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): 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): 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 An online family-based self-monitoring and goal-setting intervention to improve children’s physical activity: the FRESH feasibility trial and three-arm pilot RCT

2021 ◽  
Vol 9 (9) ◽  
pp. 1-116
Author(s):  
Esther MF van Sluijs ◽  
Helen E Brown ◽  
Emma Coombes ◽  
Claire Hughes ◽  
Andrew P Jones ◽  
...  
Keyword(s):  
Public Health ◽  
Physical Activity ◽  
Health Research ◽  
Delphi Study ◽  
Family Members ◽  
Public Health Research ◽  
Feasibility Trial ◽  
Recruitment Strategies ◽  
Family Based

Background Family-based physical activity promotion presents a promising avenue for promoting whole-family physical activity, but high-quality research is lacking. Objectives To assess the feasibility, acceptability and preliminary effectiveness of FRESH (Families Reporting Every Step to Health), a child-led online family-based physical activity intervention; and to identify effective and resource-efficient family recruitment strategies. Design The project consisted of (1) a randomised feasibility trial, (2) a randomised controlled pilot trial and (3) a systematic review and Delphi study. Setting Norfolk/Suffolk counties, UK. Participants Families, recruited from schools, workplaces and community settings, were eligible to participate if one child aged 7–11 years and one adult responsible for their care provided written consent; all family members could participate. Interventions The FRESH intervention, guided by self-determination theory, targeted whole families and was delivered via an online platform. All family members received pedometers and were given website access to select family step challenges to ‘travel’ to target cities around the world, log steps, and track progress as they virtually globetrotted. Families were randomised to FRESH intervention, pedometer-only or control arm. Main outcome measures Physical (e.g. blood pressure), psychosocial (e.g. family functioning) and behavioural (e.g. device-measured family physical activity) measures were collected at baseline and at 8- and 52-week follow-up. A mixed-methods process evaluation assessed the acceptability of the intervention and evaluation. Data sources review Systematic search of four databases (Cochrane Library, PubMed, PsycINFO and SCOPUS). Review methods Articles were screened in duplicate, and data extraction was fully checked. Academic experts participated in the three-round Delphi study. Data were combined to identify effective and resource-efficient family recruitment strategies. Inclusion criteria Included generally healthy school-aged children and at least one adult; intervention attempted to change physical activity, sedentary behaviour, screen use, diet, or prevent overweight/obesity in multiple family members; presented relevant measure of effect in children and adults. Results The feasibility study (12 families, 32 participants; 100% retention at 8 weeks) demonstrated the feasibility and acceptability of FRESH, but highlighted that adaptations were required. Of 41 families recruited in the pilot study (149 participants), 98% and 88% were retained at the 8-week and 52-week follow-up, respectively. More children in the FRESH arm self-reported doing more family physical activity, and they thought that FRESH was fun. There were no notable between-group differences in children’s outcomes. Change in moderate to vigorous physical activity at 8 weeks favoured FRESH intervention adults [vs. control: 9.4 minutes/week (95% confidence interval 0.4 to 18.4) vs. pedometer only: 15.3 (95% confidence interval 6.0 to 24.5)], and was stronger in fathers, but this was not maintained. In 49 included studies, apart from recruitment settings and strategies used (reported in 84% and 73% of the studies, respectively), recruitment details were scarce. School-based recruitment was predominant. The Delphi study identified a wide range of recruitment settings and strategies. Limitations Recruitment was the main limitation of the FRESH studies; generalisability of the proposed recruitment strategies may be limited. Conclusions This study has demonstrated the feasibility and acceptability of the FRESH intervention. However, we failed to recruit the target sample size and were unable to demonstrate a signal of effectiveness. Future research should employ a multifaceted recruitment approach. Future work Further refinements to intervention delivery and recruitment methods should be investigated. Study registration Current Controlled Trials ISRCTN12789422 and PROSPERO CRD42019140042. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 9. See the NIHR Journals Library website for further project information.

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.

scholarly journals Ocrelizumab in Multiple Sclerosis: A Real-World Study From Spain

2021 ◽  
Vol 11 ◽  
Author(s):  
Angel P. Sempere ◽  
Leticia Berenguer-Ruiz ◽  
Ines Borrego-Soriano ◽  
Amparo Burgos-San Jose ◽  
Luis Concepcion-Aramendia ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Practice ◽  
Real World ◽  
Median Number ◽  
Progressive Multiple Sclerosis ◽  
Primary Progressive Multiple Sclerosis ◽  
Clinical Practice Setting ◽  
Number Of Treatment ◽  
Relapsing Multiple Sclerosis

Objectives: The aim of this study was to describe the tolerability, safety, and effectiveness of ocrelizumab for primary progressive multiple sclerosis (PPMS) and relapsing multiple sclerosis (RMS) in a clinical practice setting.Methods: In this retrospective observational study, we analyzed clinical and MRI data in all patients with PPMS and RMS who had received at least one infusion of ocrelizumab in two health areas in south-eastern Spain. Patients involved in any ocrelizumab trial and those patients with a follow-up shorter than 6 months were excluded.Results: The cohort included 70 patients (42 women) who had received ocrelizumab; 30% had PPMS and 70%, RMS. At baseline, patients' mean age was 47.1 years in the PPMS group and 39.2 years in the RMS group, while the median EDSS was 3.0 and 2.5, respectively. Median follow-up was 13.6 months. The median number of treatment cycles was three. Most patients remained free from clinical and MRI activity after ocrelizumab initiation. Baseline MRI showed T1 Gd-enhancing lesions in 57% of the patients; by the first MRI control at 4–6 months, all patients except one were free of T1 Gd-enhancing lesions (69/70, 98.6% P &lt; 0.001). The proportion of patients with NEDA was 94% in the group of RMS patients who were followed for at least 1 year. Ocrelizumab was generally well-tolerated; the most common adverse events were infusion-related reactions and infections, none of which were serious.Conclusions: Our real-world study supports the tolerability, safety, and effectiveness of ocrelizumab in clinical practice.

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