Healthy Subject, Heart Rate Variability
Conditions
Brief summary
The aim of the present study is to determine the extend to which osteopathic manipulative treatment (OMT) is effective on a sample of healthy subjects in changing high frequency (HF) parameters.
Interventions
OTHEROsteopathic manipulative treatment
OTHERSHAM
OTHERCONTROL
Sponsors
European Institute for Evidence Based Osteopathic Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 45; * No chronic symptomatology; * No acute symptomatology during the last 72 hours before intervention; * No pathologies
Exclusion criteria
* Age below 18 or over 45; * Pregnancy; * Menopause; * Abuse of alcool during the last 48 hours; * Chronic pain; * Acute pain during the last 72 hours; * Conclamate pathologies; * Use of drugs during the last 72 hours ; * Use of ortothic devices during the last 3 months; * Any type of surgery; * Osteopathic treatment during the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline high frequency (HF) value at 1 week | baseline and 1 week |
Secondary
| Measure | Time frame |
|---|---|
| Change in VLF value | during treatment session |
| Change in SDNN value | during treatment session |
| Change in RMSSD value | during treatment session |
| Change in pNN50 value | during treatment session |
| Change in DFAa1 value | during treatment session |
| Change from baseline intrasubject HF value at 1 week | baseline and 1 week |
| Change from baseline standard deviation beat-to-beat (SDNN) value at 1 week | baseline and 1 week |
| Changes from baseline square root of the mean squared difference of successive beat-to-beat (RMSSD) at 1 week | baseline and 1 week |
| Change in LF/HF ratio value | during treatment session |
| Change in LF value | during treatment session |
| Change from baseline proportion of beat-to-beat50 divided by total number of beat-to-beats in (pNN50) at 1 week | baseline and 1 week |
| Change from baseline in low frequency (LF) value at 1 week | baseline and 1 week |
| Change from baseline LF/HF ratio value at 1 week | baseline and 1 week |
| Change from baseline very low frequency (VLF) value at 1 week | baseline and 1 week |
| Change from baseline heart rate variability parameters between smokers and no-smokers at 1 week | baseline and 1 week |
| Change from baseline 15D questionnaire at 1 week | baseline and 1 week |
| Differences in skin conductance value between groups | 1 week |
| Change from baseline detrended fluctuation scaling exponent (DFAa1) value at 1 week | baseline and 1 week |
Countries
Italy
Outcome results
None listed