Effect of Physical Exercise in Alzheimer Patients (ADEX)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Steen G Hasselbalch, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01681602
First received: April 30, 2012
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Alzheimer Disease
Other: Aerobic exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Symbol Digit Modalities Test [ Time Frame: Change in score from baseline to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NPI (psychological symptoms.) [ Time Frame: Change in score from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Astrand submaximal bicycle test for estimating VO2 max [ Time Frame: Change in score from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Euro-qol-5D-5L (health related quality of life) [ Time Frame: Change in score from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Alzheimer's disease Assessment Scale - Cognitive section (ADAS-cog). [ Time Frame: Change in score from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Changes in physical fitness [ Time Frame: Change in score from baseline to 16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Verbal fluency [ Time Frame: Change in score from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Stroop [ Time Frame: Change in score from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • MMSE (Mini Mental State Examination) [ Time Frame: Change in score from baseline to 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681602

Contacts
Contact: Kristine Hoffmann, MD +45 35457662 kristine.hoffmann@rh.regionh.dk

Locations
Denmark
Danish Dementia Research Centre, Department of Neurology, Rigshospitalet. Recruiting
Copenhagen, Copenhagen Ø, Denmark, 2100
Contact: Jette Rasmussen    +45 35453572    jette.rasmussen@rh.regionh.dk   
Principal Investigator: Birgitte Bo Andersen, DMSc, M.D         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Steen G Hasselbalch, Associate Professor Memory Disorders Research Group, Department of Neurology, Copenhagen University Hospital, Rigshospitalet
  More Information

No publications provided

Responsible Party: Steen G Hasselbalch, Associate Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01681602     History of Changes
Other Study ID Numbers: H-3-2011-128
Study First Received: April 30, 2012
Last Updated: September 5, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Health and Medicines Authority

Keywords provided by Rigshospitalet, Denmark:
Alzheimer Disease
Exercise
Cognition
Quality of life
Cardiovascular fitness
Behavioural or psychological symptoms
Physical fitness

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014