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Study of the effectiveness of hippotherapy on the symptoms of multiple sclerosis - Outline of a randomised controlled multicentre study (MS-HIPPO).

ABSTRACT: Hippotherapy is a form of therapeutic riding which is used in the treatment of neurological and muscular disorders. Until now there has not been any high-quality randomised study that has proven its effectiveness.The aims of this study are to evaluate whether hippotherapy (as add-on to physiotherapy and/or pharmacotherapy) is superior to the standard treatment (physiotherapy and/or pharmacotherapy as prior to the study) in terms of balance function and other patient relevant outcomes in patients with multiple sclerosis.The MS-HIPPO study is a prospective, randomised, examiner-blinded, controlled multicentre study. Patients were randomised to one of two groups: 12 weeks of hippotherapy accompanied by physiotherapy and/or pharmacotherapy (intervention) or 12 weeks of physiotherapy and/or pharmacotherapy as prior to the study (control). The primary endpoint is the change in balance function, as measured by the Berg Balance Scale (BBS). The treatment comparison is evaluated using a covariance analysis with baseline BBS, centre, age, gender and EDSS as covariates. Secondary endpoints include fatigue, quality of life, pain intensity and spasticity.The described study is the first randomised study evaluating the benefits of hippotherapy for patients with multiple sclerosis. In 5 national centres ten study physicians will screen potential participants. The expected results will help to improve the knowledge on non-pharmaceutical therapeutic options in this field.

SUBMITTER: Wollenweber V

PROVIDER: S-EPMC5935848 | biostudies-other | 2016 Aug

REPOSITORIES: biostudies-other

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Study of the effectiveness of hippotherapy on the symptoms of multiple sclerosis - Outline of a randomised controlled multicentre study (MS-HIPPO).

Wollenweber Vanessa V Drache Marion M Schickendantz Sabine S Gerber-Grote Andreas A Schiller Petra P Pöhlau Dieter D

Contemporary clinical trials communications 20160218

<h4>Background</h4>Hippotherapy is a form of therapeutic riding which is used in the treatment of neurological and muscular disorders. Until now there has not been any high-quality randomised study that has proven its effectiveness.<h4>Objective</h4>The aims of this study are to evaluate whether hippotherapy (as add-on to physiotherapy and/or pharmacotherapy) is superior to the standard treatment (physiotherapy and/or pharmacotherapy as prior to the study) in terms of balance function and other ...[more]

PMID: 29736452

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Project description:BACKGROUND:Multiple sclerosis (MS) is a chronic, degenerative disease of the central nervous system. Because of the long-term and unpredictable nature of the disease, the burden of MS is significant from both a patient and societal perspective. Despite a recent influx of disease-modifying therapies to treat MS, many individuals continue to experience disability that negatively affects productivity and quality of life. Previous research indicates that physical activity has a positive impact on walking function in individuals with MS, in addition to the usual beneficial effects on overall health. However, most people with MS are not active enough to gain these benefits, and a lack of support to initiate and maintain physical activity has been identified as a major barrier. This study will evaluate the impact of a novel intervention involving individualised behaviour change strategies delivered by neurophysiotherapists on increasing physical activity levels in individuals with MS who are currently inactive. METHODS/DESIGN:This single-blind, parallel-group, randomised controlled trial will be conducted in Saskatchewan, Canada. Eligible participants include individuals with MS who are ambulatory but identified as currently inactive by the self-reported Godin Leisure-Time Exercise Questionnaire (GLTEQ). The intervention will be delivered by neurophysiotherapists and includes individualised behaviour change strategies aimed at increasing physical activity over a 12-month period. The control group will receive usual care during the 12-month study period. The primary outcome is the change in physical activity level, as measured by the change in the GLTEQ score from baseline to 12?months. Secondary outcomes include the change in patient-reported outcome measures assessing MS-specific symptoms, confidence and quality of life. DISCUSSION:Physical activity has been identified as a top research priority by the MS community. Findings from this novel study may result in new knowledge that could significantly impact the management and overall health of individuals with MS. TRIAL REGISTRATION:ClinicalTrials.gov, NCT04027114. Registered on 10 July 2019.

Project description:IntroductionAlthough physical activity may reduce disease burden, fatigue and disability, and improve quality of life among people with multiple sclerosis (MS), many people with MS are physically inactive and spend significant time in sedentary behaviour. Behaviour change interventions may assist people with MS to increase physical activity and reduce sedentary behaviour. However, few studies have investigated their effectiveness using objective measures of physical activity, particularly in the long term. Further, interventions that have proven effective in the short term may not be feasible in clinical practice because of the large amount of support provided. The iStep-MS trial aims to determine the safety, feasibility and acceptability of a behaviour change intervention to increase physical activity and reduce sedentary behaviour among people with MS.Methods and analysisSixty people with MS will be randomised (1:1 ratio) to receive a 12-week intervention or usual care only. The intervention consists of four physical activity consultations with a physiotherapist supported by a handbook and pedometer. Outcomes assessed at baseline, 12 weeks and 9 months are physical activity (ActiGraph wGT3X-BT accelerometer), sedentary behaviour (activPAL3µ), self-reported activity and sitting time, walking capability, fatigue, self-efficacy, participation, quality of life and health service use. The safety of the intervention will be determined by assessing change in pain and fatigue and the incidence of adverse events during the follow-up period. A parallel process evaluation will assess the feasibility and acceptability of the intervention through assessment of fidelity to the programme and semistructured interviews exploring participants' and therapists' experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on quality of life and resource use.Ethics and disseminationResearch ethics committee approval has been granted from Brunel University London. Results of the trial will be submitted for publication in journals and distributed to people with MS and physiotherapists.Trial registration numberISRCTN15343862 (doi 10.1186/ISRCTN15343862). Protocol version: 1.0; Pre-results.

Project description:INTRODUCTION:Although exercise therapy has widely been shown to be an efficacious treatment modality for depression, evidence for its effectiveness and cost efficiency is lacking. The Sport/Exercise Therapy for Depression study is a multicentre cluster-randomised effectiveness trial that aims to compare the effectiveness and cost efficiency of exercise therapy and psychotherapy as antidepressant treatment. METHODS AND ANALYSIS:480 patients (aged 18-65) with an International Classification of Diseases diagnosis associated with depressive symptoms are recruited. Up to 30 clusters (psychotherapists) are randomly assigned to allocate patients to either an exercise or a psychotherapy treatment as usual in a 2:1 ratio. The primary outcome (depressive symptoms) and the secondary outcomes (work and social adjustment, quality of life) will be assessed at six measurement time points (t0: baseline, t1: 8 weeks after treatment initiation, t2: 16 weeks after treatment initiation, t3/4/5: 2, 6, 12 months after treatment). Linear regression analyses will be used for the primary endpoint data analysis. For the secondary endpoints, mixed linear and logistic regression models with fixed and random factors will be added. For the cost efficiency analysis, expenditures in the 12 months before and after the intervention and the outcome difference will be compared between groups in a multilevel model. Recruitment start date was 1 July 2018 and the planned recruitment end date is 31 December 2020. ETHICS AND DISSEMINATION:The study protocol was approved by the ethics committee of the University of Potsdam (No. 17/2018) and the Freie Universität Berlin (No. 206/2018) and registered in the ISRCTN registry. Informed written consent will be obtained from all participants. The study will be reported in accordance with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials statements. The results will be published in peer-reviewed academic journals and disseminated to the public. TRIAL REGISTRATION NUMBER:ISRCTN28972230.

Project description:INTRODUCTION:Many studies have explored the impact of lifestyle interventions on depression. However, little is known about the effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression. Our objective is to assess the effectiveness of complex multiple-risk lifestyle interventions in reducing depressive symptoms in the adult population by the acquisition of at least two healthy habits-healthy diet, physical activity and/or smoking cessation. For such purpose, a systematic review and meta-analysis of randomised controlled trials will be conducted. METHOD AND ANALYSIS:MEDLINE (through Ovid and PubMed), Scopus, Cochrane Central Register of Controlled Trials, Web of Science, PsycINFO, OpenGrey Register (System for Information on Grey Literature in Europe) and the International Clinical Trials Registry Platform will be searched for relevant articles. Additionally, a supplementary manual search will be performed using lists of references, references to expert authors and other systematic reviews and/or meta-analyses. Study selection, data extraction (target habits, country, target populations, conditions and statistical data to name a few) and assessment of the risk of bias will be performed separately by two independent researchers. The primary outcome measure will be the reduction of depression symptoms, as measured by validated instruments. We will calculate pooled standardised mean differences and 95% CIs using random-effect models. Heterogeneity, sensitivity and publication bias will be assessed, and sub-group analysis will be performed. Heterogeneity will be explored by random-effects meta-regression analysis. ETHICS AND DISSEMINATION:Ethical approval is not required for this study. The results of this systematic review and meta-analysis will be presented in relevant conferences and published in a peer-review journal. The findings of this study could have important clinical and scientific implications for the improvement of symptoms of depression. PROSPERO REGISTRATION NUMBER:CRD42018100253; Pre-results.

Project description:This is a multi-centre, case-controlled study to develop a dataset containing 1000 MS cases and 1000 matched controls and to associate DNA sequence (allelic) variations with MS phenotypes. Study subjects were enrolled through a prospective effort initiated in 2003. Three MS clinical centres were involved in subject recruitment and biological specimen collection using identical inclusion/exclusion criteria, two in Europe (Vrije Universiteit Medical Center, Amsterdam; and University Hospital Basel) and one in the US (University of California San Francisco). This study recruited subjects of northern-European ancestry with a diagnosis of MS (<a href="http://www.ncbi.nlm.nih.gov/pubmed/11456302" target="_blank">McDonald et al., 2001</a>), with dissemination in time and space. Patients with Clinically Isolated Syndromes (CIS) were also included if they fulfilled 3 of the 4 Barkhof criteria for dissemination in space as per application of the McDonald criteria (<a href="http://www.ncbi.nlm.nih.gov/pubmed/11456302" target="_blank">McDonald et al., 2001</a>). While recruitment predominantly included subjects with a relapsing onset of MS, individuals with all clinical subtypes of the disease participated, including clinically isolated syndrome (CIS), relapsing remitting MS (RRMS), secondary progressive MS (SPMS), primary progressive MS (PPMS), and progressive relapsing MS (PRMS). The control group consisted of unrelated individuals, primarily spouses/partners, friends, and other volunteers. Control subjects were of northern-European ancestry and matched as a group, proportionally with cases according to age (±5 years) and gender. A familial history or current diagnosis of MS as well as a relation to another case or control subject were considered exclusionary for this group. Protocols were approved by the Committees on Human Research at all Institutions and informed consent was obtained from all participants prior to participation in the study. Primary Study Objective: To identify DNA sequence variations (genotype) and flanking sequences that are associated with clinical factors (phenotype) which differ between study subjects with and without MS. Secondary Study Objectives: <ol> <li>To develop a clinical dataset including quantitative measures of 1000 well-characterized cases with MS, and 1000 ethnically matched controls.</li> <li>To identify other genotype-phenotype associations in MS study subjects such as magnetic resonance imaging (MRI) measures of disease burden and/or severity.</li> <li>To identify or confirm candidate surrogate markers of neurodegeneration using a variety of techniques including biochemical assays, blood transcriptome analysis, plasma proteomics and MRI*.</li> </ol> Genotyping Genotyping of the complete dataset was performed at the Illumina facilities using the Sentrix® HumanHap550 BeadChip. *MRI results are not available on dbGaP.

Dataset Information

Study of the effectiveness of hippotherapy on the symptoms of multiple sclerosis - Outline of a randomised controlled multicentre study (MS-HIPPO).

Publications

Study of the effectiveness of hippotherapy on the symptoms of multiple sclerosis - Outline of a randomised controlled multicentre study (MS-HIPPO).

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