyword(s):  
Physical Activity ◽  
Young Adults ◽  
Treatment Effect ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Adolescents And Young Adults ◽  
Controlled Trials ◽  
Randomised Controlled

AbstractWe aimed to establish the treatment effect of physical activity for depression in young people through meta-analysis. Four databases were searched to September 2016 for randomised controlled trials of physical activity interventions for adolescents and young adults, 12–25 years, experiencing a diagnosis or threshold symptoms of depression. Random-effects meta-analysis was used to estimate the standardised mean difference (SMD) between physical activity and control conditions. Subgroup analysis and meta-regression investigated potential treatment effect modifiers. Acceptability was estimated using dropout. Trials were assessed against risk of bias domains and overall quality of evidence was assessed using GRADE criteria. Seventeen trials were eligible and 16 provided data from 771 participants showing a large effect of physical activity on depression symptoms compared to controls (SMD = −0.82, 95% CI = −1.02 to −0.61, p < 0.05, I2 = 38%). The effect remained robust in trials with clinical samples (k = 5, SMD = −0.72, 95% CI = −1.15 to −0.30), and in trials using attention/activity placebo controls (k = 7, SMD = −0.82, 95% CI = −1.05 to −0.59). Dropout was 11% across physical activity arms and equivalent in controls (k = 12, RD = −0.01, 95% CI = −0.04 to 0.03, p = 0.70). However, the quality of RCT-level evidence contributing to the primary analysis was downgraded two levels to LOW (trial-level risk of bias, suspected publication bias), suggesting uncertainty in the size of effect and caution in its interpretation. While physical activity appears to be a promising and acceptable intervention for adolescents and young adults experiencing depression, robust clinical effectiveness trials that minimise risk of bias are required to increase confidence in the current finding. The specific intervention characteristics required to improve depression remain unclear, however best candidates given current evidence may include, but are not limited to, supervised, aerobic-based activity of moderate-to-vigorous intensity, engaged in multiple times per week over eight or more weeks. Further research is needed. (Registration: PROSPERO-CRD 42015024388).

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