ThinkingFit: Combined Physical, Cognitive and Social Treatment in Mild Cognitive Impairment (MCI)
| Tracking Information | |||||
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| First Received Date ICMJE | May 17, 2012 | ||||
| Last Updated Date | May 20, 2012 | ||||
| Start Date ICMJE | January 2010 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Activity Compliance [ Time Frame: Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks ] [ Designated as safety issue: No ] Number of participants to have completed 50% or more of the programmed activity sessions during the intervention period. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01603862 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | ThinkingFit: Combined Physical, Cognitive and Social Treatment in Mild Cognitive Impairment (MCI) | ||||
| Official Title ICMJE | Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Mild Cognitive Impairment | ||||
| Intervention ICMJE | Procedure: ThinkingFit programme
Combined physical, cognitive and social stimulation activties.
Other Name: ThinkingFit Programme |
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| Study Arm (s) | Experimental: ThinkingFit
Intervention: Procedure: ThinkingFit programme |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 128 | ||||
| Estimated Completion Date | August 2012 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria for patients with MCI
Exclusion Criteria: Exclusion criteria for patients with MCI
Participants with modifiable exclusion criteria will be reconsidered after successful management. Patients will be referred for medical treatment prior to commencing exercise if indicated by the PARQ and the intervention will be guided by the PARmedX. Participants taking medications affecting heart rate will need to be on a stable dosing regime for 3 months prior to commencing in order to control for potential spurious results on fitness measures caused by these treatments. |
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| Gender | Both | ||||
| Ages | 40 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01603862 | ||||
| Other Study ID Numbers ICMJE | ThinkingFit 1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr Thomas Dannhauser, North Essex Partnership NHS Foundation Trust | ||||
| Study Sponsor ICMJE | Dr Thomas Dannhauser | ||||
| Collaborators ICMJE | University College, London | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | North Essex Partnership NHS Foundation Trust | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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