Exercise, IsometricNCT02599727
Effects of Isometric Exercises on Balance, Heart Rate, Pulse Ox and Blood Pressure
A study testing Isometric exercises and No exercise in people with Exercise, Isometric, run by Carrick Institute for Graduate Studies at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exercise, Isometric
- What is being tested?
- Isometric exercises and No exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals
Who cannot join
- Any pathology preventing the subject to safely perform the isometric exercises (the clinician enrolling the subjects will make the decision)
Trial locations and contacts
1 site in 1 country.
United States1 site
Carrick Institute for Graduate Studies
Cape Canaveral, Florida, 32920
About this study
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).
Read the 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.
- Conditions
- Exercise, Isometric
- Being tested
- Isometric exercises, No exercise
- Keywords
- balance, postural, postural equilibrium, heart rate, blood pressure, pulse oxygenation, mental speed
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exercisesOther
subjects will perform specific isometric exercises for 10-20 minutes, three times a week throughout the enrollment period
No exerciseOther
Subjects will go on with their life without any specific isometric exercise regimen during the enrollment period
| Study group | Role | What they receive |
|---|---|---|
| Active Isometric exercise | Experimental | Subjects performing the isometric exercises intervention Receives: Other: Isometric exercises |
| No exercise | Active comparator | Subjects not performing the isometric exercises intervention Receives: Other: No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 8 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Logistics reason at the data collection site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise, IsometricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carrick Institute for Graduate Studies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies
- Investigators
- Frederick R Carrick, PhD, Principal investigator, Carrick Institute for Graduate Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599727
- Sponsor's protocol ID
- CI-IRB-20151104002
- Status last verified
- Feb 2017
- First submitted
- 5 Nov 2015
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Isometric Exercises on Balance, Heart Rate, Pulse Ox and Blood Pressure
- ClinicalTrials.gov ID
- NCT02599727
- Acronym / sponsor ID
- CI-IRB-20151104002
- Conditions
- Exercise, Isometric
- Keywords
- balance, postural, postural equilibrium, heart rate, blood pressure, pulse oxygenation, mental speed
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistics reason at the data collection site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carrick Institute for Graduate StudiesUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Isometric exercise | Experimental | Other: Isometric exercisesSubjects performing the isometric exercises intervention |
| No exercise | Active comparator | Other: No exerciseSubjects not performing the isometric exercises intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy individuals
Key exclusion criteria (1 listed)
- Any pathology preventing the subject to safely perform the isometric exercises (the clinician enrolling the subjects will make the decision)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric exercisessubjects will perform specific isometric exercises for 10-20 minutes, three times a week throughout the enrollment period | Other | Active Isometric exercise |
| No exerciseSubjects will go on with their life without any specific isometric exercise regimen during the enrollment period | Other | No exercise |
Primary outcome
Changes in Heart Rate
Time frame: Baseline and at 8 weeks
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.
3 secondary outcomes
Changes in Stability Score
Time frame: Baseline and at 8 weeks
Changes in Blood Pressure
Time frame: Baseline and at 8 weeks
Changes in Mental Speed
Time frame: Baseline and at 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick R Carrick, PhD principal investigator
Carrick Institute for Graduate Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercises and No exercise in people with Exercise, Isometric, run by Carrick Institute for Graduate Studies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Heart Rate (time frame: Baseline and at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2017.