Effect of Physical Exercise in Alzheimer Patients

Study Overview
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Brief Summary
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Background: Current treatment for Alzheimer's disease (AD) is symptomatic and can only temporarily slow down progression. Exercise has the potential to improve cognition, psychological symptoms, physical performance and quality of life, but evidence is scarce. Previous trials are short, often underpowered and involving home based light exercise programs. Most have included nursing homes residents with severe or undefined dementia. The aim of the ADEX trial is to establish whether exercise is effective in improving cognition, physical performance and quality of life as well as reducing the prevalence of psychological symptoms among AD patients. Methods: The ADEX Trial is a multicentre, single-blind, randomized clinical trial. Based on power calculations the investigators plan to recruit 192 home-dwelling patients aged 50-90 years with mild to moderate AD. The participants will be randomly allocated into two groups: An intervention group attending 16 weeks of continuously supervised moderate aerobic exercise 1 hour three times a week and a control group only receiving usual care. The hypothesis is that aerobic exercise will improve physical function, the cognitive and daily functioning and quality of life in people with mild to moderate AS. Blood sampling will be performed in all subjects to examine effects on biomarkers. A subgroup of the patients will also undergo MRI, PiB-PET and lumbar puncture to investigate structural changes and β-amyloid accumulation. Further, a health-economic analysis will be performed. Recruitment was started in January 2012. Last study visits are planned to be performed in January 2014 and results will be available in 2014. This RCT will contribute to evidence regarding the potential effects of a systematic program of physical exercise for patients with Alzheimer's disease.

Detailed Description
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see protocol article

Official Title
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Preserving Quality of Life, Physical Health and Functional Ability in Alzheimer's Disease: The Effect of Physical Exercise

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: Aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria are (table 1) Age between 50 and 90 years A score of 20 or more on the Mini Mental State Examination (MMSE) Imaging (CT or MR of cerebrum) consistent with AD Have a caregiver with regular contact to the participant (more than once a month) who is also willing to participate in the study In general good health allowing the participant to participate in physical exercise. At least 7 years of schooling and Danish speaking Visual acuity and hearing must permit neuropsychological testing. If the patient is receiving anti-dementia medication or mood stabilizing medication, these must have been given in stable doses for at least 3 months. Exclusion Criteria: Participation in aerobic exercise (moderate to hard intensity) more than 2 times a week on a regular basis. Any musculoskeletal or joint impairment that could interfere with completion of the study (significant joint problems, back pain or pain in arms and legs that provide problems with mobility in daily activities) Male participants with a combination of two or more of the following risk factors even if asymptomatic: smokers, hypertension and hypercholesterolemia Major neurologic (other than AD), cardiac or other medical diseases that constitutes a contraindication to physical activity. Stent operation or previous myocardial infarction is not an exclusion criteria if the participant has had a recent (within 3 months) normal exercise tests . Severe cerebro vascular disease judged from the CT or MR scans and remarkable hypertension defined as Systolic blood pressure >180 and diastolic >100 Severe psychiatric disease, as well as alcohol or drug abuse within the last 2 years

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>16 weeks of aerobic exercise | Other: Aerobic exercise<br>* Physical exercise in the intervention group will be delivered as an individually tailored program consisting of 4 weeks of adaptation exercise followed by 12 weeks of continuously supervised moderate aerobic exercise 1 hour three times a week. The participants can choose from treadmill, stationary bike and crosstrainer.<br>* Other names: Endurance training;|
| No Intervention: Control group<br>Usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symbol Digit Modalities Test |  | Change in score from baseline to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NPI (psychological symptoms.) |  | Change in score from baseline to 16 weeks | 
| Astrand submaximal bicycle test for estimating VO2 max |  | Change in score from baseline to 16 weeks | 
| Euro-qol-5D-5L (health related quality of life) |  | Change in score from baseline to 16 weeks | 
| Alzheimer's disease Assessment Scale - Cognitive section (ADAS-cog). |  | Change in score from baseline to 16 weeks | 
| Changes in physical fitness | Timed up and go test (TUG), 10 m walk, 10m Dual-Task, 400m fast walking, Sit-to-stand (number in 30 sec.)(STS). | Change in score from baseline to 16 weeks | 
| Self-efficacy scale |  | Change in score from baseline to 16 weeks | 
| Verbal fluency |  | Change in score from baseline to 16 weeks | 
| Stroop |  | Change in score from baseline to 16 weeks | 
| MMSE (Mini Mental State Examination) |  | Change in score from baseline to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Alzheimer Disease, Exercise, Quality of life, Cardiovascular fitness, Behavioural or psychological symptoms, Physical fitness