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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02600572
Other study ID # CI-IRB-20151104003
Secondary ID
Status Withdrawn
Phase N/A
First received November 6, 2015
Last updated February 16, 2017
Start date January 2016
Est. completion date January 2017

Study information

Verified date February 2017
Source Carrick Institute for Graduate Studies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Isometric exercises
Subjects will perform one session of isometric exercises at the end of Day 1
Eccentric exercises
Subjects will perform one session of eccentric exercises at the end of Day 2

Locations

Country Name City State
United States Carrick Institute for Graduate Studies Cape Canaveral Florida

Sponsors (1)

Lead Sponsor Collaborator
Carrick Institute for Graduate Studies

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Stability Score 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 Changes in Mental Speed 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
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