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

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).

Study Overview

• Status: Withdrawn
• Conditions: Exercise, Isometric
• Intervention / Treatment: Other: Isometric exercises; Other: No exercise

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Cape Canaveral, Florida, United States, 32920
      • Carrick Institute for Graduate Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Carrick Institute for Graduate Studies

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 5, 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

• Keywords: blood pressure; heart rate; balance, postural; postural equilibrium; pulse oxygenation; mental speed
• Other Study ID Numbers: CI-IRB-20151104002