- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04242485
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
26
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
-
-
-
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
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 |
Intervention / Treatment |
---|---|
OTHER: AFTER MATCH + OMT
Players undertook a recording session the day after a rugby match and received 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
|
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
|
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
|
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
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
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
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)
October 1, 2017
Primary Completion (ACTUAL)
May 1, 2018
Study Completion (ACTUAL)
May 1, 2018
Study Registration Dates
First Submitted
January 21, 2020
First Submitted That Met QC Criteria
January 22, 2020
First Posted (ACTUAL)
January 27, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 22, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Other Study ID 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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