Music-based training programmes, such as learning how to play an instrument or sing in a choir, have been suggested as potential interventions for promoting healthy brain ageing in older adults at risk of cognitive decline because of their ability to enhance cognitive functions and potentially promote neuroplasticity. However, there is limited empirical evidence in older adults at risk of dementia, especially that evaluates both piano and singing interventions and their effects on cognition and neuroplasticity. In this protocol, we outline a study to assess the efficacy of keyboard and singing music training programmes on reducing cognitive decline and other outcomes in older adults with Mild Cognitive Impairment (MCI).
This randomised, single-blind, controlled, parallel-group trial aims to enrol 432 individuals with MCI from the community in Sydney, Australia. Participants are randomly allocated to participate in either keyboard lessons, singing lessons or a film discussion control group once a week for 3 months. The primary objective is to assess the effectiveness of two music training programmes (keyboard and choral singing) for enhancing verbal memory after 3 months compared with control. Additionally, we will examine how these music-based interventions affect other aspects of cognition, mood, sleep, overall well-being, markers of brain plasticity and blood biomarkers of Alzheimer’s disease and neurodegeneration. Tertiary objectives are to identify factors that impact the success of the interventions, such as participation rates, engagement levels and key demographic and clinical features. Outcomes are collected at baseline and at 3 and 9 months. The primary endpoint analysis will include all randomised participants to estimate the treatment effect using intention-to-treat principles. Primary and secondary outcomes will be analysed using linear mixed models and effect size measures will be calculated.
This study will be the first robust, randomised controlled trial to assess the potential and relative value of music engagement for cognitive decline in high-risk MCI individuals, as well as broader effects on other markers of mental health, well-being and neurodegeneration. Co-designed with implementation in mind, the music interventions can potentially be delivered within memory clinic or community settings.
The Sydney University Human Research Ethics Committee (2023-026) has approved this protocol. The trial findings will be shared through conferences, publications and media.
Australian and New Zealand Clinical Trials Registry (ACTRN12623000407695), Registered 21/04/2023 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385552
2.02 29/11/2024.
Stroke is a leading cause of death and disability worldwide, with spasticity affecting 4%–42.6% of stroke survivors. Prolonged spasticity can lead to pain, restricted joint mobility and muscle weakness. Current non-pharmacological treatments include physical therapy, orthoses and surgery. Muscle energy techniques (METs) and blood flow restriction training (BFRT) have shown promise in improving muscle function and reducing spasticity. This study aims to investigate the combined effect of MET and BFRT on upper limb motor function in patients with poststroke spasticity.
This study is a single-blind randomised controlled trial involving patients with poststroke spasticity. Participants will be randomly assigned to either the MET+BFRT group or the passive stretching group. Both groups will receive conventional rehabilitation therapy, with additional MET+BFRT or passive stretching interventions. The intervention will last for 6 weeks, with four sessions per week. Primary outcomes include the simplified Fugl-Meyer assessment (FMA) and surface electromyography, while secondary outcomes include the Modified Barthel Index and the Modified Ashworth Scale.
Based on literature data, patients who had a stroke have an average baseline upper limb FMA score of 40 points. Conventional rehabilitation typically improves FMA to 46 points (SD=8). This trial expects an additional 6-point improvement from the intervention. With α=0.05 (two-sided), 90% power (1–β=0.90) and 10% dropout rate, PASS V.11.0 calculation indicates a minimum requirement of 42 participants per group.
Statistical analysis will be conducted using IBM SPSS Statistics V.25. Intention-to-treat analysis will be used to analyse the result, which means the last observation will be used for interpolation when data are missing. Continuous variables will be summarised as mean±SD for normally distributed data or as median and IQRs for non-normally distributed data. Categorical variables will be presented as frequencies and percentages. For continuous variables that meet the criteria of normal distribution and homogeneity of variance, two-way analysis of variance with repeated measures will be applied; for those that do not meet these criteria, the Mann-Whitney U test will be used. Categorical variables will be analysed with the 2 test or Fisher’s exact test.
The study protocol has been approved by the ethics committee of Jiaxing Hospital of Traditional Chinese Medicine (2024-016). Participants will provide written informed consent before inclusion. The results will be disseminated through peer-reviewed journals and conference presentations.
ChiCTR2400085996.