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

Alzheimer Disease Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

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

• NCT number: NCT02195596
• Study type: Interventional
• Source: Basque Health Service
• Contact: GONZALO GRANDES ODRIOZOLA, PHD
• Phone: 0034946006637
• Email: gonzalo.grandesodriozola@osakidetza.net
• Status: Recruiting
• Phase: N/A
• Start date: April 2013
• Completion date: December 2015