Pilot of Cognitive Stimulation Therapy for Pre-frail Stroke Survivors
NCT06733103 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-12-03
Summary
Frailty is described as a type of vulnerability where one can struggle to recover fully from things that can put stress on one\'s body, e.g., cold weather or bronchitis. This can lead to negative health outcomes and is linked with early death, particularly if the person has had a stroke. Frailty was first operationalised by Fried et al. (2001) as the presence of at least three out of the following five clinical indicators: unintentional weight loss, exhaustion, weakness, slow walking speed and low level of physical activity. They also defined 'intermediate frailty status\', now referred to as \'pre-frailty', as the occurrence of one or two of the five criteria.
An alternative perspective on frailty was proposed by Mitnitski et al. (2001), suggesting it refers to the number of health deficits an individual has accumulated. Individuals assessed as pre-frail have an increased risk of becoming frail in the following few years, and those assessed as frail are more likely to die (Gill et al., 2006). However, frailty is potentially reversible at the pre-frail stage, making pre-frailty an important target for intervention (Gill et al., 2006).
A promising approach to the reversal of pre-frailty is multicomponent interventions consisting of a physical exercise intervention combined with nutritional, cognitive, social and/or other interventions, which have been shown to reduce frailty ratings in pre-frail older adults (aged 65 or above) (Apóstolo et al., 2018; Dedeyne et al., 2017; Tam et al., 2022).
Interestingly, cognitive training interventions alone can also have a positive impact on frailty ratings (Ng et al., 2015), indicating a potential role for psychologically informed interventions in frailty management. If multicomponent interventions reverse frailty in pre-frail older adult populations, it is possible they may also reverse frailty in pre-frail stroke populations and help to reduce the risk of associated adverse outcomes.
There is limited consistency across the existing literature of multicomponent interventions regarding the mode of delivery, content, and duration of the cognitive component (e.g. Apóstolo et al., 2019; Chen et al., 2020; Murukesu et al., 2020; Ng et al., 2015). However, some formats of the cognitive interventions used share similarities with Cognitive Stimulation Therapy (CST; Spector et al., 2003). CST is an intervention for individuals with mild to moderate dementia and is recommended by the National Institute of Health and Care Excellence \[NICE\] (2018); it has been researched globally and found to improve cognition, quality of life, well-being, mood and activities of daily living (Aguirre et al., 2013; Lobbia et al., 2019).
CST might, therefore, provide a good basis for the cognitive training component of a multicomponent frailty intervention, including within stroke populations. However, there is currently no research applying CST in a population where stroke is the primary diagnosis. We therefore want to find out if an adapted version of CST will be a feasible and acceptable intervention for stroke survivors and their informal carers, who have been found to spend over 30 hours per week supporting the stroke survivor (Deloitte Access Economics, 2020).
The thoughts of the stroke survivors (who will have attended the pilot group intervention) and their carers (who will have not attended the intervention but will have supported the stroke survivor to attend and complete between session activities) will be gathered from focus groups. We will explore their thoughts on the feasibility and acceptability of the intervention (fore example, whether it can be reasonably carried out and is felt to be appropriate).
This study is part of a larger research project on Frailty and its Effects on Stroke Treatments and Outcomes (FIESTO) and the findings will inform the neuropsychological component used in a feasibility randomised control trial investigating a multicomponent intervention for pre-frail stroke survivors.
Conditions
Interventions
- BEHAVIORAL
-
Stroke Cognitive Behavioural Therapy
This is the only intervention in this clinical (feasibility) study
Sponsors & Collaborators
-
Cambridge University Hospitals NHS Foundation Trust
collaborator OTHER -
University of East Anglia
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-07-09
- Primary Completion
- 2024-10-04
- Completion
- 2024-10-04
Countries
- United Kingdom
Study Locations
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