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

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.

Intervention Mediators in a Randomized Controlled Trial to Increase Physical Activity and Fatigue Self-management Behaviors Among Adults With Multiple Sclerosis

2019 ◽  
Author(s):  
Matthew Plow ◽  
Robert W Motl ◽  
Marcia Finlayson ◽  
Francois Bethoux
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Goal Setting ◽  
Self Efficacy ◽  
Outcome Expectations ◽  
Step Count ◽  
Self Management ◽  
Post Test ◽  
The Impact

Abstract Background People with multiple sclerosis (MS) often experience fatigue, which is aggravated by inactivity. Identifying mediators of changes in physical activity (PA) and fatigue self-management (FSM) behaviors could optimize future interventions that reduce the impact of MS fatigue. Purpose To examine the effects of telephone-delivered interventions on Social Cognitive Theory constructs and test whether these constructs mediated secondary outcomes of PA and FSM behaviors. Methods Participants with MS (n = 208; Mean age = 52.1; Female = 84.6%) were randomized into contact–control intervention (CC), PA-only intervention, and PA+FSM intervention. Step count (Actigraphy) and FSM behaviors as well as self-efficacy, outcome expectations, and goal setting for PA and FSM were measured at baseline, post-test (12 weeks), and follow-up (24 weeks). Path analyses using bias-corrected bootstrapped 95% confidence intervals (CI) determined whether constructs at post-test mediated behaviors at follow-up when adjusting for baseline measures. Results Path analysis indicated that PA-only (β = 0.50, p < .001) and PA+FSM interventions (β = 0.42, p < .010) had an effect on goal setting for PA, and that PA + FSM intervention had an effect on self-efficacy for FSM (β = 0.48, p = .011) and outcome expectations for FSM (β = 0.42, p = .029). Goal setting for PA at post-test mediated the effects of PA-only (β = 159.45, CI = 5.399, 371.996) and PA + FSM interventions (β = 133.17, CI = 3.104, 355.349) on step count at follow-up. Outcome expectations for FSM at post-test mediated the effects of PA + FSM intervention on FSM behaviors at follow-up (β = 0.02, CI = 0.001, 0.058). Conclusions Goal setting for PA and outcome expectations for FSM may be important constructs to target in telephone-delivered interventions designed to reduce the impact of MS fatigue. Trial registration Clinicaltrials.gov (NCT01572714)

scholarly journals Healthy for Life Pilot Study: A Multicomponent School and Home Based Physical Activity Intervention for Disadvantaged Children

2019 ◽  
Vol 16 (16) ◽  
pp. 2935
Author(s):  
Pearce ◽  
Dollman
Keyword(s):  
Physical Activity ◽  
Social Support ◽  
Outcome Expectancy ◽  
Self Management ◽  
Control School ◽  
Data Sets ◽  
Intervention School ◽  
Disadvantaged Children ◽  
Home Based

The study aimed to develop and evaluate a multicomponent school and home based physical activity (PA) intervention in children in grades 3–7 (aged 8–13 years) and determine the psychological variables that influence PA; 10 × 1 h school-based training sessions, a home-based activity program and 4 × 1 h lifestyle workshops for parents. PA was assessed at an intervention and nearby control school using accelerometers and self-report at 3-time points: baseline, post intervention and 10-week follow-up. Self-efficacy, self-management strategies, enjoyment, perceived barriers to PA, outcome-expectancy and social support were evaluated. The study showed 73% of the children with complete data sets at the intervention school (n = 27) did not increase device measured moderate to vigorous PA (MVPA) in the after-school period (3 p.m. to 6 p.m.) or over the whole day or during school break time immediately following the intervention or at follow-up, as compared to 70% of children with complete data sets at the control school (n = 35; p > 0.05 for all). Overall, 59% of boys attained more than double the recommended 120 min of MVPA each day compared to 42% of girls (p = 0.013). At the baseline, children’s self-reported PA in the intervention school positively correlated with: outcome expectancy (R = 0.240, p = 0.015), enjoyment (R = 0.339, p < 0.001), self-efficacy (R = 0.399, p < 0.001), self-management (R = 0.617, p < 0.001), social support at home (R = 0.406, p < 0.001), and social support at school (R = 0.407, p < 0.001). Similar relationships were observed after the intervention and at follow-up. Focus groups with the children, parents and interviews with teachers identified areas for improvement of the intervention. In conclusion, while the multifaceted approach to improve PA was ineffective over the time span of the study, important predictors of PA in this sample of disadvantaged children were identified.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

Repurposing Domperidone in Secondary Progressive MS

Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000011863
Author(s):  
Marcus W. Koch ◽  
Kayla Sage ◽  
Sharanjit Kaur ◽  
Janet Kim ◽  
Graziela Cerchiaro ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Progressive Multiple Sclerosis ◽  
Secondary Progressive Multiple Sclerosis ◽  
Phase 2 ◽  
Disability Progression ◽  
Two Stage ◽  
Serious Adverse Events ◽  
Secondary Progressive ◽  
Link Type

ObjectiveTo assess whether treatment with the generic drug domperidone can reduce the progression of disability in secondary progressive multiple sclerosis (SPMS), we conducted a phase 2 futility trial following the Simon two-stage design.MethodsWe enrolled patients in an open-label, Simon two-stage, single-center, phase 2, single-arm futility trial at the Calgary MS Clinic if they met the following criteria: age 18–60 years, SPMS, screening EDSS score of 4.0–6.5 and screening T25FW of 9 seconds or more. Patients received domperidone 10 mg QID for one year. The primary outcome was worsening of disability, defined as worsening of the T25FW performance by 20% or more at 12 months compared to at baseline. This trial is registered with ClinicalTrials.gov, number NCT02308137.ResultsBetween February 13, 2015 and January 3, 2020, 110 patients were screened, 81 received treatment, 64 completed follow-up, of whom 62 were analysed. The study did not meet its primary endpoint: 22 of 62 (35%) patients experienced significant worsening of disability, which is close to the expected proportion of 40%, and above the pre-defined futility threshold. Patients with higher prolactin levels during the study had a significantly lower risk of disability progression, which may warrant further investigation. Domperidone treatment was reasonably well tolerated, but adverse events occurred in 84% and serious adverse events in 15% of patients.ConclusionsDomperidone treatment could not reject futility in reducing disability progression in SPMS. The Simon two-stage trial model may be a useful model for phase 2 studies in progressive MS.Classification of evidenceThis study provides Class III evidence that in individuals with secondary progressive multiple sclerosis participating in a futility trial, domperidone treatment could not reject futility in reducing disability progression at 12 months.

scholarly journals Cyclophosphamide Versus Rituximab in Progressive Forms of Multiple Sclerosis

2020 ◽  
Author(s):  
Masoud Etemadifar ◽  
Shadi Ghourchian ◽  
Nazanin Mahinparvar ◽  
Mehri Salari ◽  
Fatemeh Etemadifar ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Progressive Multiple Sclerosis ◽  
The Other ◽  
Medical Sciences ◽  
Mri Findings ◽  
Disability Score ◽  
Radiologic Findings ◽  
Spss Software ◽  
And Gender

This study aimed to compare the efficacy of rituximab versus Cyclophosphamide on active secondary progressive multiple sclerosis (SPMS). The randomized clinical trial was performed from 2015 to 2017 in multiple sclerosis (MS) clinics affiliated to Isfahan MS society (IMSS). Patients were randomized to two groups, and one of them received Rituximab that was repeated every six months in case of medical indication. The other one received a monthly pulse of methylprednisolone plus cyclophosphamide (Endoxan, Baxter, UK) until two years. Expanded disabilities status scale (EDSS), clinical, and MRI findings were assessed every six months. Statistical analysis was performed using SPSS software. 39 patients in the Rituximab group and 30 in the Cyclophosphamide group with similar age and gender distribution were entered for analysis. At baseline, the mean number of attacks in the Rituximab group was significantly more than the Cyclophosphamide group (P=0.0001). After 6, 12, and 18 months of treatment, the rate of attacks was similar between groups although it increased significantly in the Rituximab group (P=0.030) after 24 months of treatment. EDSS was increased in the Rituximab group more than the other group at the end of the study. Both drugs were well-tolerated by patients. The EDSS was increased in the Rituximab group but the disability score did not worsen in the Cyclophosphamide group. Both therapies were associated with a reduction in disease attacks and improvement in radiologic findings in a two-year period of follow-up. © 2019 Tehran University of Medical Sciences. All rights reserved. Acta Med Iran 2019;57(8):484-491.

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