HealthyNCT02543008
Effect of Physical Activity Following Thoracic Mobilization on Heart Rate Variability and Pressure Pain Threshold.
A study testing Physical activity plus thoracic mobilization and Physical activity in people with Healthy, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Physical activity plus thoracic mobilization and Physical activity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to Nov 2015
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic subjects
- Sedentary
Who cannot join
- Spinal pain
- Historic of trauma/surgery to the spine
- Diabetes
- Hypo/hyperthyroidism
- Alcoholic
- Smoker
- Hypertension
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Ciencias da Saude
Porto Alegre, Rio Grande do Sul, 90160240
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Physical activity plus thoracic mobilization, Physical activity, Placebo
- Keywords
- Asymptomatic individuals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity plus thoracic mobilizationProcedure or surgery
Information already included in arm/group descriptions.
Physical activityProcedure or surgery
Information already included in arm/group descriptions.
PlaceboProcedure or surgery
Information already included in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity plus thoracic mobilization | Experimental | 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). Receives: Procedure: Physical activity plus thoracic mobilization |
| Physical activity | Active comparator | Subjects allocated to this arm will be submitted to the same anaerobic exercise protocol, without the thoracic mobilization. Receives: Procedure: Physical activity |
| Placebo | Placebo comparator | 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. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Measured: Change from baseline, immediately after, and 15 minutes after the intervention.
Secondary outcomes (1)
Pressure pain threshold
Digital algometer will be applied to C7 and T4 spinous process, right hand and right tibialis anterior muscle belly
Measured: Change from baseline, mimediately after, and 15 minutes after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Xavier de Araujo, Pt, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543008
- Sponsor's protocol ID
- FUHSPortoAlegre_II
- Status last verified
- Feb 2017
- First submitted
- 2 Sep 2015
- Last updated
- 14 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity Following Thoracic Mobilization on Heart Rate Variability and Pressure Pain Threshold in Asymptomatic Subjects: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02543008
- Acronym / sponsor ID
- FUHSPortoAlegre_II
- Conditions
- Healthy
- Keywords
- Asymptomatic individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Sep 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical activity plus thoracic mobilization | Experimental | Procedure: Physical activity plus thoracic mobilizationSubjects 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). |
| Physical activity | Active comparator | Procedure: Physical activitySubjects allocated to this arm will be submitted to the same anaerobic exercise protocol, without the thoracic mobilization. |
| Placebo | Placebo comparator | Procedure: PlaceboSubjects 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Asymptomatic subjects
- Sedentary
Key exclusion criteria (7 listed)
- Spinal pain
- Historic of trauma/surgery to the spine
- Diabetes
- Hypo/hyperthyroidism
- Alcoholic
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 |
|---|---|---|
| Physical activity plus thoracic mobilizationInformation already included in arm/group descriptions. | Procedure or surgery | Physical activity plus thoracic mobilization |
| Physical activityInformation already included in arm/group descriptions. | Procedure or surgery | Physical activity |
| PlaceboInformation already included in arm/group descriptions. | Procedure or surgery | Placebo |
Primary outcome
Heart rate variability
Time frame: Change from baseline, immediately after, and 15 minutes after the intervention.
1 secondary outcome
Pressure pain threshold
Time frame: Change from baseline, mimediately after, and 15 minutes after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity plus thoracic mobilization and Physical activity in people with Healthy, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 14 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 Brazil. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart rate variability (time frame: Change from baseline, immediately after, and 15 minutes after the intervention.). 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 14 Feb 2017.