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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Procedure: ThinkingFit programme

• Registration Number: NCT01603862
• Lead Sponsor: Dr Thomas Dannhauser

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-20
• Study First Posted: 2012-05-23
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-25
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

Exclusion Criteria

Exclusion criteria for patients with MCI

1. Type 1 (insulin dependent) diabetes mellitus.
2. Blood pressure of 160/100 mmHg or more.
3. Body weight more than 140% of ideal body weight.
4. Musculoskeletal or other medical problems preventing safe participation in regular moderate intensity exercise (65-77% of predicted maximum heart rate). This will include a resting tachycardia (heart rate above 100 bpm) and history of myocardial infarction or unstable angina within the last month.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ThinkingFit	ThinkingFit programme	-

Primary Outcome Measures

Name	Time	Method
Activity Compliance	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.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular fitness measure	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	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	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)

Trial Locations

Locations (1)

North Essex Partnership Foundation NHS Trust; 🇬🇧 Harlow, Essex, United Kingdom