Effects of Exercise on Cognitive Performance of Patients With Alzheimer-type Dementia. Pilot Study.
NCT ID: NCT02195596
Last Updated: 2014-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2013-04-30
2015-12-31
Brief Summary
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We Expect a difference of at least 3 points between the means of the increments between the intervention and control group.
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Detailed Description
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INTERVENTION: Both groups receiving standard drug treatment. The intervention group also receive a supervised EEAA program, while the control group receive a similar intervention at low intensity. Patients are followed up over 1 year. Three blind measurements are made repeatedly : baseline, at 6 and 12 months. MEASUREMENTS: The primary outcome measure is change in cognitive performance that is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12.Secondary Outcomes: Global cognitive performance (Neuropsychological battery TBR-B),neuropsychiatric symptoms (NPI), ADL (Blessed),functional capacity (Test of 6-minute walk), cardiorespiratory Test, muscular strength (hand dynamometer and trunk); PREDICTORS AND CONFOUNDING VARIABLES: baseline cognitive performance, previous physical activity, medication, age, sex, APOE, schooling and cognitive reserve. ANALYSIS: We compared the two groups in terms of observed mean changes from baseline in ADAS measurement and other variables, intention to treat, using longitudinal mixed effects models for repeated measures at 6 and 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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High intensity aerobic exercise+strength
The program consist in a "Continuous High aerobic exercise and moderate intensity intervals" (ShoshanaB et al, 2012) combined with "muscular strength exercises and joint mobility". Patients come three times a week for six months to the primary health center. A fitness expert nurse is responsible for monitoring the performance and adapt to the physical condition of the patient.Each exercise session consists of warming up time period, period of work and back to calm. Exercise intensity during the work period increases progressively as the program progresses. Aerobic exercise is performed on a cycle ergometer or treadmill.Muscle strength exercises and joint mobility are performed with dumbbells and ankle weights adapted to each patient.
High intensity aerobic exercise+strength
The program consist in a "Continuous High aerobic exercise and moderate intensity intervals" (ShoshanaB et al, 2012) combined with "muscular strength exercises and joint mobility". Patients come three times a week for six months to the primary health center and will be supervised by an expert nurse.
Low intensity aerobic exercise+strength
The control group performed an exercise program similar to intervention but at low intensity that is below 35 or 40% of heart rate reserve (HRR).
Low intensity aerobic exercise+strength
Low intensity aerobic exercise+strength program is similar to the other intervention but differs in the intensity of the exercise as it works with intensities below 40% of heart rate reserve.
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Interventions
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High intensity aerobic exercise+strength
The program consist in a "Continuous High aerobic exercise and moderate intensity intervals" (ShoshanaB et al, 2012) combined with "muscular strength exercises and joint mobility". Patients come three times a week for six months to the primary health center and will be supervised by an expert nurse.
Low intensity aerobic exercise+strength
Low intensity aerobic exercise+strength program is similar to the other intervention but differs in the intensity of the exercise as it works with intensities below 40% of heart rate reserve.
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Eligibility Criteria
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Inclusion Criteria
55 Years
85 Years
ALL
No
Sponsors
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Basque Health Service
OTHER_GOV
Responsible Party
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Ana Dosío Revenga
Family physician
Principal Investigators
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ANA DOSIO REVENGA, PHD
Role: PRINCIPAL_INVESTIGATOR
Osakidetza
Locations
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Galdakao Hospital/Galdakao C.S.
Galdakao, Bilbao, Spain
Basauri C.S.
Basauri, Bizkaia, Spain
Hospital Universitario de Basurto
Bilbao, Bizkaia, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2011111100
Identifier Type: -
Identifier Source: org_study_id
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