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

NCT ID: NCT01603862

Last Updated: 2014-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-11-30

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ThinkingFit

Group Type: EXPERIMENTAL

ThinkingFit programme

Intervention Type: PROCEDURE

Combined physical, cognitive and social stimulation activties.

Interventions

ThinkingFit programme

Combined physical, cognitive and social stimulation activties.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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).

Exclusion Criteria

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 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: collaborator

Dr Thomas Dannhauser

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr Thomas Dannhauser

Consultant Psychiatrist and Honorary Senior Lecturer in Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Martin Cleverley

Role: PRINCIPAL_INVESTIGATOR

North Essex Partnership Foundation NHS Trust

Thomas M Dannhauser, PhD

Role: STUDY_DIRECTOR

University College London, North Essex Partnership NHS Foundation Trust

Locations

North Essex Partnership Foundation NHS Trust

Harlow, Essex, United Kingdom

Countries

United Kingdom

References

Dannhauser TM, Cleverley M, Whitfield TJ, Fletcher BC, Stevens T, Walker Z. A complex multimodal activity intervention to reduce the risk of dementia in mild cognitive impairment--ThinkingFit: pilot and feasibility study for a randomized controlled trial. BMC Psychiatry. 2014 May 5;14:129. doi: 10.1186/1471-244X-14-129.

Reference Type: DERIVED

PMID: 24886353 (View on PubMed)

Other Identifiers

ThinkingFit 1

Identifier Type: -

Identifier Source: org_study_id