Exercise Trial for Alzheimer's Disease (EXTRA)

This study has been completed.
Sponsor:
Collaborator:
St. James Place of Baton Rouge
Information provided by (Responsible Party):
Timothy Church, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01311492
First received: March 7, 2011
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Alzheimer's Disease
Behavioral: Healthy Lifestyle Program
Behavioral: Physical Activity Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Exercise Trial for Alzheimer's Disease (EXTRA)

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Effect of exercise on cognitive decline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Measuring the effects of exercise on depression, metabolic indices, and changes in overall function. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Evidence based feasibility for conducting exercise interventions in the Alzheimer's Disease population. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The third hypothesis is that well controlled exercise interventions can be successfully implemented in subjects with Alzheimer's Disease.


Enrollment: 10
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
Behavioral: Healthy Lifestyle Program
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.
Active Comparator: Physical Activity Intervention
The physical activity program includes aerobic, strenth, flexibility and balance training.
Behavioral: Physical Activity Intervention
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311492

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Programs of All-Inclusive Care for the Elderly (PACE)
Baton Rouge, Louisiana, United States, 70806
Sponsors and Collaborators
Pennington Biomedical Research Center
St. James Place of Baton Rouge
Investigators
Principal Investigator: Timothy S. Church, MD, MPH, PhD Pennington Biomedical Research Center
Principal Investigator: Jeffrey N. Keller, PhD Pennington Biomedical Research Center
Study Director: Robert M. Brouilette, MS Pennington Biomedical Research Center
Study Director: Valerie H. Myers, PhD Pennington Biomedical Research Center
Study Director: Susan Nelson, MD Programs of All-Inclusive Care for the Elderly (P.A.C.E.)
  More Information

Publications:

Responsible Party: Timothy Church, Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01311492     History of Changes
Other Study ID Numbers: PBRC10035
Study First Received: March 7, 2011
Last Updated: May 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Pennington Biomedical Research Center:
Alzheimer's Disease
exercise
physical activity
intervention

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014