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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04242485
Other study ID # 032017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date May 1, 2018

Study information

Verified date January 2020
Source University of Parma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date May 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Cardiovascular Physiological Phenomena

Intervention

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
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

Locations

Country Name City State
Italy Collegio Italiano di Osteopatia Parma

Sponsors (3)

Lead Sponsor Collaborator
University of Parma Collegio Italiano di Osteopatia, Foundation COME Collaboration

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resting heart rate Mean heart rate measured as beats per minute ECG recorded for 10 min just before osteopathic manipulative treatment and sham treatment
Primary Resting heart rate Mean heart rate measured as beats per minute ECG recorded for 5 min just after osteopathic manipulative treatment and sham treatment
Primary Resting heart rate variability (RMSSD index) 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
Primary Resting heart rate variability (RMSSD index) 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
Primary Resting heart rate variability (HF index) 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
Primary Resting heart rate variability (HF index) 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
Primary Resting mean arterial pressure Mean arterial pressure measured in mmHg Assessed just before osteopathic manipulative treatment and sham treatment with a sphygmomanometer
Primary Resting mean arterial pressure Mean arterial pressure measured in mmHg Assessed just after osteopathic manipulative treatment and sham treatment with a sphygmomanometer
Secondary Heart rate reactivity to orthostasis Mean heart rate measured as beats per minute ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)
Secondary Heart rate variability (RMSSD index) reactivity to orthostasis 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)
Secondary Heart rate variability (HF index) reactivity to orthostasis 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)
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