ThinkingFit: Combined Physical, Cognitive and Social Treatment in Mild Cognitive Impairment (MCI) (ThinkingFit)
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|ClinicalTrials.gov Identifier: NCT01603862|
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : April 28, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Procedure: ThinkingFit programme||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in Mild Cognitive Impairment|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Procedure: ThinkingFit programme
Combined physical, cognitive and social stimulation activties.
- Activity Compliance [ Time Frame: Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks ]Number of participants to have completed 50% or more of the programmed activity sessions during the intervention period.
- Cardiovascular fitness measure [ Time Frame: This 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 measures [ Time Frame: This 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 activities [ Time Frame: This 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603862
|North Essex Partnership Foundation NHS Trust|
|Harlow, Essex, United Kingdom, cm20 1qx|
|Principal Investigator:||Martin Cleverley||North Essex Partnership Foundation NHS Trust|
|Study Director:||Thomas M Dannhauser, PhD||University College London, North Essex Partnership NHS Foundation Trust|