- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02600572
Changes in Attention Level Due to Isometric Exercises and Level Three Progression Eccentric Movements
February 16, 2017 updated by: Carrick Institute for Graduate Studies
Determine the changes in attention level due to isometric exercises and level three progression eccentric movements.
The attention level will be measured using a mental speed test (how quickly a subject can process information and make decisions based upon that information).
Another outcome measure will be the ability of the subject to maintain balance
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
On Day 1, subjects will complete the mental speed test and will undergo CDP testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface (a 4" tall foam cushion of known mechanical properties) in a comfortable posture, feet shoulder width, with eyes open or closed, head straight and arms to the side and free to move, gazing forward, and breathing normally.
These will constitute the baseline information.
Subjects will be divided into two groups: a isometric group (performing the isometric exercises) and an eccentric group (performing the eccentric exercises).
At the end of Day 1, the isometric group will perform the isometric exercises while the eccentric group will act as control (no exercise).
On Day 2, subjects will complete the mental speed test and will undergo the CDP testing a second time.
These will constitute the first follow-up information.
At the end of Day 2, the eccentric group will perform the eccentric exercises while the isometric group will act as control (no exercise).
Throughout Day 3, subjects will complete the mental speed test and undergo the CDP testing a third time.
This will constitute the second and last follow-up information.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Cape Canaveral, Florida, United States, 32920
- Carrick Institute for Graduate Studies
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy individuals
Exclusion Criteria:
- Any pathology preventing the subject to safely perform the isometric exercises (the clinician enrolling the subjects will make the decision)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Isometric exercise
Subjects performing the isometric exercises intervention
|
Subjects will perform one session of isometric exercises at the end of Day 1
|
Experimental: Eccentric exercise
Subjects performing the eccentric exercises intervention
|
Subjects will perform one session of eccentric exercises at the end of Day 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Stability Score
Time Frame: Baseline, Day 2 and Day 3
|
The Stability Score is calculated as percentage ratio of the actual sway and the theoretical limit of stability. Changes in Stability Score will be assessed between baseline (Day 1), and Day 2 and Day 3. It will be used to investigate if and which exercises affect it and how much. |
Baseline, Day 2 and Day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Mental Speed
Time Frame: Baseline, Day 2 and Day 3
|
The subject will be presented a series of word/image pairs and/or simple mathematical equations or number sequences.
If a pair matches, the subject has to click the "Correct" button, if the pair does not match, the "Incorrect" button .
However, if the word "Opposite" appears at the top of the screen, the answer needs to be reversed.
The subject has up to 5 minutes to complete the task.
The Accuracy of the answers expressed as percentage will be used as measure of mental speed.
Changes in Accuracy will be assessed between baseline (Day 1), and Day 2 and Day 3. It will be used to investigate if and which exercises affect it and how much.
|
Baseline, Day 2 and Day 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
November 6, 2015
First Submitted That Met QC Criteria
November 6, 2015
First Posted (Estimate)
November 9, 2015
Study Record Updates
Last Update Posted (Actual)
February 20, 2017
Last Update Submitted That Met QC Criteria
February 16, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CI-IRB-20151104003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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