Effects of Exercise on Cognitive Performance of Patients With Alzheimer-type Dementia. Pilot Study.
EFA-P
1 other identifier
interventional
80
1 country
3
Brief Summary
A program that combines high intensity aerobic exercise (\<85% of Heart Rate Reserve) with resistance, progressive and moderate intensity intervals, carried out in primary care, is effective in terms of a smaller increase in respect to the baseline measurement in the total score of the ADAS cognitive section (Alzheimer Disease Assessment Scale-Cognitive section),in the control group that receives an intervention similar to low intensity (30-40% of Heart rate reserve). We Expect a difference of at least 3 points between the means of the increments between the intervention and control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable alzheimer-disease
Started Apr 2013
Typical duration for not_applicable alzheimer-disease
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 18, 2014
CompletedFirst Posted
Study publicly available on registry
July 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 21, 2014
July 1, 2014
1.8 years
July 18, 2014
July 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Cognitive performance is measured in a blinded way with the cognitive section of the ADAS scale (Alzheimer's Disease Assessment Scale) at 0, 6 and 12. ADAS is an instrument designed to assess the severity of cognitive disorders (ADAS-Cog) and noncognitive (ADAS-cog) in patients with Alzheimer-type dementia (ATD). The ADAS-Cog, that we use, consists of 11 items that assess mainly memory (3 items, 27 points), orientation (1 item, 8 points), language (5 items, 25 points) and praxis (2 items, 10 points). The maximum score is 70 points.The higher the score, the greater the cognitive impairment.This is the primary outcome measure most frequently used in clinical trials with drugs.
0, 6 and 12 months
Secondary Outcomes (1)
Global cognitive performance
0, 6 and 12 months
Other Outcomes (1)
neuropsychiatric symptoms and psychopathology
0, 6 and 12 months
Study Arms (2)
High intensity aerobic exercise+strength
EXPERIMENTALThe 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.
Low intensity aerobic exercise+strength
ACTIVE COMPARATORThe control group performed an exercise program similar to intervention but at low intensity that is below 35 or 40% of heart rate reserve (HRR).
Interventions
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 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. \--------------------------------------------------------------------------------
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Galdakao Hospital/Galdakao C.S.
Galdakao, Bilbao, Spain
Basauri C.S.
Basauri, Bizkaia, Spain
Hospital Universitario de Basurto
Bilbao, Bizkaia, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ANA DOSIO REVENGA, PHD
Osakidetza
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Family physician
Study Record Dates
First Submitted
July 18, 2014
First Posted
July 21, 2014
Study Start
April 1, 2013
Primary Completion
January 1, 2015
Study Completion
December 1, 2015
Last Updated
July 21, 2014
Record last verified: 2014-07