Effects of Exercise on Cognitive Performance of Patients With Alzheimer-type Dementia. Pilot Study.

Alzheimer Disease Clinical Trial

— EFA-P  

Official title:

Effects of Exercise on Cognitive Performance of Patients With Alzheimer-type Dementia. Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02195596
• Other study ID #: 2011111100
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2014
• Last updated: July 18, 2014
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2014
• Source: Basque Health Service
• Contact: GONZALO GRANDES ODRIOZOLA, PHD
• Phone: 0034946006637
• Email: gonzalo.grandesodriozola[@]osakidetza.net
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVE: To evaluate an intervention that combines high intensity aerobic exercise with strength (AAAD) on general cognitive performance of patients affected by mild Alzheimer's disease (AD). DESIGN: Randomized clinical trial in two parallel groups: SCOPE: 2 health center of Basque Health Service , in coordination with its reference neurology services. PARTICIPANTS: 80 patients with mild AD.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria: Subjects aged between 55 and 85 who meet, at the time of entry into the study, clinical criteria compatible with probable AD according to the criteria of the National Institute on Aging and the Alzheimer's Association, under mild or DCL-Alzheimers (Folstein MMSE> 19/20, GDS 3-4), diagnosis will be performed by specialist neurologists according to standard practice. Patients should be able to perform physical activity on a cycle ergometer or treadmill and also must exist a caregiver who agrees to accompany him to the physical exercise sessions.

Exclusion Criteria: Central nervous system disease history with the possibility of neuropsychological impairment (stroke, epilepsy, meningitis, severe head trauma). History of alcohol and drug abuse. Hachinski Ischemic Scale = 7. Major depression diagnosed(CIE-10). History of severe psychiatric disease. Predictable changes in medication that may affect cognitive performance. Visual or auditory perceptual disorders that limit neuropsychological assessment. Unstable heart disease, severe behavioral problems that make impossible the intervention, or any condition judged by the investigator that advises against the intervention. -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Basauri C.S.	Basauri	Bizkaia
Spain	Hospital Universitario de Basurto	Bilbao	Bizkaia
Spain	Galdakao Hospital/Galdakao C.S.	Galdakao	Bilbao

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	neuropsychiatric symptoms and psychopathology	NPI will be employed to asses treatment related behavioral changes and the presence of psychopathology in patients receiving exercise	0, 6 and 12 months	Yes
Primary	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	Yes
Secondary	Global cognitive performance	Global cognitive performance is measured with Test Barcelona TBR-B neuropsychological battery (abreviated version).The ADAS-COG wich is focused on the most devastated areas by Alzheimer's disease, will be complemented by the TBA-B, which has been developed in our environment, makes possible a more global assessment, and also presents adequate psychometric properties.	0, 6 and 12 months	Yes