- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01515982
Physical Exercise as an Additional Treatment for Alzheimer Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Design: Four-month controlled, randomized, and double-blind study. The patients will be recruited by trained psychiatrists from the Center for Alzheimer's disease in the Institute of Psychiatry of the Federal University of Rio de Janeiro (IPUB/UFRJ). They will be randomized with a blind design to an exercise group (EG) and control group (CG) by a researcher who will not participate of the initial assessments.
- Intervention
On completion of the baseline assessment, all patients will be invited to engage in the exercise program. Those who accept to take part and will be available, having easy access to the facilities, will be included in the sample. The other ones will be included in the control group. So, subjects will be divided by two groups: medical care (control) and medical care + physical exercise.
- Medical care control group (C): Subjects will maintain clinical treatment.
- Medical care + exercise group (E): This group will be prescribed the exercise treatment as an adjunctive intervention to drug therapy. Patients who accept to participate in this group will be evaluated with a thorough clinical exam and with a resting electrocardiogram. The training exercise intensity is established at 60% of VO2máx. This intensity was determined using exercise prescription guidelines established by the American College of Sports Medicine (ACSM). Each aerobic session began with a 10-minute warm-up period (40%VO2máx), followed by 20 minutes of continuous treadmill walking at an intensity established by 60% of VO2máx, according to ACMS guidelines (2006). The exercise session will be concluded with a five minutes of cool down. Heart hate (Polar® Sport Tester, Finland) and perceived exertion (Borg Scale) will be monitored and recorded at each five minutes during each exercise session by physical education instructors. Subjects will be encouraged to attend two supervised exercise sessions per week for 16 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Rio de Janeiro, Brazil
- Universidade Federal do Rio de Janeiro
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke- Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and National Institute of Neurological Disorders and Stroke- Association Internationale pour la Recherche et l' Enseignement en Neurosciences (NINDS-AIREN),respectively
- Mini-Mental State Examination (MMSE) score ≥ 15
- Clinical Dementia Rating (CDR) score 1
- Regular use of anticholinesterase drugs for at least six months
- Cardiologist's authorization
- At least six months without practicing physical exercises.
Exclusion Criteria:
- Clinical depression or Cornell Scale ≥ 7
- Other types of dementia
- Physical limitation due to other pathologies or associated neurological disease
- Severe or uncontrolled arterial hypertension
- Marked visual and/or auditory deficit
- Incapacity to perform physical exercise due to neurological or neuromuscular impairments
- Illiteracy
- Less than six months of treatment at the outpatient unit.
Study Plan
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 |
---|---|
Experimental: Aerobic exercise
The training exercise intensity is established at 60% of VO2máx.
Each aerobic session began with a 10-minute warm-up period (40%VO2máx), followed by 20 minutes of continuous treadmill walking at an intensity established by 60% of VO2máx.
The exercise session will be concluded with a 5 minutes of cool down.
Heart hate (Polar® Sport Tester, Finland) and perceived exertion (Borg Scale) will be monitored and recorded at each five minutes during each exercise session by physical education instructors.
|
The training exercise intensity is established at 60% of VO2máx.
This intensity was determined using exercise prescription guidelines established by the American College of Sports Medicine (ACSM).
Each aerobic session began with a 10-minute warm-up period (40%VO2máx), followed by 20 minutes of continuous treadmill walking at an intensity established by 60% of VO2máx.
The exercise session will be concluded with a 5 minutes of cool down.
Heart hate (Polar® Sport Tester, Finland) and perceived exertion (Borg Scale) will be monitored and recorded at each five minutes during each exercise session by physical education instructors.
All participants were asked not to commence any new exercise regimen.
|
No Intervention: Control group
All participants were asked not to commence any new exercise regimen.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in CAMCOG scale at 16 weeks
Time Frame: from date to randomization at 16 weeks
|
The general cognitive state will be assessed by the Brazilian validated version of the CAMCOG, which is part of the cognitive evaluation developed by the CAMDEX (Cambridge Examination for Mental Disorders of the Elderly) and is subdivided in scales which assess orientation, expressive and comprehensive language, memory (including remote memory, recent memory and learning processes), attention, praxis, calculation, abstract thinking and perception.
|
from date to randomization at 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Time to Up and Go Test at 16 weeks
Time Frame: from date to randomization at 16 weeks
|
The "Timed Up and Go" test (TUGT) and its modified version "Modified Timed up and go" (TUG mod) have been used with the objective of evaluating the functional mobility and the double task, respectively.
In the first test, the patient walks three meters while the time is counted, and, in the second one, the patient is asked to walk and evoke names of animals.
More than 10 seconds is considered risk of functional loss.
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from date to randomization at 16 weeks
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Change from baseline in Sit-to-Stand test at 16 weeks
Time Frame: from date to randomization at 16 weeks
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The Sit-to-Stand test (STS) counts the number of times the patient can sit down and stand up in 30 seconds.
This test evaluates lower limb strength and it is associated to the cardiovascular capacity of elderly people.
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from date to randomization at 16 weeks
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Change from baseline in Berg Balance Scale at 16 weeks
Time Frame: from date to randomization at 16 weeks
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Berg Balance Scale (BERG) is composed by 14 tasks related to daily life and each item has one ordinal scale of five alternatives which vary from 0 to 4 points, with a total of 56 points.
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from date to randomization at 16 weeks
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Change from baseline in Trail Making Test at 16 weeks
Time Frame: from date to randomization at 16 weeks
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Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper.
In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order.
In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters.
The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper.
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from date to randomization at 16 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60liv02-09B
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.
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