- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02543008
Effect of Physical Activity Following Thoracic Mobilization on Heart Rate Variability and Pressure Pain Threshold.
February 13, 2017 updated by: Francisco Xavier de Araujo, Pt, Federal University of Health Science of Porto Alegre
Effect of Physical Activity Following Thoracic Mobilization on Heart Rate Variability and Pressure Pain Threshold in Asymptomatic Subjects: a Randomized Clinical Trial.
Comparison of the effects of physical activity (treadmill running) plus thoracic mobilization, physical activity only or a placebo intervention (only manual contact thoracic mobilization), on heart rate variability and pressure pain threshold.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90160240
- Universidade Federal de Ciências da Saúde
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Asymptomatic subjects
- Sedentary
Exclusion Criteria:
- Spinal pain
- Historic of trauma/surgery to the spine
- Diabetes
- Hypo/hyperthyroidism
- Alcoholic
- Smoker
- Hypertension
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical activity plus thoracic mobilization
Subjects randomly allocated to this arm will be submitted to a 10 minutes anaerobic exercise (2 minutes warming up, 5 minutes of 75% to 85% maximal heat rate, 3 minutes slowdown), followed by 5 minutes of passive intervertebral thoracic mobilization (3 sets of 1 minute, grade III, and 1 minute rest between each set).
|
Information already included in arm/group descriptions.
|
Active Comparator: Physical activity
Subjects allocated to this arm will be submitted to the same anaerobic exercise protocol, without the thoracic mobilization.
|
Information already included in arm/group descriptions.
|
Placebo Comparator: Placebo
Subjects in this group will be conducted to a placebo thoracic mobilization, without anaerobic exercise protocol.
The investigator will apply only a manual contact, to mimic the genuine thoracic mobilization.
The same 5 minutes period will be respected, and the same position of therapist and subject.
|
Information already included in arm/group descriptions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate variability
Time Frame: Change from baseline, immediately after, and 15 minutes after the intervention.
|
Change from baseline, immediately after, and 15 minutes after the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure pain threshold
Time Frame: Change from baseline, mimediately after, and 15 minutes after the intervention.
|
Digital algometer will be applied to C7 and T4 spinous process, right hand and right tibialis anterior muscle belly
|
Change from baseline, mimediately after, and 15 minutes after the intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
September 2, 2015
First Submitted That Met QC Criteria
September 4, 2015
First Posted (Estimate)
September 7, 2015
Study Record Updates
Last Update Posted (Actual)
February 14, 2017
Last Update Submitted That Met QC Criteria
February 13, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FUHSPortoAlegre_II
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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