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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Exercise, Isometric

Intervention / Treatment
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* Other: Isometric exercises
* Other: No exercise


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Isometric exercise<br>Subjects performing the isometric exercises intervention | Other: Isometric exercises<br>* subjects will perform specific isometric exercises for 10-20 minutes, three times a week throughout the enrollment period<br>|
| Active Comparator: No exercise<br>Subjects not performing the isometric exercises intervention | Other: No exercise<br>* Subjects will go on with their life without any specific isometric exercise regimen during the enrollment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balance, postural, postural equilibrium, heart rate, blood pressure, pulse oxygenation, mental speed