Effects of Isometric Exercises on Balance, Heart Rate, Pulse Ox and Blood Pressure

Exercise, Isometric Clinical Trial

Official title:

Effects of Isometric Exercises on Balance, Heart Rate, Pulse Ox and Blood Pressure

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02599727
• Other study ID #: CI-IRB-20151104002
• Status: Withdrawn
• Phase: N/A
• First received: November 5, 2015
• Last updated: February 16, 2017
• Start date: November 2015
• Est. completion date: January 2017

Study information

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

Clinical Trial Summary

Determine the effects repeated isometric exercises have on balance, blood pressure, heart rate and pulse ox. Another outcome measure will be a mental speed test (how quickly a subject can process information and make decisions based upon that information).

Description:

Subjects will complete a mental speed test and will undergo Computerized Dynamic Posturography (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. Immediately prior to the CDP testing, subjects will have their heart rate, blood pressure and pulse Ox measured. These will constitute the baseline information.

Subjects will then be divided into two groups: the isometric exercise group (they will be instructed to perform specific isometric exercises three times a week, for the next 8 weeks) and the control group (no exercises will be prescribe to them).

The same testing procedure indicated above will be followed at the end of the 8 weeks. The mental speed test, CDP testing, heart rate, blood pressure and pulse Ox will constitute the 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• Status: Withdrawn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)

Related Conditions & MeSH terms

• Exercise, Isometric

Intervention

Other:
• Isometric exercises
subjects will perform specific isometric exercises for 10-20 minutes, three times a week throughout the enrollment period
• No exercise
Subjects will go on with their life without any specific isometric exercise regimen during the enrollment period

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 Heart Rate	Changes in heart rate at rest will be assessed between baseline (at enrollment) and after the treatment period. It will be used to investigate if isometric exercises affect it and how much.	Baseline and at 8 weeks
Secondary	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 (at enrollment) and after the treatment period. It will be used to investigate if isometric exercises affect it and how much.	Baseline and at 8 weeks
Secondary	Changes in Blood Pressure	Changes in Blood pressure (measured in standard conditions) will be assessed between baseline (at enrollment) and after the treatment period. It will be used to investigate if isometric exercises affect it and how much.	Baseline and at 8 weeks
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 asnwer 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 (at enrollment) and after the treatment period. It will be used to investigate if isometric exercises affect it and how much.	Baseline and at 8 weeks