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Progressive supranuclear palsy (PSP) is a devastating neurodegenerative disease characterised by cognitive, behavioural and motor problems. Motor symptoms are highly disabling, while cognitive and behavioural changes have a major impact on carer burden, quality of life and prognosis. Apathy and impulsivity are very common, often coexistent in PSP, and negatively predict survival. In preclinical models and other diseases, apathy and impulsivity are associated with noradrenergic deficits, which can be severe in PSP.
Noradrenaline for Progressive Supranuclear Palsy Syndromes trial is a randomised, double-blind, placebo-controlled, crossover design, Phase IIb clinical trial to evaluate the efficacy and safety of oral atomoxetine for the treatment of cognitive and behavioural changes in PSP. Participants receive atomoxetine 40 mg (10 mg/mL oral solution) once daily or a matched placebo solution, in random order, each for 8 weeks. An ‘informant’, who knows the patient with PSP well, is co-recruited to complete some of the trial outcome measures. Participants remain in the trial for 22 weeks after randomisation. The primary objectives are to assess (1) safety and tolerability and (2) efficacy versus placebo on challenging behaviours as reported in a subscale of the Cambridge Behavioural Inventory. Secondary and exploratory measures relate to cognition, the PSP Rating Scale, mood and potential baseline predictors of individual response to atomoxetine computed from imaging, genetic and cognitive measures at baseline.
The trial was approved by the South Central-Oxford B Research Ethics Committee (REC) and the Medicines and Healthcare products Regulatory Agency (REC reference: 20/SC/0416). Dissemination will include publication in peer-reviewed journals, presentations at academic and public conferences and engagement with patients, the public, policymakers and practitioners.
ISRCTN99462035; DOI:
To (1) synthesise the experiences of people with heart failure and those who care for them concerning participation in physical activity (2) develop a logic model for a future intervention which will support people with heart failure to feel confident and safe in being physically active.
A systematic review and meta-aggregation using Joanna Briggs Institute (JBI) methodology.
MEDLINE, Emcare and PsycINFO databases were searched through until June 2024 inclusively.
Studies with a qualitative design, including qualitative components of mixed-methods studies, which describe experiences of participation in physical activity by adults with chronic heart failure.
Two independent reviewers used standardised methods to search and screen studies. Data extraction included the PROGRESS-Plus items. The JBI checklist for qualitative studies was applied. Meta-aggregation guided by JBI methods was used to synthesise the data. This evidence, along with input from a patient and public involvement group, healthcare professionals and charity organisations, was used to develop a logic model.
We included 28 papers (25 studies) comprising 14 qualitative studies and 11 mixed-method studies describing the perspectives of 483 people with heart failure, 64 carers and 12 healthcare professionals.
The meta-aggregation produced seven synthesised findings describing the impact of physical symptoms, emotional factors, extrinsic factors, access to knowledge, self-motivation and peer/professional motivation and the positive impact of physical activity. The PROGRESS-PLUS tool identified significant inclusivity issues within the studies. The meta-aggregation with relevant contributor input informed behavioural determinants and potential intervention components of a logic model.
This study identifies behavioural determinants that underlie the actions of people with heart failure in their relationship with physical activity and potential intervention components for a novel intervention design to support this population. There is a lack of studies exploring health professionals’ and carers’ perspectives on this topic.
CRD42022342883.
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