Cardiovascular Physiological PhenomenaNCT04242485
Osteopathy Treatment and Cardiovascular Recovery After a Rugby Match
A study testing Osteopathic manipulative treatment in people with Cardiovascular Physiological Phenomena, run by University of Parma at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Physiological Phenomena
- What is being tested?
- Osteopathic manipulative treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2017to 1 May 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Physiological Phenomena
- Being tested
- Osteopathic manipulative treatment, Sham treatment
- Keywords
- heart rate, heart rate variability, blood pressure, rugby match, atlethes, recovery, osteopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative treatmentOther
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
Sham treatmentOther
The sham treatment consisted only in "soft touch" of the same body areas involved in the osteopathic manipulative treatment protocol without applying any pressure
| Study group | Role | What they receive |
|---|---|---|
| AFTER MATCH + OMT | Other | Players undertook a recording session the day after a rugby match and received osteopathic manipulative treatment Receives: Other: Osteopathic manipulative treatment |
| AFTER MATCH + sham treatment | Other | Players undertook a recording session the day after a rugby match and received sham treatment Receives: Other: Sham treatment |
| NO MATCH + OMT | Other | Players undertook a recording session the day after a resting day and received osteopathic manipulative treatment Receives: Other: Osteopathic manipulative treatment |
| NO MATCH + sham treatment | Other | Players undertook a recording session the day after a resting day and received sham treatment Receives: Other: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting heart rate
Mean heart rate measured as beats per minute
Measured: ECG recorded for 10 min just before osteopathic manipulative treatment and sham treatment
Resting heart rate
Mean heart rate measured as beats per minute
Measured: ECG recorded for 5 min just after osteopathic manipulative treatment and sham treatment
Resting heart rate variability (RMSSD index)
Root mean square of the successive differences between adjacent heart beats (RMSSD) measured in ms
Measured: ECG recorded for 10 min just before osteopathic manipulative treatment and sham treatment
Resting heart rate variability (RMSSD index)
Root mean square of the successive differences between adjacent heart beats (RMSSD) measured in ms
Measured: ECG recorded for 5 min just after osteopathic manipulative treatment and sham treatment
Resting heart rate variability (HF index)
High frequency (HF) component power of the RR interval spectrum measured in ms2
Measured: ECG recorded for 10 min just before osteopathic manipulative treatment and sham treatment
Resting heart rate variability (HF index)
High frequency (HF) component power of the RR interval spectrum measured in ms2
Measured: ECG recorded for 5 min just after osteopathic manipulative treatment and sham treatment
Resting mean arterial pressure
Mean arterial pressure measured in mmHg
Measured: Assessed just before osteopathic manipulative treatment and sham treatment with a sphygmomanometer
Resting mean arterial pressure
Mean arterial pressure measured in mmHg
Measured: Assessed just after osteopathic manipulative treatment and sham treatment with a sphygmomanometer
Secondary outcomes (3)
Heart rate reactivity to orthostasis
Mean heart rate measured as beats per minute
Measured: ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)
Heart rate variability (RMSSD index) reactivity to orthostasis
Root mean square of the successive differences between adjacent heart beats measured in ms
Measured: ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)
Heart rate variability (HF index) reactivity to orthostasis
High frequency component power of the RR interval spectrum measured in ms2
Measured: ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Oct 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Physiological PhenomenaStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Collaborators
- Collegio Italiano di Osteopatia, Foundation COME Collaboration
- Responsible party
- Principal investigator, Elena Giovanna Bignami, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242485
- Sponsor's protocol ID
- 032017
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathy Treatment Restores Cardiovascular Autonomic Parameters in Rugby Players
- ClinicalTrials.gov ID
- NCT04242485
- Acronym / sponsor ID
- 032017
- Conditions
- Cardiovascular Physiological Phenomena
- Keywords
- heart rate, heart rate variability, blood pressure, rugby match, atlethes, recovery, osteopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Collaborators
- Collegio Italiano di Osteopatia, Foundation COME Collaboration
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 27 Jan 2020 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AFTER MATCH + OMT | Other | Other: Osteopathic manipulative treatmentPlayers undertook a recording session the day after a rugby match and received osteopathic manipulative treatment |
| AFTER MATCH + sham treatment | Other | Other: Sham treatmentPlayers undertook a recording session the day after a rugby match and received sham treatment |
| NO MATCH + OMT | Other | Other: Osteopathic manipulative treatmentPlayers undertook a recording session the day after a resting day and received osteopathic manipulative treatment |
| NO MATCH + sham treatment | Other | Other: Sham treatmentPlayers undertook a recording session the day after a resting day and received sham treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Osteopathic manipulative treatmentEach 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 + OMT, NO MATCH + OMT |
| Sham treatmentThe sham treatment consisted only in "soft touch" of the same body areas involved in the osteopathic manipulative treatment protocol without applying any pressure | Other | AFTER MATCH + sham treatment, NO MATCH + sham treatment |
Primary outcome
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
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
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
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
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
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
Resting mean arterial pressure
Time frame: Assessed just before osteopathic manipulative treatment and sham treatment with a sphygmomanometer
Mean arterial pressure measured in mmHg
Resting mean arterial pressure
Time frame: Assessed just after osteopathic manipulative treatment and sham treatment with a sphygmomanometer
Mean arterial pressure measured in mmHg
3 secondary outcomes
Heart rate reactivity to orthostasis
Time frame: 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)
Heart rate variability (HF index) reactivity to orthostasis
Time frame: ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)
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 27 Jan 2020.
- Individual participant dataSharing planned: No
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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 Osteopathic manipulative treatment in people with Cardiovascular Physiological Phenomena, run by University of Parma at 1 site in Italy.
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 5 inclusion and 4 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 27 Jan 2020. 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 Italy. 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 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?
Resting heart rate (time frame: ECG recorded for 10 min just before osteopathic manipulative treatment and sham treatment). The study lists 8 primary outcomes in all. 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 27 Jan 2020.