Exercise Trial for Alzheimer's Disease (EXTRA)

Pennington Biomedical Research Center

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Behavioral: Physical Activity Intervention; Behavioral: Healthy Lifestyle Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01311492

PBRC 10035

Details and patient eligibility

About

Exercise Trial for Alzheimer's Disease(EXTRA) is a pilot randomized clinical trial involving a physcial activity program versus a healthy lifestyle program, with one year follow-up in 30 non-disabled, community-dwelling persons, age 65 and older.

Full description

Alzheimer's disease (AD) occurs in 1 in 7 individuals over 65, and 1 in 2 individuals over 85. While the progression of AD is extremely variable, it is generally established that AD subjects will move from having compromised function in socail and work settings, to requiring institutionalization and/or intensive management within 10 years of initial clinical diagnosis. A randomized controlled piot trial is needed to provide information regarding exercies effects on individuals with mild to moderate Alzheimer's disease.

Exercise Trial for Alzheimer's Disease (EXTRA) is a pilot randomized controlled trial designed to compare a moderate-intesity physical activity program to a healthy lifestyle health education program in 30 older adults with mild to moderate Alzheimer's Disease. These individuals will be followed for 1 year.

This trial will provide pilot evidence regarding whether physical activity is effective and practical for individuals with AD. The effects of an exercise intervention on halting, slowing, or reversing the cognitive effects of AD will be assessed with pilot data and potentially provide support for a larger trial in the future.

Enrollment: 10 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 65 years and older
• must be planning to reside in the area for 1 year
• summary scor of greater than or equal to 3 on the Short Physical Performance Battery (SPPB)
• have mild to moderate AD defined by a score of 12-24 on the Mini-Mental Status Examination (MMSE). Diagnosis of probable AD from site physician utilizing the following criteria: Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for Dementia of Alzheimer's Type, National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) Criteria for Probable Alzheimer's Disease, and Hachinski Ischemic Score is less than or equal to 4
• sedentary lifestyle which is operationally defined as spending less than 20 minutes a week in the past month getting regular physical activity.
• must be willing to give informed consent, be willing to be randomized to either physical activity or health lifestyle intervention, and to follow the protocol for the group to which they have been assigned

Exclusion criteria

• unable or unwilling to give informed consent or accept randomization in either study group
• current diagnosis of schizophreniz, other psychotic disorders, or bipolar disorder
• current consumption of more than 14 alcoholic drinks per week
• plans to relocate to out of the study area within the next year or plans to be out of the study area for more than 6 weeks in the next year
• score of greater than 3 on SPPB
• another member of the household is a participant in they study
• residence too far from the intervention site
• difficulty in communication with study personnel due to speech or hearing problems
• MMSE less than 12 or greater than 24
• currently enrolled in another randomized trial involving lifestyle or phamaceutical interventions
• other medical, psychiatric, or behavioral factors that in the judgement of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

Healthy Lifestyle Program

Placebo Comparator group

Description:

The purpose of the healthy lifestyle group is to control for general levels of staff and participant time and attention, in addition to general secular and seasonal effects that could influence the outcomes of interest.

Treatment:

Behavioral: Healthy Lifestyle Program

Physical Activity Intervention

Active Comparator group

Description:

The physical activity program includes aerobic, strenth, flexibility and balance training.

Treatment:

Behavioral: Physical Activity Intervention