Investigating Gains in Neurocognition in an Intervention Trial of Exercise

NCT02875301 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 648

Last updated 2024-06-14

No results posted yet for this study

Summary

This randomized control trial will examine whether a 12 month monitored exercise intervention improves brain health in cognitively normal older adults. This trial will also address several important unanswered questions: (1) Are the recommended public health guidelines of 150 minutes/week of exercise sufficient for improving cognitive performance? (2) Does exercise influence brain structure and/or function? (3) Is there a dose-response effect of exercise on the above variables such that greater amounts of exercise brings about greater benefits in cognitive and brain health? (4) What are the mechanisms by which exercise influences brain health? and (5) What factors attenuate or magnify the effects of exercise on brain and cognitive health and contribute to the individual variability in intervention outcomes?

Conditions

  • Healthy
  • Cognitive Function 1, Social

Interventions

BEHAVIORAL

150 Minutes Week

This group will complete aerobic based exercise 150 minutes per week. Participants will obtain minutes through supervised on site exercise and home based exercise. An exercise duration of 30 minutes will be achieved by the forth week of the program and be maintained for the duration of the intervention. Heart rate will be monitored to ensure proper intensity levels. Participants will also be instructed to exercise at home for 30 minutes for two other days of the week at a similar intensity. The prescribed intensity will be 50-60% of the maximum heart rate reserve for weeks one to six and 60-75% for the remainder of the program. Participants in the walking conditions will wear heart rate monitors and be encouraged to walk within their target heart rate zone. During the Covid-19 pandemic shutdown, all intervention exercise was been shifted to home based.

BEHAVIORAL

225 Minutes Week

This group will complete aerobic based exercise 225 minutes per week. Participants will obtain minutes through supervised on site exercise and home base exercise. A walking duration of 45 minutes will be achieved by the seventh week of the program. This will be maintained for the duration of the intervention and heart rate will be monitored to ensure proper intensity levels. Participants will be instructed to exercise at home for 45 minutes for two other days of the week at a similar intensity. The prescribed intensity will be 50-60% of the maximum heart rate reserve for weeks one to six and 60-75% for the remainder of the program. Participants in the walking conditions will wear heart rate monitors and be encouraged to walk within their target heart rate zone. During the Covid-19 pandemic shutdown, all intervention exercise has been shifted to home based.

BEHAVIORAL

Stretch and Tone

The control condition will focus on improving balance, flexibility, and strength. This group will obtain 150 minutes per week via in person sessions, zoom sessions and home based stretching. Resistance bands, balance disks, yoga blocks, and exercise mats will be used to engage in non-cardiorespiratory activities. These are progressive in nature and include modifications to accommodate injuries, physical difficulties, etc. A new set of similar, yet slightly more challenging activities will be introduced every four weeks. During the first two weeks, participants are introduced to the new activities, and, during the second two weeks, they are encouraged to increase intensity by using more weight or more repetitions. During the current Covid-19 pandemic, all intervention exercise has been shifted to home based.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • National Institute on Aging (NIA)

    collaborator NIH
  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Kirk I Erickson, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2023-04-11
Completion
2023-04-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02875301 on ClinicalTrials.gov