Exercise in Adults With Mild Memory Problems
Condition: Mild Cognitive Impairment; Cognitive Decline; Memory Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

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: 
      Overall Study Design:

      The EXERT trial was a multicenter phase 3 randomized, single-blind study that examined the
      effects of aerobic exercise on cognition, functional status, whole and regional cerebral
      blood flow, and cerebrospinal fluid biomarkers of Alzheimer's disease in approximately 300
      adults with amnestic MCI. EXERT included an 18-month behavioral intervention trial, with a
      12-month supervised exercise intervention phase with its primary endpoints, followed by a
      6-month unsupervised exercised phase.

      Subject Populations and Group Assignments:

      The study population included male and female subjects aged 65 to 89 diagnosed with test
      scores and clinical ratings consistent with amnestic Mild Cognitive Impairment (MCI).

      Assignment to study groups:

      involved randomization to either treatment or active control, and study staff performing
      assessments were blinded to intervention assignment to maintain the single-blind structure of
      the trial.

      Participants were to complete EXERT interventions at participating YMCAs located near the
      selected clinic sites across the U.S. The YMCA provided 18-month memberships at no cost to
      participants. In the first 12 months, a study-certified YMCA Trainer supervised all
      participants for the first 8 exercise sessions completed (weeks 1 and 2), and for 2 of 4
      weekly sessions thereafter through Month 12. At Month 12, participants transitioned to
      independent exercise and were instructed to continue their assigned exercise programs for the
      final 6 months of the study without supervision. To encourage adherence and optimize cost
      efficiency, Trainers provided supervision to small groups of participants (2-4 individuals)
      randomized to the same intervention whenever possible. Compliance was evaluated using
      multiple mechanisms including heart rate monitoring, participant ratings of perceived
      exertion, entries in participants' Physical Activity Logs, Trainer assessment of effort, and
      weekly data review by the YMCA-Project Manager (Y-PM) and the Intervention Oversight Team
      (includes the Project Directors, Wake Forest team of exercise trial specialists, and Y-USA).
      These mechanisms provided multiple and regular opportunities to discuss participant progress,
      identify and resolve barriers, and encourage high levels of adherence to study protocols. The
      Intervention Oversight Team had the necessary expertise to successfully accomplish this
      objective in EXERT.
    

Intervention name(s): Aerobic exercise; Stretching/balance/range of motion exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 .; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise