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ThinkingFit: Combined Physical, Cognitive and Social Treatment in Mild Cognitive Impairment (MCI)

Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in Mild Cognitive Impairment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01603862
Acronym
ThinkingFit
Enrollment
128
Registered
2012-05-23
Start date
2010-01-31
Completion date
2012-11-30
Last updated
2014-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Brief summary

Dementia is serious problem and around 700 000 people are affected in the UK alone. Currently there is no cure however early diagnosis and effective treatment offers hope for reducing the impact. Dementia sufferers require care due to physical disability, cognitive deficits, social isolation and emotional symptoms (depression). Delaying the onset of dementia will improve quality of life for patients and reduce the cost of residential care (£42 000 per person per year). People with mild cognitive impairment (MCI) are at high risk of developing dementia. They have impaired cognitive abilities, such as memory, but still manage their everyday activities. Studies show that 8 out of 10 people with MCI will have developed dementia 6 years after diagnosis. Regular physical activities and performing a variety of cognitive activities reduce the risk of dementia and improves abilities and quality of life in healthy people. Therefore a combination of these activities may reduce the risk of developing dementia in MCI. The investigators want to see if they can develop a program which combines these activities in a fun and social way that gets people active and keeps them active. The aims are to improve fitness, cognition and quality of life. The investigators plan to use computers and the internet to help with the activities and to make them available to people who are isolated. Physical activity will involve walking from home, cognitive activities will be computer based games and puzzles and socialising will involve regular varied group-based activities. Participants (128) will be recruited from the UCL Derwent Memory Clinic and will complete a 26 week program. They will then be followed up yearly to monitor their progress. The main outcome of the study is engagement in the activities. The investigators will also measure fitness, cognition, quality of life and conversion to dementia.

Interventions

PROCEDUREThinkingFit programme

Combined physical, cognitive and social stimulation activties.

Sponsors

University College, London
CollaboratorOTHER
Dr Thomas Dannhauser
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

for patients with MCI 1. Patients fulfilling criteria for AMCI \[Petersen et al. 2001b\]: i. Memory impairment for age and education ii. No impairment in other cognitive domains iii. Normal social activities iv. Patient is not demented 2. For the other subtypes of MCI, cognitive impairment in one or more nonmemory domain 3. Sedentary lifestyle with no regular participation in physical exercise defined as two or three times a week for at least 20 minutes duration, or participation in active sport more than once a week, in the previous six months. 4. Willing and able to give informed consent. 5. Availability and access to safe exercise environments, such as paths or roads with sidewalks for walking or cycling. 6. At low risk from serious adverse effects from increased physical activity as indicated by performance on the revised Physical activity readiness questionnaire (PARQ).

Design outcomes

Primary

MeasureTime frameDescription
Activity ComplianceCompliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeksNumber of participants to have completed 50% or more of the programmed activity sessions during the intervention period.

Secondary

MeasureTime frameDescription
Cardiovascular fitness measureThis will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.Cardiovascular fitness will be measured with a modified Siconolfi Step Test.
Cognitive measuresThis will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.Participants will complete the following cognitive measures: * Visual and auditory divided attention task * Verbal episodic encoding and recognition task * Halstead Trail Making test (TMT) * Verbal fluency * Working memory tests: digit span forwards/ backwards
Measures of quality of life and everyday activitiesThis will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.Quality of life will be measured on the World Health Organization Quality of Life (WHOQOL) - BREF and change in every day activities on the Alzheimer's Disease Cooperative Study MCI Activities of Daily Living Scale (ADCS-MCI-ADL)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026