Physical Exercise as an Additional Treatment for Alzheimer Disease

NCT01515982 | Completed DMC

• 1 other identifier: 60liv02-09B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The state of the art with regard to the neurodegenerative dementias, especially for Alzheimer´s disease (AD), is that their progression is still irreversible causing cognitive, motor, and behavioral impairment. Although the current pharmacological treatments attenuate cognitive decline in some cases, the majority of treatments does not avoid the motor and functional changes caused by the progress of the disease. Although several studies show that exercise has a positive effect when it comes to the treatment of the disease, some methodological questions affect the application of the training protocols. The use of recognized intensity patterns like maximum oxygen uptake (VO2max) and maximum heart rate (HRmax) percentage to control the training of patients with dementia is still rare in the literature. Therefore, this seems to interfere on the definition of an ideal prescription. Following this line of reasoning, the purpose of the present study is to assess the effect of moderate aerobic exercise on cognition and functional abilities in AD patients. Design: Randomized controlled trial, double-blinded, with 16-week follow-up. Setting: Center for Alzheimer's disease in the Institute of Psychiatry of the Federal University of Rio de Janeiro. Participants: Elderly with Alzheimer disease. Interventions: The patients will be randomly assigned to an exercise group (EG) on a treadmill (30 minutes, twice a week and moderate intensity of 60% VO2max) and a control group (CG). Main outcome measures: Cognitive function will be assessed using CAMCOG, Trail Making Test A, Digit Span, Stroop Test, Rey auditory-verbal learning test and Clock Test, and functional capacity will be evaluated using Berg Balance Scale (BERG), Sit-to-Stand test (STS), functional reach test (FR), and the time to up and go test (TUGT).

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease; Aerobic exercise; Physical training; Cognitive function; Functional capacity.

Outcome Measures

Primary Outcomes (1)

• Change from baseline in CAMCOG scale at 16 weeks

  The general cognitive state will be assessed by the Brazilian validated version of the CAMCOG, which is part of the cognitive evaluation developed by the CAMDEX (Cambridge Examination for Mental Disorders of the Elderly) and is subdivided in scales which assess orientation, expressive and comprehensive language, memory (including remote memory, recent memory and learning processes), attention, praxis, calculation, abstract thinking and perception.

  from date to randomization at 16 weeks

Secondary Outcomes (4)

• Change from baseline in Time to Up and Go Test at 16 weeks

  from date to randomization at 16 weeks

• Change from baseline in Sit-to-Stand test at 16 weeks

  from date to randomization at 16 weeks

• Change from baseline in Berg Balance Scale at 16 weeks

  from date to randomization at 16 weeks

• Change from baseline in Trail Making Test at 16 weeks

  from date to randomization at 16 weeks

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

The training exercise intensity is established at 60% of VO2máx. Each aerobic session began with a 10-minute warm-up period (40%VO2máx), followed by 20 minutes of continuous treadmill walking at an intensity established by 60% of VO2máx. The exercise session will be concluded with a 5 minutes of cool down. Heart hate (Polar® Sport Tester, Finland) and perceived exertion (Borg Scale) will be monitored and recorded at each five minutes during each exercise session by physical education instructors.

Behavioral: Aerobic Exercise; Behavioral: Control Group

Control group

NO INTERVENTION

All participants were asked not to commence any new exercise regimen.

Interventions

Aerobic Exercise BEHAVIORAL

The training exercise intensity is established at 60% of VO2máx. This intensity was determined using exercise prescription guidelines established by the American College of Sports Medicine (ACSM). Each aerobic session began with a 10-minute warm-up period (40%VO2máx), followed by 20 minutes of continuous treadmill walking at an intensity established by 60% of VO2máx. The exercise session will be concluded with a 5 minutes of cool down. Heart hate (Polar® Sport Tester, Finland) and perceived exertion (Borg Scale) will be monitored and recorded at each five minutes during each exercise session by physical education instructors.

Aerobic exercise

Control Group BEHAVIORAL

All participants were asked not to commence any new exercise regimen.

Aerobic exercise

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke- Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and National Institute of Neurological Disorders and Stroke- Association Internationale pour la Recherche et l' Enseignement en Neurosciences (NINDS-AIREN),respectively
• Mini-Mental State Examination (MMSE) score ≥ 15
• Clinical Dementia Rating (CDR) score 1
• Regular use of anticholinesterase drugs for at least six months
• Cardiologist's authorization
• At least six months without practicing physical exercises.

You may not qualify if:

• Clinical depression or Cornell Scale ≥ 7
• Other types of dementia
• Physical limitation due to other pathologies or associated neurological disease
• Severe or uncontrolled arterial hypertension
• Marked visual and/or auditory deficit
• Incapacity to perform physical exercise due to neurological or neuromuscular impairments
• Illiteracy
• Less than six months of treatment at the outpatient unit.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Exercise; Control Groups

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 24, 2012
• Study Start: February 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

BR (1)