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Exercise Trial for Alzheimer's Disease (EXTRA)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Lifestyle Program
Physical Activity Intervention
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, exercise, physical activity, intervention

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Programs of All-Inclusive Care for the Elderly (PACE)
  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Healthy Lifestyle Program

Physical Activity Intervention

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
March 7, 2011
Last Updated
September 13, 2022
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01311492
Brief Title
Exercise Trial for Alzheimer's Disease
Acronym
EXTRA
Official Title
Exercise Trial for Alzheimer's Disease (EXTRA)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease, exercise, physical activity, intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Lifestyle Program
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Physical Activity Intervention
Arm Type
Active Comparator
Arm Description
The physical activity program includes aerobic, strenth, flexibility and balance training.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Lifestyle Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Intervention
Intervention Description
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 Outcome Measure Information:
Title
Effect of exercise on cognitive decline
Description
The primary hypothesis is that exercise will decrease the congnitive decline in activities of daily living, in the subjects with Alzheimer's Disease.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Measuring the effects of exercise on depression, metabolic indices, and changes in overall function.
Description
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.
Time Frame
6 months
Title
Evidence based feasibility for conducting exercise interventions in the Alzheimer's Disease population.
Description
The third hypothesis is that well controlled exercise interventions can be successfully implemented in subjects with Alzheimer's Disease.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy S. Church, MD, MPH, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey N. Keller, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert M. Brouilette, MS
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Valerie H. Myers, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Susan Nelson, MD
Organizational Affiliation
Programs of All-Inclusive Care for the Elderly (P.A.C.E.)
Official's Role
Study Director
Facility Information:
Facility Name
Programs of All-Inclusive Care for the Elderly (PACE)
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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Exercise Trial for Alzheimer's Disease

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