N/A
N=10
Pilot of Cognitive Stimulation Therapy for Pre-frail Stroke Survivors
Stroke · Frailty · Carers
Bottom Line
View on ClinicalTrials.gov: NCT06733103 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Dec 2025
Primary outcome: Primary: Framework Analysis Using the Theoretical Framework of Acceptability as a Guiding Framework — 4; 4; 4; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stroke Cognitive Behavioural Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of East Anglia
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Framework Analysis Using the Theoretical Framework of Acceptability as a Guiding Framework |
4; 4; 4; 4; 4; 4 | — |
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.
Eligibility Criteria
Stroke Survivors Inclusion Criteria:
- 18+ years old
- Had a stroke 12 months ago, or less
- Due to be discharged back home before the adapted CST group starts
- Experiencing a loss of physical resilience as a result of your stroke
- Experiencing some difficulty with your memory or thinking as a result of your stroke
- Have a family member or friend who regularly supports you and is willing to take part in a connected research study
- Have the ability to speak and read the English language to participate fully in the adapted CST group and online interview
Stroke Survivors Exclusion Criteria:
- Have significant difficulties with language, memory or thinking that would take taking part too difficult
- Are not able to independently make the decision about whether you would like to take part
- Have a diagnosis of dementia
- Do not have access to a computer, laptop or tablet from which you can access an online interview
Carers Inclusion Criteria
- Are 18+ years old
- Regularly support someone who has survived a stroke
- Have the ability to speak and read the English language to engage fully in the CST take-home activities and online interview
- Are able to independently make the decision about whether you would like to take part in the study
Carers Exclusion Criteria
- Do not have access to a computer, laptop or tablet from which you can access an online interview
- Are a professional carer for the person you support
- Are being investigated by the safeguarding team
Data sourced from ClinicalTrials.gov (NCT06733103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.