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NCT Number: NCT01311492

Exercise Trial for Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Lifestyle Program

Behavioral

The healthy lifestyle program includes upper body stretching and educational workshops. The purpose of this 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. The rational for this "placebo exercise" activity is that it helps foster adherence to this arm of the study and increases the perceived benefit of the healthy lifestyle program to the participants without directly affecting the study outcomes.

physical activity intervention

Behavioral

The physical activity intervention consists of a general weekly physical activity goal of 150 minutes. This is consistent with the public health message from the Surgeon General's report that moderate physical activity should be performed for 30 minutes on most if not all days of the week (150-210 total minutes). This goal is approached in a progressive manner over the course of the trial.

Primary outcomes

  1. Effect of exercise on cognitive decline

    Time frame: 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 outcomes

  1. Measuring the effects of exercise on depression, metabolic indices, and changes in overall function.

    Time frame: 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.

  2. Evidence based feasibility for conducting exercise interventions in the Alzheimer's Disease population.

    Time frame: 6 months

    The third hypothesis is that well controlled exercise interventions can be successfully implemented in subjects with Alzheimer's Disease.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Exercise Trial for Alzheimer's Disease (EXTRA)

Acronym: EXTRA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 9, 2011
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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