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Study protocol: improving cognition in people with progressive multiple sclerosis: a multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx).

ABSTRACT: BACKGROUND:Cognitive dysfunction affects up to 70% of people with progressive MS (PMS). It can exert a deleterious effect on activities of daily living, employment and relationships. Preliminary evidence suggests that performance can improve with cognitive rehabilitation (CR) and aerobic exercise (EX), but existing data are predominantly from people with relapsing-remitting MS without cognitive impairment. There is therefore a need to investigate whether this is also the case in people with progressive forms of the disease who have objectively identified cognitive impairment. It is hypothesized that CR and EX are effective treatments for people with PMS who have cognitive impairment, in particular processing speed (PS) deficits, and that a combination of these two treatments is more effective than each individual treatment given alone. We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques. METHODS:This study is a multisite, randomized, double-blinded, sham controlled clinical trial of CR and aerobic exercise. Three hundred and sixty subjects from 11 sites will be randomly assigned into one of four groups: CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise. Subjects will participate in the assigned treatments for 12?weeks, twice a week. All subjects will have a cognitive and physical assessment at baseline, 12?weeks and 24?weeks. In an embedded sub-study, approximately 30% of subjects will undergo structural and functional MRI to investigate the neural mechanisms underlying the behavioral response. The primary outcome is the Symbol Digit Modalities Test (SDMT) measuring PS. Secondary outcome measures include: indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI. DISCUSSION:The study is being undertaken in 6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages. The rationale for this approach is to obtain a robustly powered sample size and to demonstrate that these two interventions can be given effectively in multiple countries and in different languages. TRIAL REGISTRATION:The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated.

SUBMITTER: Feinstein A

PROVIDER: S-EPMC7245035 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Study protocol: improving cognition in people with progressive multiple sclerosis: a multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx).

Feinstein Anthony A Amato Maria Pia MP Brichetto Giampaolo G Chataway Jeremy J Chiaravalloti Nancy N Dalgas Ulrik U DeLuca John J Feys Peter P Filippi Massimo M Freeman Jennifer J Meza Cecilia C Inglese Matilde M Motl Robert W RW Rocca Maria Assunta MA Sandroff Brian M BM Salter Amber A Cutter Gary G

BMC neurology 20200522 1

<h4>Background</h4>Cognitive dysfunction affects up to 70% of people with progressive MS (PMS). It can exert a deleterious effect on activities of daily living, employment and relationships. Preliminary evidence suggests that performance can improve with cognitive rehabilitation (CR) and aerobic exercise (EX), but existing data are predominantly from people with relapsing-remitting MS without cognitive impairment. There is therefore a need to investigate whether this is also the case in people w ...[more]

PMID: 32443981

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Project description:Purpose: Exercise training reveals high potential to beneficially impact cognitive performance in persons with multiple sclerosis (pwMS). Research indicates that high-intensity interval training (HIIT) has potentially higher effects on physical fitness and cognition compared to moderate continuous exercise. This study (i) compares the effects of a 3-week HIIT and moderate continuous exercise training on cognitive performance and cardiorespiratory fitness of pwMS in an overall analysis and (ii) investigates potential effects based on baseline cognitive status in a subgroup analysis. Methods: Seventy-five pwMS were randomly assigned to an intervention (HIIT: 5 × 1.5-min intervals at 95-100% HRmax, 3 ×/week) or active control group (CG: 24 min continuous exercise at 65% HRmax, 3 ×/week). Cognitive performance was assessed pre- and post-intervention with the Brief International Cognitive Assessment for MS (BICAMS). (I) To examine potential within (time) and interaction (time × group) effects in the overall analysis, separate analyses of covariance (ANCOVA) were conducted. (II) For the subgroup analysis, participants were divided into two groups [intact cognition or impaired cognition (>1.5 standard deviation (SD) compared to healthy, age-matched norm data in at least one of the three tests of the BICAMS]. Potential impacts of cognitive status and intervention were investigated with multivariate analyses of variance (MANOVA). Results: Overall analysis revealed significant time effects for processing speed, verbal learning, rel. VO2peak, and rel. power output. A time*group interaction effect was observed for rel. power output. Subgroup analysis indicated a significant main effect for cognition (impaired cognition vs. intact cognition). Subsequent post-hoc analysis showed significant larger effects on verbal learning in pwMS with impaired cognition. Conclusion: Current results need to be confirmed in a powered randomized controlled trial with cognitive performance as primary endpoint and eligibility based on cognitive performance that is assessed prior to study inclusion.

Project description:ObjectiveTo determine efficacy of aerobic exercise for cognitive function in younger healthy adults.MethodsIn a randomized, parallel-group, observer-masked, community-based clinical trial, 132 cognitively normal individuals aged 20-67 with below median aerobic capacity were randomly assigned to one of two 6-month, 4-times-weekly conditions: aerobic exercise and stretching/toning. Efficacy measures included aerobic capacity; cognitive function in several domains (executive function, episodic memory, processing speed, language, and attention), everyday function, body mass index (BMI), and cortical thickness.ResultsAerobic capacity increased significantly (β = 2.718; p = 0.003), and BMI decreased significantly (β = -0.596; p = 0.013) in the aerobic exercise but not in the stretching/toning condition. Executive function improved significantly in the aerobic exercise condition; this effect was moderated by age (β = 0.018 SD/y; p = 0.028). At age 40, the executive function measure increased by 0.228 SD (95% confidence interval [CI] 0.007-0.448), and by 0.596 SD (95% CI 0.219-0.973) at age 60. Cortical thickness increased significantly in the aerobic exercise group in a left frontal region and did not interact with age. Controlling for age and baseline performance, individuals with at least one APOE ε4 allele showed less improvement in executive function with aerobic exercise (β = 0.5129, 95% CI 0.0381-0.988; p = 0.0346).ConclusionsThis randomized clinical trial demonstrates the efficacy of aerobic exercise for cognition in adults age 20-67. The effect of aerobic exercise on executive function was more pronounced as age increased, suggesting that it may mitigate age-related declines. Increased cortical thickness suggests that aerobic exercise contributes to brain health in individuals as young as age 20.Clinicaltrialsgov identifierNCT01179958.Classification of evidenceThis study provides Class II evidence that for adults age 20-67 with below median aerobic capacity, aerobic exercise significantly improves executive function but not other measures of cognitive function.

Dataset Information

Study protocol: improving cognition in people with progressive multiple sclerosis: a multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx).

Publications

Study protocol: improving cognition in people with progressive multiple sclerosis: a multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx).

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