scholarly journals HOMESIDE: home-based family caregiver-delivered music and reading interventions for people living with dementia: protocol of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e031332 ◽  
Author(s):  
Felicity Anne Baker ◽  
Jodie Bloska ◽  
Sabine Braat ◽  
Anna Bukowska ◽  
Imogen Clark ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Psychological Symptoms ◽  
Controlled Trial ◽  
Well Being ◽  
Resource Utilisation ◽  
Home Setting ◽  
Randomised Study ◽  
People With Dementia ◽  
Home Based ◽  
Randomised Controlled

IntroductionPharmacological interventions to address behavioural and psychological symptoms of dementia (BPSD) can have undesirable side effects, therefore non-pharmacological approaches to managing symptoms may be preferable. Past studies show that music therapy can reduce BPSD, and other studies have explored how formal caregivers use music in their caring roles. However, no randomised study has examined the effects on BPSD of music interventions delivered by informal caregivers (CGs) in the home setting. Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs.Methods and analysisA large international three-arm parallel-group randomised controlled trial will recruit a sample of 495 dyads from Australia, Germany, UK, Poland and Norway. Dyads will be randomised equally to standard care (SC), a home-based music programme plus SC, or a home-based reading programme plus SC for 12 weeks. The primary outcome is BPSD of PwD (measured using the Neuropsychiatric Inventory-Questionnaire). Secondary outcomes will examine relationship quality between CG and PwD, depression, resilience, competence, QoL for CG and QoL for PwD. Outcomes will be collected at baseline, at the end of the 12-week intervention and at 6 months post randomisation. Resource Utilisation in Dementia will be used to collect economic data across the life of the intervention and at 6-month follow-up. We hypothesise that the music programme plus SC will generate better results than SC alone (primary comparison) and the reading programme plus SC (secondary comparison).Ethics and disseminationEthical approval has been obtained for all countries. Results will be presented at national and international conferences and published in scientific journals and disseminated to consumer and caregiver representatives and the community.Trial registration numbersACTRN12618001799246p; NCT03907748

scholarly journals Enriched Music-supported Therapy for chronic stroke patients: a study protocol of a randomised controlled trial

BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jennifer Grau-Sánchez ◽  
Emma Segura ◽  
David Sanchez-Pinsach ◽  
Preeti Raghavan ◽  
Thomas F. Münte ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Upper Limb ◽  
Controlled Trial ◽  
Well Being ◽  
Chronic Stroke ◽  
Stroke Patients ◽  
Home Based ◽  
Randomised Controlled

Abstract Background Residual motor deficits of the upper limb in patients with chronic stroke are common and have a negative impact on autonomy, participation and quality of life. Music-Supported Therapy (MST) is an effective intervention to enhance motor and cognitive function, emotional well-being and quality of life in chronic stroke patients. We have adapted the original MST training protocol to a home-based intervention, which incorporates increased training intensity and variability, group sessions, and optimisation of learning to promote autonomy and motivation. Methods A randomised controlled trial will be conducted to test the effectiveness of this enriched MST (eMST) protocol in improving motor functions, cognition, emotional well-being and quality of life of chronic stroke patients when compared to a program of home-based exercises utilizing the Graded Repetitive Arm Supplementary Program (GRASP). Sixty stroke patients will be recruited and randomly allocated to an eMST group (n = 30) or a control GRASP intervention group (n = 30). Patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. The primary outcome of the study is the functionality of the paretic upper limb measured with the Action Research Arm Test. Secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes. Discussion We hypothesize that patients treated with eMST will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based GRASP intervention. Trial registration The trial has been registered at ClinicalTrials.gov and identified as NCT04507542 on 8 August 2020.

scholarly journals Improving Well-being and Health for People with Dementia (WHELD): study protocol for a randomised controlled trial

Trials ◽  
2014 ◽  
Vol 15 (1) ◽  
pp. 284 ◽  
Author(s):  
Rhiannon Whitaker ◽  
Jane Fossey ◽  
Clive Ballard ◽  
Martin Orrell ◽  
Esme Moniz-Cook ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Well Being ◽  
People With Dementia ◽  
Randomised Controlled

Lifestyle integrated functional exercise for people with dementia: study protocol for a home-based randomised controlled trial

2020 ◽  
Vol 27 (5) ◽  
pp. 1-14
Author(s):  
Sara Almeida ◽  
Madalena Gomes da Silva ◽  
Alda Marques
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Step Test ◽  
Control Group ◽  
People With Dementia ◽  
Home Based ◽  
Functional Exercise ◽  
Randomised Controlled

Background/Aims Physical activity is effective in people with dementia. Most people with dementia live at home, but few home-based physical activity programmes have been developed. The aim of this protocol is to determine the feasibility, effectiveness and cost-effectiveness of the Lifestyle Integrated Functional Exercise for People with Dementia (LiFE4D). Methods A randomised, controlled trial will be implemented. The experimental group will receive LiFE4D and the control group will maintain usual treatment. LiFE4D is a 3-month programme adjusted to daily routines and involving carers, with decreased face-to-face contact over time. The primary outcome measure is exercise capacity assessed with the 2-Minute Step Test. Secondary outcomes include cognitive function, physical activity, health-related physical fitness, respiratory function, functionality, quality of life, carers' burden and costs. Results Findings from this study will improve knowledge and provide guidance on home-based physical activity for people with dementia. Conclusions If effective, the trial will provide a model of home-based physical activity and inform international guidelines for dementia care.

scholarly journals Study design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: a cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042850
Author(s):  
Karin Leder ◽  
John J Openshaw ◽  
Pascale Allotey ◽  
Ansariadi Ansariadi ◽  
S Fiona Barker ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Human Health ◽  
Controlled Trial ◽  
Informal Settlements ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Cluster Randomised ◽  
Abundance And Diversity ◽  
Randomised Controlled ◽  
Health And Well Being

IntroductionIncreasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysisRISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.EthicsStudy protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration numberACTRN12618000633280; Pre-results.

scholarly journals Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

2021 ◽  
Author(s):  
Ruth E. Ashton ◽  
Jonathan J. Aning ◽  
Garry A. Tew ◽  
Wendy A Robson ◽  
John M Saxton
Keyword(s):  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Muscular Strength ◽  
Controlled Trial ◽  
Control Group ◽  
Robot Assisted ◽  
Resistance Exercise Training ◽  
Home Based ◽  
Aerobic Exercise Capacity ◽  
Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

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