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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01603862
First Posted: May 23, 2012
Last Update Posted: April 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University College, London
Information provided by (Responsible Party):
Dr Thomas Dannhauser, North Essex Partnership NHS Foundation Trust
  Purpose

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 Intervention
Mild Cognitive Impairment Procedure: ThinkingFit programme

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Dr Thomas Dannhauser, North Essex Partnership NHS Foundation Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 128
Study Start Date: January 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ThinkingFit Procedure: ThinkingFit programme
Combined physical, cognitive and social stimulation activties.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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.

  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United Kingdom
North Essex Partnership Foundation NHS Trust
Harlow, Essex, United Kingdom, cm20 1qx
Sponsors and Collaborators
Dr Thomas Dannhauser
University College, London
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Thomas Dannhauser, Consultant Psychiatrist and Honorary Senior Lecturer in Psychiatry, North Essex Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01603862     History of Changes
Other Study ID Numbers: ThinkingFit 1
First Submitted: May 17, 2012
First Posted: May 23, 2012
Last Update Posted: April 28, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders