NCT04242485

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

January 21, 2020

Last Update Submit

January 22, 2020

Conditions

Keywords

heart rateheart rate variabilityblood pressurerugby matchatlethesrecoveryosteopathy

Outcome Measures

Primary Outcomes (8)

  • Resting heart rate

    Mean heart rate measured as beats per minute

    ECG recorded for 10 min just before osteopathic manipulative treatment and sham treatment

  • Resting heart rate

    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)

    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)

    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)

    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)

    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

    Mean arterial pressure measured in mmHg

    Assessed just before osteopathic manipulative treatment and sham treatment with a sphygmomanometer

  • Resting mean arterial pressure

    Mean arterial pressure measured in mmHg

    Assessed just after osteopathic manipulative treatment and sham treatment with a sphygmomanometer

Secondary Outcomes (3)

  • Heart rate reactivity to orthostasis

    ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)

  • Heart rate variability (RMSSD index) reactivity to orthostasis

    ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)

  • Heart rate variability (HF index) reactivity to orthostasis

    ECG recorded for 10 min during orthostasis (5 min) and subsequent recovery (5 min)

Study Arms (4)

AFTER MATCH + OMT

OTHER

Players undertook a recording session the day after a rugby match and received osteopathic manipulative treatment

Other: Osteopathic manipulative treatment

AFTER MATCH + sham treatment

OTHER

Players undertook a recording session the day after a rugby match and received sham treatment

Other: Sham treatment

NO MATCH + OMT

OTHER

Players undertook a recording session the day after a resting day and received osteopathic manipulative treatment

Other: Osteopathic manipulative treatment

NO MATCH + sham treatment

OTHER

Players undertook a recording session the day after a resting day and received sham treatment

Other: Sham treatment

Interventions

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

AFTER MATCH + OMTNO MATCH + OMT

The sham treatment consisted only in "soft touch" of the same body areas involved in the osteopathic manipulative treatment protocol without applying any pressure

AFTER MATCH + sham treatmentNO MATCH + sham treatment

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Collegio Italiano di Osteopatia

Parma, Italy

Location

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
full professor

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 27, 2020

Study Start

October 1, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations