Effect of Physical Exercise in Alzheimer Patients (ADEX)

November 28, 2014 updated by: Steen G Hasselbalch, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

see protocol article

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen Ø
      • Copenhagen, Copenhagen Ø, Denmark, 2100
        • Danish Dementia Research Centre, Department of Neurology, Rigshospitalet.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Usual care.
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 Names:
  • Endurance training

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NPI (psychological symptoms.)
Time Frame: Change in score from baseline to 16 weeks
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
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
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
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).
Change in score from baseline to 16 weeks
Self-efficacy scale
Time Frame: Change in score from baseline to 16 weeks
Change in score from baseline to 16 weeks
Verbal fluency
Time Frame: Change in score from baseline to 16 weeks
Change in score from baseline to 16 weeks
Stroop
Time Frame: Change in score from baseline to 16 weeks
Change in score from baseline to 16 weeks
MMSE (Mini Mental State Examination)
Time Frame: Change in score from baseline to 16 weeks
Change in score from baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Steen G Hasselbalch, Professor, Memory Disorders Research Group, Department of Neurology, Copenhagen University Hospital, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (Estimate)

September 10, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 28, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2011-128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on Aerobic exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe