Mild Cognitive ImpairmentThinkingFitNCT01603862
ThinkingFit: Combined Physical, Cognitive and Social Treatment in Mild Cognitive Impairment (MCI)
A study testing ThinkingFit programme in people with Mild Cognitive Impairment, run by Dr Thomas Dannhauser at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- ThinkingFit programme
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fulfilling criteria for AMCI [Petersen et al. 2001b]:
- Memory impairment for age and education ii. No impairment in other cognitive domains iii. Normal social activities iv. Patient is not demented
- For the other subtypes of MCI, cognitive impairment in one or more nonmemory domain
- 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.
- Willing and able to give informed consent.
- Availability and access to safe exercise environments, such as paths or roads with sidewalks for walking or cycling.
- At low risk from serious adverse effects from increased physical activity as indicated by performance on the revised Physical activity readiness questionnaire (PARQ).
Who cannot join
- Type 1 (insulin dependent) diabetes mellitus.
- Blood pressure of 160/100 mmHg or more.
- Body weight more than 140% of ideal body weight.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North Essex Partnership Foundation NHS Trust
Harlow, Essex, cm20 1qx
About this study
Official title: Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in Mild Cognitive Impairment
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
- Being tested
- ThinkingFit programme
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThinkingFit programmeProcedure or surgery
Combined physical, cognitive and social stimulation activties.
| Study group | Role | What they receive |
|---|---|---|
| ThinkingFit | Experimental | Not described Receives: Procedure: ThinkingFit programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Compliance
Number of participants to have completed 50% or more of the programmed activity sessions during the intervention period.
Measured: Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks
Secondary outcomes (3)
Cardiovascular fitness measure
Cardiovascular fitness will be measured with a modified Siconolfi Step Test.
Measured: This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
Cognitive measures
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
Measured: This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
Measures of quality of life and everyday activities
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)
Measured: This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startJan 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Thomas Dannhauser
- Sponsor type
- Other government
- Collaborators
- University College, London
- Responsible party
- Sponsor-investigator, Dr Thomas Dannhauser, North Essex Partnership NHS Foundation Trust
- Investigators
- Martin Cleverley, Principal investigator, North Essex Partnership Foundation NHS TrustThomas M Dannhauser, PhD, Study director, University College London, North Essex Partnership NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603862
- Sponsor's protocol ID
- ThinkingFit 1
- Acronym
- ThinkingFit
- Status last verified
- Apr 2014
- First submitted
- 17 May 2012
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24886353
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01603862
- Acronym / sponsor ID
- ThinkingFit / ThinkingFit 1
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Dr Thomas DannhauserOther government
- Collaborators
- University College, London
- Study start
- Jan 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ThinkingFit | Experimental | Procedure: ThinkingFit programme |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients fulfilling criteria for AMCI [Petersen et al. 2001b]:
- For the other subtypes of MCI, cognitive impairment in one or more nonmemory domain
- 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.
- Willing and able to give informed consent.
- Availability and access to safe exercise environments, such as paths or roads with sidewalks for walking or cycling.
Key exclusion criteria (6 listed)
- Type 1 (insulin dependent) diabetes mellitus.
- Blood pressure of 160/100 mmHg or more.
- Body weight more than 140% of ideal body weight.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThinkingFit programmeCombined physical, cognitive and social stimulation activties. | Procedure or surgery | ThinkingFit |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
- Derived from this study: PubMed 24886353Dannhauser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Cleverley principal investigator
North Essex Partnership Foundation NHS Trust
Thomas M Dannhauser, PhD study director
University College London, North Essex Partnership NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ThinkingFit programme in people with Mild Cognitive Impairment, run by Dr Thomas Dannhauser at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity Compliance (time frame: Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01603862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014.