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Effect of Physical Exercise in Alzheimer Patients (ADEX)

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Aerobic exercise

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer Disease, Exercise, Cognition, Quality of life, Cardiovascular fitness, Behavioural or psychological symptoms, Physical fitness

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Danish Dementia Research Centre, Department of Neurology, Rigshospitalet.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

16 weeks of aerobic exercise

Usual care.

Outcomes

Primary Outcome Measures

Symbol Digit Modalities Test

Secondary Outcome Measures

NPI (psychological symptoms.)

Astrand submaximal bicycle test for estimating VO2 max

Euro-qol-5D-5L (health related quality of life)

Alzheimer's disease Assessment Scale - Cognitive section (ADAS-cog).

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).

Self-efficacy scale

Verbal fluency

Stroop

MMSE (Mini Mental State Examination)

Full Information

NCT ID

NCT01681602

First Posted

April 30, 2012

Last Updated

November 28, 2014

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT01681602

Brief Title

Effect of Physical Exercise in Alzheimer Patients

Acronym

ADEX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

see protocol article

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

Alzheimer Disease, Exercise, Cognition, Quality of life, Cardiovascular fitness, Behavioural or psychological symptoms, Physical fitness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Active Comparator

Arm Description

16 weeks of aerobic exercise

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Usual care.

Intervention Type

Other

Intervention Name(s)

Aerobic exercise

Other Intervention Name(s)

Endurance training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Symbol Digit Modalities Test

Time Frame