NCT02599727

Brief 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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

November 5, 2015

Last Update Submit

February 16, 2017

Conditions

Keywords

balance, posturalpostural equilibriumheart rateblood pressurepulse oxygenationmental speed

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in Stability Score

    Baseline and at 8 weeks

  • Changes in Blood Pressure

    Baseline and at 8 weeks

  • Changes in Mental Speed

    Baseline and at 8 weeks

Study Arms (2)

Active Isometric exercise

EXPERIMENTAL

Subjects performing the isometric exercises intervention

Other: Isometric exercises

No exercise

ACTIVE COMPARATOR

Subjects not performing the isometric exercises intervention

Other: No exercise

Interventions

subjects will perform specific isometric exercises for 10-20 minutes, three times a week throughout the enrollment period

Active Isometric exercise

Subjects will go on with their life without any specific isometric exercise regimen during the enrollment period

No exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals

You may not qualify if:

  • Any pathology preventing the subject to safely perform the isometric exercises (the clinician enrolling the subjects will make the decision)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carrick Institute for Graduate Studies

Cape Canaveral, Florida, 32920, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Frederick R Carrick, PhD

    Carrick Institute for Graduate Studies

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 9, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations