NCT02195596

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Basque Health Service · Other Government
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
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.
OTHER	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. \--------------------------------------------------------------------------------

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-01-01
• Completion: 2015-12-01
• First posted: 2014-07-21
• Last updated: 2014-07-21

Locations

3 sites across 1 country: Spain