Effects of Exercise on Memory in Healthy and Brain-Injured Individuals
|ClinicalTrials.gov Identifier: NCT01939769|
Recruitment Status : Terminated
First Posted : September 11, 2013
Last Update Posted : August 30, 2017
- Research has shown that one exercise session may improve a person s ability to recall information they learned before the exercise. Knowing how exercise changes brain activity to improve memory can help researchers understand how memory works and how to improve it in people with memory problems. This study compares two kinds of exercise on a stationary bike for their ability to temporarily improve memory on certain tests. Researchers will look at the effect of exercise on body chemistry by drawing blood and collecting saliva.
- To understand how a single session of exercise affects memory testing in healthy people and people who have had traumatic brain injury (TBI).
- Adults ages 18 through 45 with TBI.
- Healthy adult volunteers, ages 18 through 45.
- Participants will be screened with medical history and physical exam. This will take about 1 hour.
- Participants with TBI will also be screened with a test of their memory. This will take another hour.
- Visit 1 will take about 3 hours. Participants will:
<TAB>- Have a tube inserted in their arm for drawing blood during the tests.
<TAB>- Take memory tests. They will look at pictures, symbols, and words, then answer questions.
<TAB>- Give a saliva sample by chewing on a small sponge for 2 minutes.
<TAB>- Exercise on a stationary bike.
<TAB>- Take the memory tests again.
- Visit 2 will take place 1 week later. Participants will take the memory tests only.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Other: Exercise - Low-intensity exercise Other: Exercise - High-intensity exercise||Phase 1|
Objective: The goals of this study are to 1. replicate the finding that exercise after exposure to images enhances their subsequent recall, 2. extend the question to words and logical rules, 3. examine the mechanism of the effect using exercise biomarkers and fMRI and 4. explore its usefulness as an aid to memory in individuals with traumatic brain injury (TBI).
Study population: Healthy adult volunteers and individuals with TBI.
Design: The main, clinical, experiment has a parallel, repeated-measures design, where four groups (two each of healthy subjects and participants with TBI) will encode pictures, words and rules and then exercise at either a high or very low (placebo) intensity. Recall will be tested one hour and again at seven days after exercise. Blood and saliva will be collected before and immediately after exercise and assayed for biomarkers of exercise, thought to be possible mediators of the memory effect. In a parallel-design fMRI experiment, intended to explore the brain basis of the effect of exercise on memory, healthy volunteers will view pictures, exercise at a high or low intensity, and then perform a recall task in the scanner. The analysis will look for differences in location and extent of evoked brain activations evoked by picture recall after low and high intensity exercise.
Outcome measures: The primary outcome measure is recall of visual material one hour after exercise. Secondary measures will be the recall of word lists and letter/digit symbol matching (logical memory) and activations on fMRI. The blood and saliva biomarkers will are included as exploratory outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Acute Effects of Exercise on Memory in Healthy and Brain-Injured Individuals|
|Study Start Date :||August 31, 2013|
|Primary Completion Date :||May 21, 2015|
|Study Completion Date :||August 28, 2017|
- Recall of pictures [ Time Frame: 2 years ]
- Recall of word lists [ Time Frame: 2 years ]
- Digit-symbol substitution performance [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939769
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Eric M Wassermann, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|