Exercise Trial for Alzheimer's Disease

Not Applicable

Completed

• Conditions: Alzheimer's Disease
• Interventions: Behavioral: Physical Activity Intervention; Behavioral: Healthy Lifestyle Program

• Registration Number: NCT01311492
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-09
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Activity Intervention	Physical Activity Intervention	The physical activity program includes aerobic, strenth, flexibility and balance training.
Healthy Lifestyle Program	Healthy Lifestyle Program	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.

Primary Outcome Measures

Name	Time	Method
Effect of exercise on cognitive decline	6 months	The primary hypothesis is that exercise will decrease the congnitive decline in activities of daily living, in the subjects with Alzheimer's Disease.

Secondary Outcome Measures

Name	Time	Method
Evidence based feasibility for conducting exercise interventions in the Alzheimer's Disease population.	6 months	The third hypothesis is that well controlled exercise interventions can be successfully implemented in subjects with Alzheimer's Disease.
Measuring the effects of exercise on depression, metabolic indices, and changes in overall function.	6 months	The secondary hypothesis is that exercise will decrease the level of depression, improve multiple metabolic indices, and improve function in subjects with Alzheimer's Disease.

Trial Locations

Locations (2)

Programs of All-Inclusive Care for the Elderly (PACE); 🇺🇸 Baton Rouge, Louisiana, United States

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States