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Pilot Study of Aerobic Exercise in Early Alzheimer's Disease(AD)

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aerobic Exercise

Stretching

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Informed consent provided by the participant or the participant's legally acceptable representative
Age 55 years or older
Diagnosis of Probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
Clinical Dementia Rating (CDR) of 0.5 (very mild) or 1 (mild dementia)
Mini-Mental Status Exam Score of 16 to 30, inclusive.
Rosen Modified Hachinski score of 4 or less
Community dwelling with a caregiver able and willing to accompany the participant on all visits, if necessary. The caregiver must visit with the subject more than five times a week for the duration of the study.
Underactive or sedentary as determined by a Telephone Assessment of Physical Activity.
Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments
Stable doses of medications for at least 30 days prior to screening. Cholinesterase inhibitors and memantine are allowed provided the participant is on stable doses without clinically significant side effects for 60 days. Additionally, the participant and caregiver will agree, barring unforeseen circumstances, to continue the same regimen for the trial duration.
Likely to participate in all scheduled evaluations and complete the 26 week program.

Exclusion Criteria:

CDR 0.5 uncertain dementia (i.e., not meeting NINCDS-ADRDA criteria).
Significant neurological disease, other than AD, that may affect cognition
MRI or CT scan indicative of significant abnormalities that may explain cognitive decline (e.g., multiple lacunar infarcts or a single prior infarct > 1 cm3, micro-hemorrhages or evidence of a prior hemorrhage > 1 cm3, evidence of cerebral contusion, encephalomalacia, aneurysm, vascular malformation, or space-occupying lesion such as an arachnoid cyst or brain tumor)
Current clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to DSM-IV criteria or significant psychiatric symptoms (e.g., hallucinations) that could impair the completion of the study. Individuals with depressive symptoms (Geriatric Depression Scale < 6) and who do not meet criteria for major depression will be eligible.
Current clinically-significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study
History of clinically-evident stroke
Clinically-significant infection within the last 30 days
Myocardial infarction or symptoms of coronary artery disease (e.g., angina) in the last two-years.
Uncontrolled hypertension within the last 6 months
History of cancer within the last 5 years (except non-metastatic basal or squamous cell carcinoma)
History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
Presence of contraindications for MRI scanning (pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects) or claustrophobia
Insulin-dependent diabetes mellitus
Significant pain or musculoskeletal disorder that would prohibit participation in an exercise program

Sites / Locations

University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic Exercise

Stretching

Arm Description

Outcomes

Primary Outcome Measures

Memory Composite

A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset of individuals without dementia. Then the 4 standardized scores were averaged. Numbers closer to positive indicate better memory performance. The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores.

Executive Function Composite

A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset. Then the 4 standardized scores were averaged. Numbers closer to positive indicate better executive function performance. . The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores.

Disability Assessment for Dementia

This is a validated measure of disability for individuals with dementia. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability.

Cornell Scale for Depression in Dementia

The Cornell Scale for Depression in Dementia is a validate measure of depressive symptoms in individuals with dementia. Larger numbers indicate greater levels of depression. Scores range from 0 to 38.

Secondary Outcome Measures

Full Information

NCT ID

NCT01128361

First Posted

May 18, 2010

Last Updated

January 22, 2017

Sponsor

Jeff Burns, MD

1. Study Identification

Unique Protocol Identification Number

NCT01128361

Brief Title

Pilot Study of Aerobic Exercise in Early Alzheimer's Disease(AD)

Official Title

Alzheimer's Disease Exercise Prevention Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jeff Burns, MD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The current project is a natural extension of a programmatic line of investigation into the relationship between exercise, brain aging, and AD that Dr. Burns has developed over the last four years. The current study will provide data to estimate expected effect sizes for power analyses and sample size calculations. It will also provide an opportunity to optimally design a larger trial that can be extended to multiple sites to more definitively examine the role of exercise as a therapy in AD. The current project's aims are an important and necessary developmental step given the lack of fitness data in AD and the limited knowledge of the mechanisms that may form the basis of an association between aerobic fitness and AD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aerobic Exercise

Arm Type

Experimental

Arm Title

Stretching

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Aerobic Exercise

Intervention Description

Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.

Intervention Type

Behavioral

Intervention Name(s)

Stretching

Intervention Description

This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.

Primary Outcome Measure Information:

Title

Memory Composite

Description

Time Frame

week 0, 13, and 26

Title

Executive Function Composite

Description

A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset. Then the 4 standardized scores were averaged. Numbers closer to positive indicate better executive function performance. . The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores.

Time Frame

Week 0, 13, and 26

Title

Disability Assessment for Dementia

Description

This is a validated measure of disability for individuals with dementia. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability.

Time Frame

Week 0, 13, and 26

Title

Cornell Scale for Depression in Dementia

Description

Time Frame

Week 0, 13, and 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent provided by the participant or the participant's legally acceptable representative Age 55 years or older Diagnosis of Probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Clinical Dementia Rating (CDR) of 0.5 (very mild) or 1 (mild dementia) Mini-Mental Status Exam Score of 16 to 30, inclusive. Rosen Modified Hachinski score of 4 or less Community dwelling with a caregiver able and willing to accompany the participant on all visits, if necessary. The caregiver must visit with the subject more than five times a week for the duration of the study. Underactive or sedentary as determined by a Telephone Assessment of Physical Activity. Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments Stable doses of medications for at least 30 days prior to screening. Cholinesterase inhibitors and memantine are allowed provided the participant is on stable doses without clinically significant side effects for 60 days. Additionally, the participant and caregiver will agree, barring unforeseen circumstances, to continue the same regimen for the trial duration. Likely to participate in all scheduled evaluations and complete the 26 week program. Exclusion Criteria: CDR 0.5 uncertain dementia (i.e., not meeting NINCDS-ADRDA criteria). Significant neurological disease, other than AD, that may affect cognition MRI or CT scan indicative of significant abnormalities that may explain cognitive decline (e.g., multiple lacunar infarcts or a single prior infarct > 1 cm3, micro-hemorrhages or evidence of a prior hemorrhage > 1 cm3, evidence of cerebral contusion, encephalomalacia, aneurysm, vascular malformation, or space-occupying lesion such as an arachnoid cyst or brain tumor) Current clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to DSM-IV criteria or significant psychiatric symptoms (e.g., hallucinations) that could impair the completion of the study. Individuals with depressive symptoms (Geriatric Depression Scale < 6) and who do not meet criteria for major depression will be eligible. Current clinically-significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study History of clinically-evident stroke Clinically-significant infection within the last 30 days Myocardial infarction or symptoms of coronary artery disease (e.g., angina) in the last two-years. Uncontrolled hypertension within the last 6 months History of cancer within the last 5 years (except non-metastatic basal or squamous cell carcinoma) History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years Presence of contraindications for MRI scanning (pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects) or claustrophobia Insulin-dependent diabetes mellitus Significant pain or musculoskeletal disorder that would prohibit participation in an exercise program

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Burns, MD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28187125

Citation

Morris JK, Vidoni ED, Johnson DK, Van Sciver A, Mahnken JD, Honea RA, Wilkins HM, Brooks WM, Billinger SA, Swerdlow RH, Burns JM. Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial. PLoS One. 2017 Feb 10;12(2):e0170547. doi: 10.1371/journal.pone.0170547. eCollection 2017.

Results Reference

derived

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Pilot Study of Aerobic Exercise in Early Alzheimer's Disease(AD)

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