Effect of Physical Exercise in Alzheimer Patients (ADEX)
|ClinicalTrials.gov Identifier: NCT01681602|
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : December 2, 2014
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Primary Completion Date :||January 2014|
|Study Completion Date :||June 2014|
U.S. FDA Resources
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
- Symbol Digit Modalities Test [ Time Frame: Change in score from baseline to 16 weeks ]
- NPI (psychological symptoms.) [ Time Frame: Change in score from baseline to 16 weeks ]
- Astrand submaximal bicycle test for estimating VO2 max [ Time Frame: Change in score from baseline to 16 weeks ]
- Euro-qol-5D-5L (health related quality of life) [ Time Frame: Change in score from baseline to 16 weeks ]
- Alzheimer's disease Assessment Scale - Cognitive section (ADAS-cog). [ Time Frame: Change in score from baseline to 16 weeks ]
- 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).
- Self-efficacy scale [ Time Frame: Change in score from baseline to 16 weeks ]
- Verbal fluency [ Time Frame: Change in score from baseline to 16 weeks ]
- Stroop [ Time Frame: Change in score from baseline to 16 weeks ]
- MMSE (Mini Mental State Examination) [ Time Frame: Change in score from baseline to 16 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681602
|Danish Dementia Research Centre, Department of Neurology, Rigshospitalet.|
|Copenhagen, Copenhagen Ø, Denmark, 2100|
|Principal Investigator:||Steen G Hasselbalch, Professor||Memory Disorders Research Group, Department of Neurology, Copenhagen University Hospital, Rigshospitalet|