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Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial.

ABSTRACT: BACKGROUND: Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i) movement strategy training combined with falls prevention education, (ii) progressive resistance strength training combined with falls prevention education, (iii) a generic life-skills social program (control group). METHODS/DESIGN: People with idiopathic Parkinson's disease who live at home will be recruited and randomly allocated to one of three groups. Each person shall receive therapy in an out-patient setting in groups of 3-4. Each group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks. All participants will also have a structured 2 hour home practice program for each week during the 8 week intervention phase. Assessments will occur before therapy, after the 8 week therapy program, and at 3 and 12 months after the intervention. A falls calendar will be kept by each participant for 12 months after outpatient therapy.Consistent with the recommendations of the Prevention of Falls Network Europe group, three falls variables will be used as the primary outcome measures: the number of fallers, the number of multiple fallers and the falls rate. In addition to quantifying falls, we shall measure mobility, activity limitations and quality of life as secondary outcomes. DISCUSSION: This study has the potential to determine whether outpatient movement strategy training combined with falls prevention education or progressive resistance strength training combined with falls prevention education are effective for reducing falls and improving mobility and life quality in people with Parkinson's disease who live at home. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12606000344594.

SUBMITTER: Morris ME

PROVIDER: S-EPMC3160881 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial.

Morris Meg E ME Menz Hylton B HB McGinley Jennifer L JL Huxham Frances E FE Murphy Anna T AT Iansek Robert R Danoudis Mary M Soh Sze-Ee SE Kelly David D Watts Jennifer J JJ

BMC neurology 20110731

<h4>Background</h4>Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i) movement strategy training combined with falls prevention education, (ii) progressive resistance strength training combined with falls prevention education, (iii ...[more]

PMID: 21801451

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Project description:INTRODUCTION:The most promising way to promote active life years in old age is to promote regular participation in physical activity (PA). Maintaining lower extremity muscle function with good balance has been associated with fewer falls and the need of help from others. This article describes the design and intervention of a randomised controlled trial (RCT) investigating the effectiveness of a health and PA counselling programme on life-space mobility and falls rates in community-dwelling older adults at the Health Kiosk and/or Service Centre. METHODS AND ANALYSIS:Community-dwelling men and women (n=450) aged 65 years and over with early phase mobility limitation will be recruited to a 24-month RCT with a 24-month follow-up. Participants will be randomly allocated into either a health and PA counselling group (intervention) or relaxation group (control intervention). All participants will receive five group specific face-to-face counselling sessions and 11 phone calls. The counselling intervention will include individualised health counselling, strength and balance training, and guidance to regular PA. The control group will receive relaxation exercises. Outcomes will be assessed at baseline, 12, 24 and 48 months. Primary outcomes are average life-space mobility score and falls rates. Life-space mobility will be assessed by a validated questionnaire. Falls rates will be recorded from fall diaries. Secondary outcomes are data on fall-induced injuries and living arrangements, number of fallers, fracture risk, mean level of PA, physical performance, quality of life, mood, cognition, balance confidence and fear of falling. Data will be analysed using the intention-to-treat principle. Cost-effectiveness of the programme will be analysed. Ancillary analyses are planned in participants with greater adherence. ETHICS AND DISSEMINATION:Ethical approval was obtained from the Ethics Committee of the Tampere University Hospital (R15160). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conferences. TRIAL REGISTRATION:ISRCTN65406039; Pre-results.

Project description:BackgroundHome exercise can prevent falls in the general older community but its impact in people recently discharged from hospital is not known. The study aimed to investigate the effects of a home-based exercise program on falls and mobility among people recently discharged from hospital.Methods and findingsThis randomised controlled trial (ACTRN12607000563460) was conducted among 340 older people. Intervention group participants (n?=?171) were asked to exercise at home for 15-20 minutes up to 6 times weekly for 12 months. The control group (n?=?169) received usual care. Primary outcomes were rate of falls (assessed over 12 months using monthly calendars), performance-based mobility (Lower Extremity Summary Performance Score, range 0-3, at baseline and 12 months, assessor unaware of group allocation) and self-reported ease of mobility task performance (range 0-40, assessed with 12 monthly questionaries). Participants had an average age of 81.2 years (SD 8.0) and 70% had fallen in the past year. Complete primary outcome data were obtained for at least 92% of randomised participants. Participants in the intervention group reported more falls than the control group (177 falls versus 123 falls) during the 12-month study period and this difference was statistically significant (incidence rate ratio 1.43, 95% CI 1.07 to 1.93, p?=?0.017). At 12-months, performance-based mobility had improved significantly more in the intervention group than in the control group (between-group difference adjusted for baseline performance 0.13, 95% CI 0.04 to 0.21, p?=?0.004). Self-reported ease in undertaking mobility tasks over the 12-month period was not significantly different between the groups (0.49, 95% CI -0.91 to 1.90, p?=?0.488).ConclusionsAn individualised home exercise prescription significantly improved performance-based mobility but significantly increased the rate of falls in older people recently discharged from hospital.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12607000563460.

Project description:BackgroundDepressive symptoms are common in patients with Parkinson's disease and depression is a significant predictor of functional impairment, reduced quality of life and general well-being in Parkinson's disease. Despite the high prevalence of depression, evidence on the effectiveness and tolerability of antidepressants in this population is limited. The primary aim of this trial is to establish the clinical and cost effectiveness of escitalopram and nortriptyline for the treatment of depression in Parkinson's disease.MethodsThis is a multi-centre, double-blind, randomised placebo-controlled trial in 408 people with Parkinson's disease with subsyndromal depression, major depressive disorder or persistent depressive disorder and a Beck Depression Inventory-II (BDI-II) score of 14 or above. Participants will be randomised into one of three groups, receiving either escitalopram, nortriptyline or placebo for 12 months. Trial participation is face-to-face, hybrid or remote. The primary outcome measure is the BDI-II score following 8 weeks of treatment. Secondary outcomes will be collected at baseline, 8, 26 and 52 weeks and following withdrawal, including severity of anxiety and depression scores as well as Parkinson's disease motor severity, and ratings of non-motor symptoms, cognitive function, health-related quality of life, levodopa-equivalence dose, changes in medication, overall clinical effectiveness, capability, health and social care resource use, carer health-related quality of life, adverse effects and number of dropouts.DiscussionThis trial aims to determine the effectiveness of escitalopram and nortriptyline for reducing depressive symptoms in Parkinson's disease over 8 weeks, to provide information on the effect of these medications on anxiety and other non-motor symptoms in PD and on impact on patients and caregivers, and to examine their effect on change in motor severity.Trial registrationClinicalTrials.gov Identifier: NCT03652870 Date of registration - 29th August 2018.

Project description:IntroductionThe immune system is implicated in the aetiology and progression of Parkinson's disease (PD). Inflammation and immune activation occur both in the brain and in the periphery, and a proinflammatory cytokine profile is associated with more rapid clinical progression. Furthermore, the risk of developing PD is related to genetic variation in immune-related genes and reduced by the use of immunosuppressant medication. We are therefore conducting a 'proof of concept' trial of azathioprine, an immunosuppressant medication, to investigate whether suppressing the peripheral immune system has a disease-modifying effect in PD.Methods and analysisAZA-PD is a phase II randomised placebo-controlled double-blind trial in early PD. Sixty participants, with clinical markers indicating an elevated risk of disease progression and no inflammatory or immune comorbidity, will be treated (azathioprine:placebo, 1:1) for 12 months, with a further 6-month follow-up. The primary outcome is the change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale gait/axial score in the OFF state over the 12-month treatment period. Exploratory outcomes include additional measures of motor and cognitive function, non-motor symptoms and quality of life. In addition, peripheral and central immune markers will be investigated through analysis of blood, cerebrospinal fluid and PK-11195 positron emission tomography imaging.Ethics and disseminationThe study was approved by the London-Westminster research ethics committee (reference 19/LO/1705) and has been accepted by the Medicines and Healthcare products Regulatory Agency (MHRA) for a clinical trials authorisation (reference CTA 12854/0248/001-0001). In addition, approval has been granted from the Administration of Radioactive Substances Advisory Committee. The results of this trial will be disseminated through publication in scientific journals and presentation at national and international conferences, and a lay summary will be available on our website.Trial registration numbersISRCTN14616801 and EudraCT- 2018-003089-14.

Project description:INTRODUCTION:Parkinson's disease (PD) with mild cognitive impairment (MCI-PD) or dementia (PDD) and dementia with Lewy bodies (DLB) are characterised by motor and 'non-motor' symptoms which impact on quality of life. Treatment options are generally limited to pharmacological approaches. We developed a psychosocial intervention to improve cognition, quality of life and companion burden for people with MCI-PD, PDD or DLB. Here, we describe the protocol for a single-blind randomised controlled trial to assess feasibility, acceptability and tolerability of the intervention and to evaluate treatment implementation. The interaction among the intervention and selected outcome measures and the efficacy of this intervention in improving cognition for people with MCI-PD, PDD or DLB will also be explored. METHODS AND ANALYSIS:Dyads will be randomised into two treatment arms to receive either 'treatment as usual' (TAU) or cognitive stimulation therapy specifically adapted for Parkinson's-related dementias (CST-PD), involving 30?min sessions delivered at home by the study companion three times per week over 10 weeks. A mixed-methods approach will be used to collect data on the operational aspects of the trial and treatment implementation. This will involve diary keeping, telephone follow-ups, dyad checklists and researcher ratings. Analysis will include descriptive statistics summarising recruitment, acceptability and tolerance of the intervention, and treatment implementation. To pilot an outcome measure of efficacy, we will undertake an inferential analysis to test our hypothesis that compared with TAU, CST-PD improves cognition. Qualitative approaches using thematic analysis will also be applied. Our findings will inform a larger definitive trial. ETHICS AND DISSEMINATION:Ethical opinion was granted (REC reference: 15/YH/0531). Findings will be published in peer-reviewed journals and at conferences. We will prepare reports for dissemination by organisations involved with PD and dementia. TRIAL REGISTRATION NUMBER:ISRCTN (ISRCTN11455062).

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Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial.

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Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial.

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