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Withdrawn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

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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