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Exercise in Adults With Mild Memory Problems (EXERT)

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ClinicalTrials.gov Identifier: NCT02814526
Recruitment Status : Active, not recruiting
First Posted : June 27, 2016
Last Update Posted : September 14, 2021
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Wake Forest University
Information provided by (Responsible Party):
Alzheimer's Disease Cooperative Study (ADCS)

Tracking Information
First Submitted Date  ICMJE June 2, 2016
First Posted Date  ICMJE June 27, 2016
Last Update Posted Date September 14, 2021
Actual Study Start Date  ICMJE September 13, 2016
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
Cognitive function composite score (ADAS-Cog-Exec) [ Time Frame: 12 months ]
The ADAS-Cog is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. The 13-item version of the ADAS-Cog will be administered in EXERT, which includes Delayed Word Recall and Number Cancellation. Scores can range from 0 (best) to 80 (worse).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
  • Clinical Dementia Rating Scale - Sum of Boxes (CDR) [ Time Frame: 12 months ]
  • Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI) [ Time Frame: 12 months ]
    Magnetic Resonance Imaging (MRI) will be used to assess the effect of treatment on rate of whole brain volume
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise in Adults With Mild Memory Problems
Official Title  ICMJE Therapeutic Effects of Exercise in Adults With Amnestic Mild Cognitive Impairment
Brief Summary

This study evaluates the effects of physical exercise on cognition, functional status, brain atrophy and blood flow, and cerebrospinal fluid biomarkers of Alzheimer's disease in adults with a mild memory impairment.

Half of participants will participate in a stretching-balance-range of motion exercise program, while the other half will participate in a moderate/high aerobic training program.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mild Cognitive Impairment
  • Cognitive Decline
  • Memory Impairment
Intervention  ICMJE
  • Behavioral: Aerobic exercise
    Moderate/high intensity aerobic exercise will involve training at 70-80% heart rate reserve for 30 min, with an additional 10 minutes for warm-up and 5 minutes for cool-down, 4 times per week, for 12 months while supervised twice per week by a study-certified trainer at a participating YMCA .
  • Behavioral: Stretching/balance/range of motion exercise
    The stretching/balance/range of motion program will involve exercise at or below 35% heart rate reserve for 30 min, with an additional 10 minutes for warm up and 5 minutes for cool-down, 4 times per week, for 12 months while supervised twice per week by a study-certified trainer at a participating YMCA.
Study Arms  ICMJE
  • Experimental: Aerobic
    Moderate/high intensity aerobic exercise will involve training at 70-80% heart rate reserve for 30 min, with an additional 10 minutes for warm-up and 5 minutes for cool-down, 4 times per week, for 12 months while supervised twice per week by a study-certified trainer at a participating YMCA .
    Intervention: Behavioral: Aerobic exercise
  • Active Comparator: Stretching/balance/range of motion
    The stretching/balance/range of motion program will involve exercise at or below 35% heart rate reserve for 30 min, with an additional 10 minutes for warm up and 5 minutes for cool-down, 4 times per week, for 12 months while supervised twice per week by a study-certified trainer at a participating YMCA.
    Intervention: Behavioral: Stretching/balance/range of motion exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 65 and 89 years old, inclusive
  • Mini-Mental State Exam (MMSE): ≥24 for participants with 13 or more years of education; ≥22 for participants with 12 or fewer years of education
  • CDR =0.5
  • Impaired delayed verbal recall as indicated by scores meeting at least one of the following criteria: Logical Memory II ≤ 8; Auditory Verbal Learning Test, Trial 7 ≤4
  • Speaks English fluently
  • Visual and auditory acuity adequate for cognitive testing
  • Completed at least 6 years of formal education or work history sufficient to exclude mental retardation
  • Has an informant who knows the participant well, has at least weekly contact, and is available to accompany the participant to clinic visits
  • Sedentary or underactive, determined by responses to the staff-administered Telephone Assessment of Physical Activity (TAPA) survey
  • Willing to be randomized to either intervention group and to complete the assigned activities as specified for 18 months
  • Willing and able to reliably travel to the identified YMCA, 4 times per week for 18 months
  • Ability to safely participate in either intervention and complete the 400 m Walk Test within 15 min without sitting or use of any assistance
  • Plans to reside in the area for at least 18 months
  • For planned travel, total time away must be no more than 2 months over the course of the study, and no more than 1 month at any one time; participants must be willing to continue the assigned exercise program if travelling out of the area for more than 1 week
  • In overall good general health with no disease or planned surgery that could interfere with study participation
  • Modified Hachinski ≤4
  • Stable use of cholinesterase inhibitors, memantine, vitamin E (up to 400 IU daily), estrogens, aspirin (81 300 mg daily), beta-blockers, or cholesterol-lowering agents for 12 weeks prior to screening (important for biomarker analyses)
  • Stable use of antidepressants lacking significant anticholinergic side effects for 4 weeks prior to screening as long as the participant does not meet DSM V criteria for major depression currently or in the last 12 months; Geriatric Depression Score (GDS) scores are to be used to inform clinical decisions but there is no specified cut-off score for inclusion
  • When applicable, willing to complete 4-week washout of psychoactive medications, including disallowed antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, and willing to avoid these medications for the duration of the trial
  • Able to complete all baseline assessments

Exclusion Criteria:

  • Any significant neurologic disease, other than MCI, including any form of dementia, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities
  • Sensory or musculoskeletal impairment sufficient to preclude successful and safe completion of the intervention or assessment protocols; must be able to walk safely and unassisted on a treadmill
  • Contraindications for MRI studies, including claustrophobia, metal (ferromagnetic) implants, or cardiac pacemaker
  • Brain MRI at screening shows evidence of infection, infarction, or other clinically significant focal lesions, including multiple lacunes in prefrontal or critical memory regions; inconclusive findings may be subject to review by the ADCS Imaging Core
  • History of major depression or bipolar disorder (DSM V criteria), psychotic features, agitation or behavioral problems within the last 12 months
  • History of schizophrenia, as per DSM V criteria
  • History of alcohol or substance abuse or dependence within the past 2 years, as per DSM V criteria
  • Currently consumes more than 3 alcoholic drinks per day
  • Clinically significant or unstable medical condition, including uncontrolled hypertension or significant cardiac, pulmonary, hematologic, renal, hepatic, gastrointestinal, endocrine, metabolic or other systemic disease in the opinion of clinic medical personnel that may put the participant at increased risk, influence the results or compromise the participant's ability to participate in the study (treated atrial fibrillation for more than 1 year or occasional premature ventricular contractions on ECG are not exclusions)
  • History in the last 6 months of myocardial infarction, coronary artery angioplasty, bypass grafting, or STENT placement
  • History in the last 3 months of transient ischemic attack or small vessel stroke (if more than 3 months, small vessel stroke with no residual effects are permitted)
  • Expected joint replacement surgery within the next 18 months
  • History within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen posttreatment
  • Hemoglobin A1c >7.0
  • Clinically significant abnormalities in screening laboratory blood tests: low B12 is exclusionary, unless follow-up labs (homocysteine [HCY] and methylmalonic acid [MMA]) indicate that it is not physiologically significant
  • Current or past use of insulin to treat type 2 diabetes (other diabetes medications are acceptable if hemoglobin A1c ≤7)
  • Current use (within 60 days of screening) of psychoactive medications including tricyclic antidepressants, antipsychotics, mood-stabilizing psychotropic agents (e.g. lithium salts), psychostimulants, opiate analgesics, antiparkinsonian medications, anticonvulsant medications (except gabapentin and pregabalin for non-seizure indications), systemic corticosteroids, or medications with significant central anticholinergic activity. Limited use of antipsychotics (quetiapine ≤ 50mg/day or risperidone ≤ 0.5mg/day), and non-chronic use of opiate analgesics on an as needed basis is permitted; such medications must be avoided for 8 hours before clinic assessments
  • Chronic use of anxiolytics or sedative hypnotics except as follows: use of benzodiazepines for treatment on an as-needed basis for insomnia or daily dosing of anxiolytics is permitted; medications must be avoided for 8 hours before clinic assessments
  • Previous or current treatment involving active immunization against amyloid
  • Previous treatment with investigational agents with anti-amyloid properties or passive immunization against amyloid are prohibited 12 months prior to screening and for the duration of the trial; treatment with other investigational agents are prohibited 3 months prior to screening and for the duration of the trial
  • For lumbar puncture (LP), current use of anticoagulants such as Coumadin or Plavix
  • For LP, current blood clotting or bleeding disorder, or significantly abnormal prothrombin time (PT) or partial thromboplastin time (PTT) at screening
  • For LP, presence of physical distortions due to spinal surgery, severe degenerative joint disease or deformity, or obesity that could interfere with CSF collection (as per investigator judgment)
  • Participants whom the PI deems otherwise ineligible
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 89 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02814526
Other Study ID Numbers  ICMJE ADC-041-EX
U19AG010483-22 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Alzheimer's Disease Cooperative Study (ADCS)
Study Sponsor  ICMJE Alzheimer's Disease Cooperative Study (ADCS)
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • Wake Forest University
Investigators  ICMJE Not Provided
PRS Account Alzheimer's Disease Cooperative Study (ADCS)
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP