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Completed

NCT Number: NCT00403507

Exercise Treatment of Mild-Stage Probable Alzheimer's Disease

The purpose of the study is to determine if participation in an exercise program helps memory loss from getting worse, and if it improves daily functioning and attitudes of those with probable Alzheimer's disease. It will involve participation of both the person with memory loss and someone who knows their daily activities (e.g., husband, wife, adult child, or caregiver).

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Key information

About this study

Currently, there is no cure for the memory loss associated with Alzheimer's disease, though some medications can help it from getting worse. The research study will help to answer the question if participation in an exercise program helps memory loss from getting worse, and if it improves daily functioning and attitudes of those with probable Alzheimer's disease. It will involve participation of both the person with memory loss and someone who knows their daily activities.

The research study is a randomized-control trial: some participants will be picked to participate in the exercise program, while others will not. Their memory, thinking abilities, activities, and attitudes will be measured at baseline and follow-up assessment 5-6 months later. Participants are in good health, and are treated with a cholinesterase inhibitor for memory loss (standard treatment).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age is 65 through 89 years old.
  • Completed more than an 8th grade education.
  • Native English speaker.
  • Diagnosis of probable Alzheimer's disease by a primary care physician or specialty clinic.
  • Taking a cholinesterase inhibitor at a therapeutic dose for at least two weeks prior to admission to study (following minimum titration of four weeks), but no other prescribed medication for cognitive functioning (e.g., memantine/Namenda).
  • May have one unstable physical illness that is being treated or a few controlled physical illnesses, is on few medications, and appears no more than mildly ill.
  • Treated stable hypertension & hyperlipidemia are permissible, but resting blood pressure must be <170/100 mm Hg.
  • Normal TSH & Vitamin B12 levels, as confirmed by laboratory data within 3 years.
  • Able to participate a three-day/week physical activity program (No orthopedic, neurologic, or behavioral limitations that may preclude exercise training) for up to 6 months.
  • Patient has a knowledgeable informant who can report the day-to-day activities of participant (e.g., spouse, adult child, paid caregiver).
  • Able to give assent/consent to research study.

Exclusion criteria

  • History of learning or developmental disability.
  • Treatment with hormone replacement therapy during the last year.
  • History of psychiatric condition (including depression).
  • Evidence of serious cardiac condition or significant small vessel disease (e.g., heart bypass surgery, angina, arrhythmia, dyspnea, insulin-dependent diabetes with neuropathy, confluent white matter alterations on structural MRI or CT scan).
  • History of neurologic condition (e.g., large vessel stroke, seizures, Parkinsonism).
  • History of heavy metals exposure.
  • History of sleep disturbance (e.g., treated apnea, insomnia).
  • History of brain injury (including concussion of >10 minutes).
  • History of delirium (change in mental status due to medications) for the past year.
  • No pharmaceutical treatment for mood currently, or history of longstanding depression.

Treatment and study plan

Participation in a monitored exercise program

Behavioral

No contact with control group during 20 weeks.

Personalized aerobic and strength training.

Behavioral

Three-days per week for 20 weeks at hospital gym under supervision of exercise specialist.

Primary outcomes

  1. For the intervention group: Change in cognitive performance relative to baseline

    Time frame: baseline & 20 week follow-up

  2. Group differences in cognitive performance following intervention and relative to wait-list control group

    Time frame: baseline & 20 week follow-up

  3. For the intervention group: Change in attitudes, including self-report of well-being and cognitive abilities relative to baseline

    Time frame: baseline & 20 week follow-up

  4. Group differences in attitudes, including self-report of well-being, following intervention and relative to wait-list control group

    Time frame: baseline & 20 week follow-up

Secondary outcomes

  1. For the intervention group: Change in knowledgeable informant's ratings of function, behavior, and attitudes

    Time frame: baseline & 20 week follow-up

  2. Group differences in knowledgeable informant's ratings of function, behavior, and attitudes following intervention and relative to wait-list control group

    Time frame: baseline & 20 week follow-up

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • Deseret Foundation

Registry information

Official study title

Physical Activity as a Treatment of Mild-Stage Probable Alzheimer's Disease

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 23, 2006
Registry last updated
May 11, 2011

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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