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

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.

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: High intensity aerobic exercise+strength; Other: Low intensity aerobic exercise+strength

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GONZALO GRANDES ODRIOZOLA, PHD; Phone Number: 0034946006637; Email: gonzalo.grandesodriozola@osakidetza.net
• Study Contact Backup: Name: MAITE ESPINOSACIFUENTES, MD; Phone Number: 0034946006637; Email: maite.espinosacifuentes@osakidetza.net

Study Locations

• Spain
  • Bilbao
    • Galdakao, Bilbao, Spain
      • Recruiting
      • Galdakao Hospital/Galdakao C.S.
      • Contact: Mª ANGELES GOMEZ BELDARRAIN, PHD; Phone Number: 34 94 400 7234; Email: MARIAANGELES.GOMEZBELDARRAIN@osakidetza.net
      • Contact: JAVIER RUIZ OJEDA, PHD; Phone Number: 34 94 400 7234; Email: JAVIER.RUIZOJEDA@OSAKIDETZA.NET
      • Sub-Investigator: Mª SOLEDAD ARIETALEANIZBEASKOA SARABIA
      • Principal Investigator: ANA DOSIO REVENGA
      • Sub-Investigator: AGUSTÍN SASTRE PEREZ
  • Bizkaia
    • Basauri, Bizkaia, Spain
      • Recruiting
      • Basauri C.S.
      • Contact: NEREA FONCEA BETI, PHD; Phone Number: 03494 4007234; Email: NEREA.FONCEABETI@osakidetza.net
      • Sub-Investigator: VERÓNICA ARCE ARANA
      • Principal Investigator: ANGEL FERNÁNDEZ MARTÍNEZ
      • Sub-Investigator: MARÍA CARBALLUDE PRIETO
      • Sub-Investigator: IZASKUN GAMBOA AURTENECHE
    • Bilbao, Bizkaia, Spain
      • Not yet recruiting
      • Hospital Universitario de Basurto
      • Contact: JUAN Mª UTERGA VALIENTE, PHD; Phone Number: 944006074; Email: JUANMARIA.UTERGAVALIENTE@osakidetza.net
      • Sub-Investigator: MAITE ESPINOSA CIFUENTES, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. 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.	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.
Active Comparator: Low intensity aerobic exercise+strength; The control group performed an exercise program similar to intervention but at low intensity that is below 35 or 40% of heart rate reserve (HRR).	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. --------------------------------------------------------------------------------

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Basque Health Service
• Investigators: Principal Investigator: ANA DOSIO REVENGA, PHD, Osakidetza

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: July 18, 2014
• First Submitted That Met QC Criteria: July 18, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Estimate): July 21, 2014
• Last Update Submitted That Met QC Criteria: July 18, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Alzheimer disease, exercise, cognition
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: 2011111100