Face-to-Face or Telematic Cognitive Stimulation in Patients with Multiple Sclerosis and Cognitive Impairment: Why Not Both?

Introduction. Cognitive impairment (CI) affects 40–65% of patients with multiple sclerosis (MS). Few studies address telematic cognitive stimulation (TCS) in MS. The objective of this study is to evaluate the efficacy and impact of telestimulation or distance cognitive stimulation (TCS), with and without the support of face-to-face cognitive stimulation (FCS) in cognitive impairment in MS. Methods. Multicentre, prospective, randomised, controlled study. We will include 98 MS patients with EDSS ≤ 6, symbol digit modality test (SDMT) ≤ Pc 25, and Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ) > 26 points. Patients will be randomised into 3 groups, a TCS group, a mixed TCS/FCS group, and a control group. CS is performed 3 days a week for 3 months. Processing speed, memory, attention, and executive functions will be rehabilitated. FCS will include ecological exercises and strategies. EDSS and a cognitive evaluation (SDMT, CTMT, PASAT, and TAVEC), MSNQ, psychological impact scales (MSIS), and depression (BDI) will be carried out, baseline, postrehabilitation, and also 6 and 12 months later, to evaluate the effect of CS in the longer term. Conclusion. This study could help to establish the usefulness of TCS or, in its absence, TCS with face-to-face help for CI in MS. The interest lies in the clear benefits of remote rehabilitation in the daily life of patients.

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The Efficacy of Mindfulness-Based Alzheimer’s Stimulation (Mbas) in the Progression of Cognitive Impairment: A Double-Blind, Randomized Clinical Trial

European Journal of Investigation in Health, Psychology and Education ◽

10.3390/ejihpe4020009 ◽

2014 ◽

Vol 4 (2) ◽

pp. 101-112

Author(s):

Domingo Jesús Quintana Hernández ◽

María del Pino Quintana Montesdeoca

Keyword(s):

Clinical Trial ◽

Cognitive Impairment ◽

Randomized Clinical Trial ◽

Repeated Measures ◽

Cognitive Stimulation ◽

Mindfulness Practice ◽

Controlled Study ◽

Control Group ◽

Double Blind ◽

And Control

We conducted a randomized, controlled study in order to investigate the feasibility, security as well as the effects of the practice of mindfulness upon the evolution of AD. The efficacy of a Mindfulness-based Cognitive Stimulation program for Alzheimer’s patients was tested in this double-blind, randomized clinical trial, using repeated measures of CAMDEX (CAMCOG y MMSE) every six months during two years. A total of 168 patients, presenting a Probable Alzheimer Disease according to NINCDS-ADRDA criteria and treated with donepezil, were randomly assigned to the four following non-pharmacological treatments: standard cognitive stimulation, progressive muscular relaxation, mindfulness-based Alzheimer stimulation and control group, which received no intervention. Each experimental group worked in 90-minute sessions, three times per week during two years (a total of 96 weeks). Results indicated that the Mindfulness-based Alzheimer Stimulation group did not show as much a significant decline of cognitive function as the other groups did. Therefore, it seems that mindfulness practice, as implemented in this program, can have a preventive role against the progression of cognitive impairment in AD. These results support the use of mindfulness as a non-pharmacological treatment.

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The Effects of Two Intervention Strategies to Reduce the Intake of Salt and the Sodium-To-Potassium Ratio on Cardiovascular Risk Factors. A 4-Month Randomised Controlled Study among Healthy Families

Nutrients ◽

10.3390/nu12051467 ◽

2020 ◽

Vol 12 (5) ◽

pp. 1467

Author(s):

Ulla Toft ◽

Nanna Louise Riis ◽

Anne Dahl Lassen ◽

Ellen Trolle ◽

Anne Helms Andreasen ◽

...

Keyword(s):

Risk Factors ◽

Cardiovascular Risk ◽

Cardiovascular Risk Factors ◽

Plasma Cholesterol ◽

Plasma Renin ◽

Controlled Study ◽

Control Group ◽

Randomised Controlled Study ◽

Group A ◽

Randomised Controlled

The aim was to examine the effects of two different salt reduction strategies on selected cardiovascular risk factors. The study was a four-month cluster randomised controlled study. Eighty-nine healthy Danish families (309 individuals) were randomly assigned to either (A) gradually salt-reduced bread, (B) gradually salt-reduced bread and dietary counselling to further reduce salt intake and increase potassium intake or (C) standard bread (control). The effect was assessed using linear mixed models. Intention to treat analyses comparing changes in the three groups showed a significant reduction in body fat percent (−1.31% (−2.40; −0.23)) and a borderline significant reduction in total plasma cholesterol (−0.25 mmol/L (−0.51; 0.01) and plasma renin (−0.19 pmol/L (−0.39; 0.00) in group A compared to the control group. Adjusted complete case analyses showed a significant reduction in total plasma cholesterol (−0.29 mmol/L (−0.50; −0.08), plasma LDL cholesterol (−0.08 mmol/L (−0.15; −0.00)), plasma renin (−0.23 pmol/L (−0.41; −0.05)), plasma adrenaline (−0.03 nmol/L (−0.06; −0.01)) and body fat percent (−1.53% (−2.51; −0.54)) in group A compared to the control group. No significant changes were found in group B compared to the control group. In conclusion, receiving sodium reduce bread was associated with beneficial changes in cardiovascular risk factors. No adverse effects were observed.

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Surgical prevention of femoral neck fractures in elderly osteoporotic patients: a randomised controlled study on the prevention nail system device

Hip International ◽

10.1177/1120700018813207 ◽

2018 ◽

Vol 28 (2_suppl) ◽

pp. 78-83

Author(s):

Sandro Giannini ◽

Eugenio Chiarello ◽

Antonio Mazzotti ◽

Guiseppe Tedesco ◽

Cesare Faldini

Keyword(s):

Femoral Neck ◽

Hip Fractures ◽

Controlled Trial ◽

Surgical Techniques ◽

Secondary Outcome ◽

Controlled Study ◽

Control Group ◽

Group A ◽

Randomised Controlled ◽

Surgical Prevention

Introduction: Hip fractures represent an enormous challenge for our health care system. The aim of this randomised controlled trial was to assess both efficacy and safety of a novel device called Prevention Nail System (PNS) and developed for the surgical prevention of a contralateral femoral neck fracture (FNF) in elderly osteoporotic patients. Methods: Primary outcome was to evaluate, in patients suffering from osteoporotic FNF, the effectiveness of PNS in reducing the incidence of a contralateral hip fracture. Secondary outcome was to evaluate the safety of this device therefore intra- and postoperative complications were recorded. Results: 72 patients, with an age ⩾65 years old, were enrolled (38 study group (group A) and 34 control group (group B). 3 and 5 contralateral FNF were recorded respectively in group A and B. An interim analysis showed a non-effectiveness of the device therefore enrollment was suspended. Discussion: In all group A failures a difficult positioning of the PNS was recorded: surgical techniques errors may have affected the result. Nevertheless, it is improbable to hypothesise that, without substantial modifications to the PNS design, this could significantly reduce the incidence of FNF. Considering that current pharmacological approach can achieve, at best, a marginal reduction in FNF especially in patients at high risk, complementary approaches to provide immediate prevention of hip fractures may need to be developed. Clinical Trial Protocol: N° 263. 03 June 2008.

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The Efficacy of Mindfulness-Based Alzheimer’s Stimulation (Mbas) in the Progression of Cognitive Impairment: A Double-Blind, Randomized Clinical Trial

European Journal of Investigation in Health, Psychology and Education ◽

10.1989/ejihpe.v4i2.57 ◽

2014 ◽

Vol 4 (2) ◽

pp. 101-112

Author(s):

Domingo Jesús Quintana Hernández ◽

María del Pino Quintana Montesdeoca

Keyword(s):

Clinical Trial ◽

Cognitive Impairment ◽

Randomized Clinical Trial ◽

Repeated Measures ◽

Cognitive Stimulation ◽

Mindfulness Practice ◽

Controlled Study ◽

Control Group ◽

Double Blind ◽

And Control

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Investigation of the effects of computer assisted cognitive rehabilitation in multiple sclerosis patients: A randomised-controlled study

10.26226/morressier.59a3e8b7d462b8028d895954 ◽

2017 ◽

Author(s):

Aysun Soysal

Keyword(s):

Multiple Sclerosis ◽

Cognitive Rehabilitation ◽

Controlled Study ◽

Computer Assisted ◽

Randomised Controlled Study ◽

Randomised Controlled ◽

Multiple Sclerosis Patients

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Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

BMJ Open ◽

10.1136/bmjopen-2020-041500 ◽

2021 ◽

Vol 11 (2) ◽

pp. e041500

Author(s):

Zoe Menczel Schrire ◽

Craig L Phillips ◽

Shantel L Duffy ◽

Nathaniel S Marshall ◽

Loren Mowszowski ◽

...

Keyword(s):

Oxidative Stress ◽

Blood Pressure ◽

Cognitive Impairment ◽

Mild Cognitive Impairment ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Feasibility Trial ◽

Controlled Study ◽

Brain Oxidative Stress ◽

Randomised Controlled

IntroductionMelatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).Methods and analysisThe study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.Ethics and disseminationThis protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).Protocol versionV.8 15 October 2020.

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Effect of Whole-Body Cryotherapy on Morphological, Rheological and Biochemical Indices of Blood in People with Multiple Sclerosis

Journal of Clinical Medicine ◽

10.3390/jcm10132833 ◽

2021 ◽

Vol 10 (13) ◽

pp. 2833

Author(s):

Bartłomiej Ptaszek ◽

Aneta Teległów ◽

Justyna Adamiak ◽

Jacek Głodzik ◽

Szymon Podsiadło ◽

...

Keyword(s):

Multiple Sclerosis ◽

Neurological Diseases ◽

Venous Blood ◽

Whole Body ◽

Controlled Study ◽

Control Group ◽

Blood Indices ◽

Rheological Indices ◽

Whole Body Cryotherapy ◽

The Impact

The aim of this study was to examine and assess the impact of a series of 20 whole-body cryotherapy (WBC) treatments on the biochemical and rheological indices of blood in people with multiple sclerosis. In this prospective controlled study, the experimental group consisted of 15 women aged 34–55 (mean age, 41.53 ± 6.98 years) with diagnosed multiple sclerosis who underwent a series of whole-body cryotherapy treatments. The first control group consisted of 20 women with diagnosed multiple sclerosis. This group had no intervention in the form of whole-body cryotherapy. The second control group consisted of 15 women aged 30–49 years (mean age, 38.47 ± 6.0 years) without neurological diseases and other chronic diseases who also underwent the whole-body cryotherapy treatment. For the analysis of the blood indices, venous blood was taken twice (first, on the day of initiation of whole-body cryotherapy treatments and, second, after a series of 20 cryotherapy treatments). The blood counts were determined using an ABX MICROS 60 hematological analyzer (USA). The LORCA analyzer (Laser–Optical Rotational Cell Analyzer, RR Mechatronics, the Netherlands) was used to study the aggregation and deformability of erythrocytes. The total protein serum measurement was performed using a Cobas 6000 analyzer, Roche and a Proteinogram-Minicap Sebia analyzer. Fibrinogen determinations were made using a Bio-Ksel, Chrom-7 camera. Statistically significant differences and changes after WBC in the levels of red blood cells (RBC), hemoglobin (HGB), hematocrit (HCT), elongation index, total extend of aggregation (AMP), and proteins (including fibrinogen) were observed. However, there was no significant effect of a series of 20 WBC treatments on changes in blood counts, rheology, and biochemistry in women with multiple sclerosis. Our results show that the use of WBC has a positive effect on the rheological properties of the blood of healthy women.

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Effect of adjunctive sodium hyaluronate versus surfactant nasal irrigation on mucociliary clearance in allergic rhinitis: a single-blind, randomised, controlled study

The Journal of Laryngology & Otology ◽

10.1017/s0022215121000967 ◽

2021 ◽

pp. 1-4

Author(s):

E Ocak ◽

S Mulazimoglu ◽

D Kocaoz ◽

E Mirici ◽

E Dagli ◽

...

Keyword(s):

Allergic Rhinitis ◽

Mucociliary Clearance ◽

Isotonic Saline ◽

Sodium Hyaluronate ◽

Controlled Study ◽

Control Group ◽

Clearance Time ◽

Nasal Irrigation ◽

Persistent Allergic Rhinitis ◽

Randomised Controlled

Abstract Objective To investigate the effects of nasal irrigation with sodium hyaluronate and surfactant solutions on mucociliary clearance time in patients with mild persistent allergic rhinitis. Methods A total of 120 patients diagnosed with mild persistent allergic rhinitis were enrolled in this prospective study. The patients were allocated randomly to the surfactant, sodium hyaluronate or isotonic saline (as a control) nasal irrigation group. The mucociliary clearance times and improvements in mucociliary clearance times were compared. Results Improvements in mean mucociliary clearance time were significantly greater in the surfactant and sodium hyaluronate groups than in the control group (p < 0.01). The mean post-treatment mucociliary clearance time of the surfactant group was significantly lower than that of the control (p < 0.001) and sodium hyaluronate groups (p = 0.03). Conclusion Surfactant and sodium hyaluronate nasal irrigation solutions may both be used as adjunctive treatments for allergic rhinitis. Surfactant nasal irrigation resulted in better mucociliary clearance times.

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Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES)

BMJ Open ◽

10.1136/bmjopen-2020-043699 ◽

2021 ◽

Vol 11 (1) ◽

pp. e043699

Author(s):

Morten Riemenschneider ◽

Lars G Hvid ◽

Steffen Ringgaard ◽

Mikkel K E Nygaard ◽

Simon F Eskildsen ◽

...

Keyword(s):

Multiple Sclerosis ◽

Randomised Controlled Trial ◽

Usual Care ◽

Treatment Strategy ◽

Controlled Trial ◽

Treatment Strategies ◽

Control Group ◽

Disease Course ◽

Disability Progression ◽

Randomised Controlled

IntroductionIn the relapsing remitting type of multiple sclerosis (MS) reducing relapses and neurodegeneration is crucial in halting the long-term impact of the disease. Medical disease-modifying treatments have proven effective, especially when introduced early in the disease course. However, patients still experience disease activity and disability progression, and therefore, supplemental early treatment strategies are warranted. Exercise appear to be one of the most promising supplemental treatment strategies, but a somewhat overlooked ‘window of opportunity’ exist early in the disease course. The objective of this study is to investigate exercise as a supplementary treatment strategy early in the disease course of MS.Methods and analysisThe presented Early Multiple Sclerosis Exercise Study is a 48-week (plus 1-year follow-up) national multicentre single-blinded parallel group randomised controlled trial comparing two groups receiving usual care plus supervised high-intense exercise or plus health education (active control). Additionally, data will be compared with a population-based control group receiving usual care only obtained from the Danish MS Registry. The primary outcomes are annual relapse rate and MRI derived global brain atrophy. The secondary outcomes are disability progression, physical and cognitive function, MS-related symptoms, and exploratory MRI outcomes. All analyses will be performed as intention to treat.Ethics and disseminationThe study is approved by The Central Denmark Region Committees on Health Research Ethics (1-10-72-388-17) and registered at the Danish Data Protection Agency (2016-051-000001 (706)). All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.Trial registration numberNCT03322761.

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Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis

BMJ Open ◽

10.1136/bmjopen-2017-016966 ◽

2017 ◽

Vol 7 (9) ◽

pp. e016966 ◽

Cited By ~ 13

Author(s):

Sarah Thomas ◽

Louise Fazakarley ◽

Peter W Thomas ◽

Sarah Collyer ◽

Sarah Brenton ◽

...

Keyword(s):

Physical Activity ◽

Multiple Sclerosis ◽

Controlled Trial ◽

Well Being ◽

Recruitment Rate ◽

Controlled Study ◽

Activity Levels ◽

Nintendo Wii ◽

Serious Adverse Events ◽

Randomised Controlled

ObjectivesWhile the health and well-being benefits of physical activity are recognised, people with multiple sclerosis (MS) often face greater barriers than the general population. The Nintendo Wii potentially offers a fun, convenient way of overcoming some of these. The aim was to test the feasibility of conducting a definitive trial of the effectiveness and cost-effectiveness of Mii-vitaliSe; a home-based, physiotherapist-supported Nintendo Wii intervention.DesignA single-centre wait-list randomised controlled study.SettingMS service in secondary care.ParticipantsAmbulatory, relatively inactive people with clinically confirmed MS.InterventionThirty participants were randomised to receive Mii-vitaliSe either immediately (for 12 months) or after a 6-month wait (for 6 months). Mii-vitaliSe consisted of two supervised Nintendo Wii familiarisation sessions in the hospital followed by home use (Wii Sports, Sports Resort and Fit Plus software) with physiotherapist support and personalised resources.OutcomesIncluded self-reported physical activity levels, quality of life, mood, self-efficacy, fatigue and assessments of balance, gait, mobility and hand dexterity at baseline, 6 and 12 months. Interviews (n=25) explored participants’ experiences and, at study end, the two Mii-vitaliSe facilitators’ experiences of intervention delivery (main qualitative findings reported separately).ResultsMean (SD) age was 49.3 (8.7) years, 90% female, with 47% diagnosed with MS <6 years ago and 60% new to active gaming. The recruitment rate was 31% (95% CI 20% to 44%). Outcome data were available for 29 (97%) at 6 months and 28 (93%) at 12 months. No serious adverse events were reported during the study. Qualitative data indicated that Mii-vitaliSe was well-received. Mean Wii use across both groups over the initial 6-month intervention period was twice a week for 27 min/day. Mean cost of delivering Mii-vitaliSe was £684 per person.DiscussionMii-vitaliSe appears acceptable and a future trial feasible and warranted. These findings will inform its design.Trial registrationISRCTN49286846

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