Ignite Creation Date:
2024-05-06 @ 3:03 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02195596
Status:
UNKNOWN
Last Update Posted:
2014-07-21
First Post:
2014-07-18
Brief Title:
Effects of Exercise on Cognitive Performance of Patients With Alzheimer-type Dementia Pilot Study
Sponsor:
Basque Health Service
Organization:
Basque Health Service
Study Overview
Official Title:
Effects of Exercise on Cognitive Performance of Patients With Alzheimer-type Dementia Pilot Study
Status:
UNKNOWN
Status Verified Date:
2014-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFA-P
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 sectionin 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
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 Alzheimers 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 Alzheimers Disease Assessment Scale at 0 6 and 12Secondary Outcomes Global cognitive performance Neuropsychological battery TBR-Bneuropsychiatric symptoms NPI ADL Blessedfunctional 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
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 Alzheimers Disease Assessment Scale at 0 6 and 12Secondary Outcomes Global cognitive performance Neuropsychological battery TBR-Bneuropsychiatric symptoms NPI ADL Blessedfunctional 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None