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Effect of Physical Exercise in Alzheimer Patients (ADEX)

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ClinicalTrials.gov Identifier: NCT01681602
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):
Steen G Hasselbalch, Rigshospitalet, Denmark

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: Aerobic exercise Phase 3

Detailed Description:
see protocol article

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preserving Quality of Life, Physical Health and Functional Ability in Alzheimer's Disease: The Effect of Physical Exercise
Study Start Date : January 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Active Comparator: Intervention group
16 weeks of aerobic exercise
Other: Aerobic exercise
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.
Other Name: Endurance training

No Intervention: Control group
Usual care.

Primary Outcome Measures :
  1. Symbol Digit Modalities Test [ Time Frame: Change in score from baseline to 16 weeks ]

Secondary Outcome Measures :
  1. NPI (psychological symptoms.) [ Time Frame: Change in score from baseline to 16 weeks ]
  2. Astrand submaximal bicycle test for estimating VO2 max [ Time Frame: Change in score from baseline to 16 weeks ]
  3. Euro-qol-5D-5L (health related quality of life) [ Time Frame: Change in score from baseline to 16 weeks ]
  4. Alzheimer's disease Assessment Scale - Cognitive section (ADAS-cog). [ Time Frame: Change in score from baseline to 16 weeks ]
  5. Changes in physical fitness [ Time Frame: Change in score from baseline to 16 weeks ]
    Timed up and go test (TUG), 10 m walk, 10m Dual-Task, 400m fast walking, Sit-to-stand (number in 30 sec.)(STS).

  6. Self-efficacy scale [ Time Frame: Change in score from baseline to 16 weeks ]
  7. Verbal fluency [ Time Frame: Change in score from baseline to 16 weeks ]
  8. Stroop [ Time Frame: Change in score from baseline to 16 weeks ]
  9. MMSE (Mini Mental State Examination) [ Time Frame: Change in score from baseline to 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01681602

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Danish Dementia Research Centre, Department of Neurology, Rigshospitalet.
Copenhagen, Copenhagen Ø, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Steen G Hasselbalch, Professor Memory Disorders Research Group, Department of Neurology, Copenhagen University Hospital, Rigshospitalet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Steen G Hasselbalch, Associate Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01681602    
Other Study ID Numbers: H-3-2011-128
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Keywords provided by Steen G Hasselbalch, Rigshospitalet, Denmark:
Alzheimer Disease
Quality of life
Cardiovascular fitness
Behavioural or psychological symptoms
Physical fitness
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders