Please select the eligibility criteria that correspond to the clinical trial below.
Title: Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in Mild Cognitive Impairment
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.


Options:
A: Inclusion Criteria:

* aged 60-77 years
* dementia Risk Score 6 points or more
* fulfillment of at least one of the following CERAD criteria: i) MMSE: 20-26 points ii) word list memory task (3x10 words): 19 words or less iii) delayed recall: 75% or less

Exclusion Criteria:

* malignant diseases
* dementia
* substantial cognitive decline
* major depression
* symptomatic cardiovascular disease
* revascularisation within 1 year
* severe loss of vision, hearing or communicative ability
* other conditions inhibiting from safe engagement in the prescribed intervention as judged by the study physician
* other conditions preventing from cooperation as judged by the study physician
B: Inclusion Criteria:

* Age 70 to 85 years
* Summary score between 88 (80 for less than 8 years of education) and 95 on the Modified Mini-Mental Exam
* Sedentary lifestyle, i.e., not actively participating in a formal exercise program within the past 3 months (defined as 30 minutes or more of formal exercise at least once a week; brisk walks will be considered formal exercise, leisurely walks will not)
* Fluency in standard American English (to limit staffing and translation costs in this pilot)
* Willingness to be randomized to any of the four intervention conditions

Exclusion Criteria:

* Failure to provide the name of a personal physician
* Living in a nursing home; persons living in assisted or independent housing will not be excluded
* Unable to communicate because of severe hearing loss or speech disorder
* Severe visual impairment, which would preclude completion of the assessments and/or intervention
* Neurologic disease, e.g. Alzheimer's (or other types of dementia), stroke that required hospitalization, Parkinson's, multiple sclerosis, amyotrophic lateral sclerosis, or prior diagnosis of mild cognitive impairment (MCI)
* Abnormal functioning based on the modified Telephone Interview for Cognitive Status (less than 30)
* Positive screen for MCI or dementia
* Scores greater than or equal to 1.5 standard deviations below normal on memory and non-memory domain tests (speed of processing, and verbal fluency)
* Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease
* Terminal illness with life expectancy less than 8 months, as determined by a physician
* Severe pulmonary disease, e.g., on home oxygen or chronic steroids
* Severe cardiac disease, including New York Health Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest which required resuscitation, use of a cardiac defibrillator, or uncontrolled angina
* Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, severe or acute psychiatric disorder (e.g. bipolar disorder or major depression, schizophrenia), excessive alcohol use (more than 14 drinks per wk); persons with managed depression (on stable dosage for at least 3 months) will not be excluded
* Baseline Geriatric Depression Scale score greater than 6
* Other significant factors that may affect the ability for cognitive training, including a history of head trauma resulting in a loss of consciousness, current use of benzodiazepines, hypnotic or anticholinergic agents, and current use of cognitive enhancing prescription or investigational medications (e.g., donepezil, selegiline, tacrine)
* Member of household is already enrolled
* Lives distant from the study site or is planning to move out of the area in next 3 years or leave the area for more than 3 months during the next year
* History of participation in a cognitive program in the last 2 years (includes research studies involving memory training)
* Myocardial infarction, coronary artery bypass graft, or valve replacement within past 6 months
* Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia
* Pulmonary embolism or deep venous thrombosis within past 6 months
* Stroke, hip fracture, hip or knee replacement, or spinal surgery within past 4 months
* Receiving physical therapy for gait, balance, or other lower extremity training
* Severe hypertension, e.g., systolic blood pressure over 160 mmHg, diastolic blood pressure over 110 mmHg
* Other temporary intervening events, such as sick spouse, bereavement, or recent move
* Participation in another intervention trial; participation in an observational study may be permitted
* Inability to commit to intervention schedule requirements
C: Inclusion Criteria:

1. Age of 65 years or older
2. Living at home
3. Able to walk without personal assistance and no other physical limitations that can limit participation and adherence, particularly to exercise intervention programme
4. Meet criteria for frailty

Operational definition of frailty.

The participants are assessed and classified on the level of frailty by the following measures and criteria:

1. Weight loss
2. Slowness
3. Poor balance and weakness assessed by chair stand test
4. Muscle weakness assessed by hand grip and knee extension strength
5. Exhaustion, fatigue or low endurance
6. Low physical activity

Exclusion Criteria:

1. Member of household already enrolled
2. Dementia or cognitive impairment, major depression or other psychotic disorders
3. Severe audio-visual impairment
4. Progressive, degenerative neurologic disease like Parkinsonism, fits/ epilepsy, etc
5. Rapidly progressive or terminal illness under palliative care with life expectancy less than 12 months
6. History of alcohol abuse or any other substance abuse
7. Severely affect muscle/joint dysfunction resulting in disability
8. Hospital admission in the past 3 months
9. Regular physical training or physiotherapy or current participation in a vigorous exercise or weight-training program more than once per week
10. Undergoing therapeutic diet incompatible with nutritional supplementation
11. In the opinion of research clinician, the intervention is deemed to be potentially hazardous for the subject, such as serious cardiac and pulmonary disease.
D: 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.

Answer: D