Back to results

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

Primary Purpose

Mild Cognitive Impairment

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

ThinkingFit programme

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria for patients with MCI

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
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).

Exclusion Criteria:

Exclusion criteria for patients with MCI

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.

Sites / Locations

North Essex Partnership Foundation NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ThinkingFit

Arm Description

Outcomes

Primary Outcome Measures

Activity Compliance

Number of participants to have completed 50% or more of the programmed activity sessions during the intervention period.

Secondary Outcome Measures

Cardiovascular fitness measure

Cardiovascular fitness will be measured with a modified Siconolfi Step Test.

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

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)

Full Information

NCT ID

NCT01603862

First Posted

May 17, 2012

Last Updated

April 25, 2014

Sponsor

Dr Thomas Dannhauser

Collaborators

University College, London

1. Study Identification

Unique Protocol Identification Number

NCT01603862

Brief Title

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

Acronym

ThinkingFit

Official Title

Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in Mild Cognitive Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr Thomas Dannhauser

Collaborators

University College, London

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ThinkingFit

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

ThinkingFit programme

Intervention Description

Combined physical, cognitive and social stimulation activties.

Primary Outcome Measure Information:

Title

Activity Compliance

Description

Number of participants to have completed 50% or more of the programmed activity sessions during the intervention period.

Time Frame

Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks

Secondary Outcome Measure Information:

Title

Cardiovascular fitness measure

Description

Cardiovascular fitness will be measured with a modified Siconolfi Step Test.

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.

Title

Cognitive measures

Description

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.

Title

Measures of quality of life and everyday activities

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria for patients with MCI 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 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). Exclusion Criteria: Exclusion criteria for patients with MCI 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Cleverley

Organizational Affiliation

North Essex Partnership Foundation NHS Trust

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thomas M Dannhauser, PhD

Organizational Affiliation

University College London, North Essex Partnership NHS Foundation Trust

Official's Role

Study Director

Facility Information:

Facility Name

North Essex Partnership Foundation NHS Trust

City

Harlow

State/Province

Essex

ZIP/Postal Code

cm20 1qx

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24886353

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs