scholarly journals Physical Activity Together for People With Multiple Sclerosis and Their Care Partners: Protocol for a Feasibility Randomized Controlled Trial of a Dyadic Intervention

10.2196/18410 ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. e18410
Author(s):  
Afolasade Fakolade ◽  
Julie Cameron ◽  
Odessa McKenna ◽  
Marcia L Finlayson ◽  
Mark S Freedman ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Research Ethics ◽  
Subjective Experience ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Randomized Controlled ◽  
Care Partners ◽  
Research Ethics Board

Background Physical activity (PA) is beneficial for all people; however, people affected by multiple sclerosis (MS) find regular PA challenging. These people may include individuals with advanced disabilities and their care partners. Objective The objective of this study is to determine the feasibility of a dyadic PA intervention for people with advanced MS and their care partners. Methods This study is a randomized controlled feasibility trial of a 12-week intervention, with 1:1 allocation into an immediate intervention condition or delayed control condition. A target of 20 people with MS–care partner dyads will be included. The outcomes will be indicators of process, resources, management, and scientific feasibility. Participant satisfaction with the intervention components will be evaluated using a satisfaction survey. The subjective experience of participation in the study will be explored using semistructured interviews. Results The project is funded by the Consortium of Multiple Sclerosis Centers. This protocol was approved by the Ottawa Hospital Research Ethics Board (20190329-01H) and the University of Ottawa Research Ethics Board (H-09-19-4886). The study protocol was registered with ClinicalTrials.gov in February 2020. The findings of this feasibility trial will be disseminated through presentations at community events to engage the MS population in the interpretation of our results and in the next steps. The results will also be published in peer-reviewed journals and presented to the scientific community at national and international MS conferences. Conclusions The data collected from this feasibility trial will be used to refine the intervention and materials in preparation for a pilot randomized controlled trial. Trial Registration ClinicalTrials.gov NCT04267185; https://clinicaltrials.gov/ct2/show/NCT04267185. International Registered Report Identifier (IRRID) PRR1-10.2196/18410

scholarly journals Physical Activity Together for People With Multiple Sclerosis and Their Care Partners: Protocol for a Feasibility Randomized Controlled Trial of a Dyadic Intervention (Preprint)

2020 ◽  
Author(s):  
Afolasade Fakolade ◽  
Julie Cameron ◽  
Odessa McKenna ◽  
Marcia L Finlayson ◽  
Mark S Freedman ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Research Ethics ◽  
Subjective Experience ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Randomized Controlled ◽  
Care Partners ◽  
Research Ethics Board

BACKGROUND Physical activity (PA) is beneficial for all people; however, people affected by multiple sclerosis (MS) find regular PA challenging. These people may include individuals with advanced disabilities and their care partners. OBJECTIVE The objective of this study is to determine the feasibility of a dyadic PA intervention for people with advanced MS and their care partners. METHODS This study is a randomized controlled feasibility trial of a 12-week intervention, with 1:1 allocation into an immediate intervention condition or delayed control condition. A target of 20 people with MS–care partner dyads will be included. The outcomes will be indicators of process, resources, management, and scientific feasibility. Participant satisfaction with the intervention components will be evaluated using a satisfaction survey. The subjective experience of participation in the study will be explored using semistructured interviews. RESULTS The project is funded by the Consortium of Multiple Sclerosis Centers. This protocol was approved by the Ottawa Hospital Research Ethics Board (20190329-01H) and the University of Ottawa Research Ethics Board (H-09-19-4886). The study protocol was registered with ClinicalTrials.gov in February 2020. The findings of this feasibility trial will be disseminated through presentations at community events to engage the MS population in the interpretation of our results and in the next steps. The results will also be published in peer-reviewed journals and presented to the scientific community at national and international MS conferences. CONCLUSIONS The data collected from this feasibility trial will be used to refine the intervention and materials in preparation for a pilot randomized controlled trial. CLINICALTRIAL ClinicalTrials.gov NCT04267185; https://clinicaltrials.gov/ct2/show/NCT04267185. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/18410

scholarly journals Randomized controlled trial of an e-learning designed behavioral intervention for increasing physical activity behavior in multiple sclerosis

2017 ◽  
Vol 3 (4) ◽  
pp. 205521731773488 ◽  
Author(s):  
Robert W Motl ◽  
Elizabeth A Hubbard ◽  
Rachel E Bollaert ◽  
Brynn C Adamson ◽  
Dominique Kinnett-Hopkins ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Behavioral Intervention ◽  
Controlled Trial ◽  
Analysis Of Covariance ◽  
Learning Approaches ◽  
Positive Effects ◽  
Randomized Controlled ◽  
E Learning

Background Internet-delivered, behavioral interventions represent a cost-effective, broadly disseminable approach for teaching persons with multiple sclerosis (MS) the theory-based skills, techniques, and strategies for changing physical activity. Objectives This pilot, randomized controlled trial examined the efficacy of a newly developed Internet website based on e-learning approaches that delivered a theory-based behavior intervention for increasing physical activity and improving symptoms, walking impairment, and neurological disability. Methods Participants with MS ( N = 47) were randomly assigned into behavioral intervention ( n = 23) or waitlist control ( n = 24) conditions delivered over a six-month period. Outcomes were administered before and after the six-month period using blinded assessors, and data were analyzed using analysis of covariance in SPSS. Results There was a significant, positive intervention effect on self-reported physical activity ( P = 0.05, [Formula: see text] = 0.10), and non-significant improvement in objectively measured physical activity ( P = 0.24, [Formula: see text] = 0.04). There were significant, positive effects of the intervention on overall ( P = 0.018, [Formula: see text] = 0.13) and physical impact of fatigue ( P = 0.003, [Formula: see text] = 0.20), self-reported walking impairment ( P = 0.047, [Formula: see text] = 0.10), and disability status ( P = 0.033, [Formula: see text] = 0.11). There were non-significant improvements in fatigue severity ( P = 0.10, [Formula: see text] = 0.06), depression ( P = 0.10, [Formula: see text] = 0.07) and anxiety ( P = 0.06, [Formula: see text] = 0.09) symptoms, and self-reported disability ( P = 0.10, [Formula: see text] = 0.07). Conclusions We provide evidence for the efficacy of an Internet-based behavioral intervention with content delivered through interactive video courses grounded in e-learning principles for increasing physical activity and possibly improving secondary outcomes of fatigue, depression, anxiety, and walking impairment/disability in persons with MS.

scholarly journals Physical Activity and Fatigue in Multiple Sclerosis: Secondary Outcomes from a Double-blinded Randomized Controlled Trial of Cocoa Flavonoid Drinks

2021 ◽  
pp. 53-61
Author(s):  
Maedeh Mansoubi ◽  
Shelly Coe ◽  
Jo Cossington ◽  
Johnny Collet ◽  
Miriam Clegg ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
United Kingdom ◽  
Controlled Trial ◽  
Activity Levels ◽  
Randomized Controlled ◽  
Physical Activity Levels ◽  
Relationship Of ◽  
The Relationship

Physical Activity and Fatigue in Multiple Sclerosis: Secondary Outcomes from a Double-blinded Randomized Controlled Trial of Cocoa Flavonoid Drinks Maedeh Mansoubi()1,2, Shelly Coe1,2,3, Jo Cossington1, Johnny Collet1,2, Miriam Clegg4, Jacqueline Palace5, Ana Cavey5, Gabriele C DeLuca5, Martin Ovington1 and Helen Dawes1,2,6  1Center for Movement, Occupational and Rehabilitation Sciences, Oxford Institute of Nursing, Midwifery and Allied Health Research, Oxford Brookes University, Oxford, United Kingdom 2Oxford Clinical Allied Technology and Trial Services Unit (OxCATTS), Oxford, United Kingdom 3Oxford Brookes Center for Nutrition and Health, Oxford Brookes University, Oxford, United Kingdom 4Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading, Reading, United Kingdom 5Department of Neurology, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom 6Oxford Health NHS Foundation Trust, United Kingdom © The Authors   Abstract Fatigue is a common and pervasive symptom reducing physical activity in people with multiple sclerosis (pwMS). Exercise may reduce fatigue, although evidence to guide optimal prescription is limited. Specifically, supportive evidence for the timing of exercise for fatigue management or the impact of dietary supplements is unavailable. We performed intensive phenotyping of the interrelation of time of day, physical activity levels, and fatigue to evidence exercise prescription in 40 pwMS participating in a six week randomized controlled trial of morning flavonoid intake (n=19) or a control (n=21). Physical activity was measured over seven days by using an accelerometer at baseline, week three and week six. Participants self-reported their fatigue on a 1–10 rating scale at 10 am, 3 pm, and 8 pm daily. Physical activity levels were calculated for 2.5 h before and after fatigue was reported. Generalized estimating equations were used to explore the time of day fatigue profiles, the relationship of physical activity to fatigue, and the effect of morning flavonoids on this relationship. Participants experienced higher fatigue at 8 pm (4.64±2.29) than at 3 pm (4.39±2.28) and 10 am (3.90±2.10) (P<0.001). Higher fatigue was shown to predict subsequent lower physical activity behavior (P=0.015), but physical activity did not predict higher subsequent fatigue (P>0.05). Morning flavonoid cocoa consumption reduced the relationship of fatigue to physical activity (P=0.049) and fatigue to time of the day (P<0.001). Fatigue levels increased during the day and higher fatigue reduced physical activity in pwMS, but physical activity did not increase fatigue. In addition, morning cocoa reduced daytime fatigue and the relationship of fatigue to subsequent physical activity levels. Therefore morning exercise prescription is indicated; in combination with dietary flavonoids, it may optimize exercise and physical activity potential in pwMS. Trial registration: ISRCTN69897291, https://doi.org/10.1186/ISRCTN69897291 Registration name: A study to determine whether the daily consumption of flavonoid-rich pure cocoa has the potential to reduce fatigue in people with relapsing-remitting multiple sclerosis (RRMS). Consort Statement: In this study, we adhered to CONSORT guidelines. As this paper is a secondary analysis, we therefore did not repeat some parts in the methods, results, diagrams, or tables that have been published in the first paper authored by Coe et al. 2019.

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