Osteopathy Treatment and Cardiovascular Recovery After a Rugby Match

January 22, 2020 updated by: Elena Giovanna Bignami, University of Parma

Osteopathy Treatment Restores Cardiovascular Autonomic Parameters in Rugby Players

The purpose of this study was to explore the efficacy of osteopathic manipulative treatment (OMT), a form of non-invasive manual treatment, for a faster recovery of cardiovascular parameters after a rugby union match in professional male athletes. To this end, the effects of OMT on resting cardiovascular function and cardiovascular reactivity were evaluated in twenty-three male players 18-20 hours after a match and compared with a corresponding no-match (control) condition. Assessment of resting cardiovascular parameters 18-20 hours after a match revealed the presence of elevated mean arterial pressure and heart rate, and reduced vagally-mediated heart rate variability compared with a no-match condition. OMT provoked a significant reduction in mean arterial pressure and increased vagally-mediated heart rate variability at rest both in the after match and control conditions. Moreover, OMT favoured a larger vagal withdrawal in response to an orthostatic stress compared with a sham treatment. These results suggest that OMT may be implemented as a recovery strategy to restore athletes' cardiovascular homeostasis after a rugby union match.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The presence of cardiovascular autonomic alterations in the aftermath of an intense exercise performed during a competitive match may indicate incomplete recovery and prolonged fatigue.Therefore, the implementation of effective interventions aimed at favoring a faster recovery of athletes' cardiovascular homeostasis in the aftermath of a competitive match may be beneficial for greater adaptations to subsequent training and enhanced overall performance. In this regard, osteopathic manipulative treatment (OMT) is a form of non-invasive manual treatment that uses a set of touch, manipulation and mobilization procedures to diagnose, treat, and prevent illness or injury. In the present study, the investigators sought to explore the efficacy of a single session of OMT in restoring alterations in cardiovascular parameters at rest and in response to an orthostatic challenge in trained adult male athletes long after (18-20 hours) a rugby union match.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Italy
      • Parma, Italy
        • Collegio Italiano di Osteopatia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • being healthy and injury-free
  • age ≥ 18 years old
  • being Caucasian
  • regular participation in competitive matches of rugby union consisting of 2, 40-min halves
  • regular training for an average of six hours/week during the last four weeks

Exclusion Criteria:

  • history of cardiovascular disease or traumatic brain injury
  • chronic drug treatment
  • use of any medications during the last week
  • having received osteopathic manipulative treatment before

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: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: AFTER MATCH + OMT
Players undertook a recording session the day after a rugby match and received osteopathic manipulative treatment
Other: Osteopathic manipulative treatment
Each osteopathic manipulative treatment consisted of a structured evaluation to diagnose somatic dysfunction of the pelvis, abdomen, vertebral spine, and upper and lower limbs (10 min), followed by the therapeutic application of manually guided forces to improve physiological function and homeostasis that has been altered by somatic dysfunction for 20 min, using techniques that were left at the discretion of the osteopath, including the myofascial release and cranial sacrum techniques
OTHER: AFTER MATCH + sham treatment
Players undertook a recording session the day after a rugby match and received sham treatment
Other: Sham treatment
The sham treatment consisted only in "soft touch" of the same body areas involved in the osteopathic manipulative treatment protocol without applying any pressure
OTHER: NO MATCH + OMT
Players undertook a recording session the day after a resting day and received osteopathic manipulative treatment
Other: Osteopathic manipulative treatment
Each osteopathic manipulative treatment consisted of a structured evaluation to diagnose somatic dysfunction of the pelvis, abdomen, vertebral spine, and upper and lower limbs (10 min), followed by the therapeutic application of manually guided forces to improve physiological function and homeostasis that has been altered by somatic dysfunction for 20 min, using techniques that were left at the discretion of the osteopath, including the myofascial release and cranial sacrum techniques
OTHER: NO MATCH + sham treatment
Players undertook a recording session the day after a resting day and received sham treatment
Other: Sham treatment
The sham treatment consisted only in "soft touch" of the same body areas involved in the osteopathic manipulative treatment protocol without applying any pressure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Resting heart rate
Time Frame: ECG recorded for 10 min just before osteopathic manipulative treatment and sham treatment
Mean heart rate measured as beats per minute
ECG recorded for 10 min just before osteopathic manipulative treatment and sham treatment
Resting heart rate
Time Frame: ECG recorded for 5 min just after osteopathic manipulative treatment and sham treatment
Mean heart rate measured as beats per minute
ECG recorded for 5 min just after osteopathic manipulative treatment and sham treatment
Resting heart rate variability (RMSSD index)
Time Frame: ECG recorded for 10 min just before osteopathic manipulative treatment and sham treatment
Root mean square of the successive differences between adjacent heart beats (RMSSD) measured in ms
ECG recorded for 10 min just before osteopathic manipulative treatment and sham treatment
Resting heart rate variability (RMSSD index)
Time Frame: ECG recorded for 5 min just after osteopathic manipulative treatment and sham treatment
Root mean square of the successive differences between adjacent heart beats (RMSSD) measured in ms
ECG recorded for 5 min just after osteopathic manipulative treatment and sham treatment
Resting heart rate variability (HF index)
Time Frame: ECG recorded for 10 min just before osteopathic manipulative treatment and sham treatment
High frequency (HF) component power of the RR interval spectrum measured in ms2
ECG recorded for 10 min just before osteopathic manipulative treatment and sham treatment
Resting heart rate variability (HF index)
Time Frame: ECG recorded for 5 min just after osteopathic manipulative treatment and sham treatment
High frequency (HF) component power of the RR interval spectrum measured in ms2
ECG recorded for 5 min just after osteopathic manipulative treatment and sham treatment
Resting mean arterial pressure
Time Frame: Assessed just before osteopathic manipulative treatment and sham treatment with a sphygmomanometer
Mean arterial pressure measured in mmHg
Assessed just before osteopathic manipulative treatment and sham treatment with a sphygmomanometer
Resting mean arterial pressure
Time Frame: Assessed just after osteopathic manipulative treatment and sham treatment with a sphygmomanometer
Mean arterial pressure measured in mmHg
Assessed just after osteopathic manipulative treatment and sham treatment with a sphygmomanometer

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart rate reactivity to orthostasis
Time Frame: ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)
Mean heart rate measured as beats per minute
ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)
Heart rate variability (RMSSD index) reactivity to orthostasis
Time Frame: ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)
Root mean square of the successive differences between adjacent heart beats measured in ms
ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)
Heart rate variability (HF index) reactivity to orthostasis
Time Frame: ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)
High frequency component power of the RR interval spectrum measured in ms2
ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Parma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Collegio Italiano di Osteopatia
Foundation COME Collaboration

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 (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 032017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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