NCT05787626

Brief Summary

In the present study, 28 healthy young people will be selected, who will be evaluated by a blind investigator regarding the study objectives, and will be randomly included in two groups. The experimental group will consist of 14 subjects who will carry out 1 weekly session of 10 minutes and who will be evaluated just before starting the intervention, after it and at 4 weeks. The control group will be made up of 14 subjects who will be evaluated in the three periods described without the need to carry out the intervention.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable healthy

Status
unknown

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

First Submitted

Initial submission to the registry

March 3, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

March 3, 2023

Last Update Submit

March 14, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Centimetric measurement of the thorax

    measuring the difference in circumference after maximum inhalation through the nose and maximum exhalation through the mouth, the measurement is made at the level of the xiphoid process

    change from baseline to one month

  • Back range of motion

    Performing the Ott Test, which consists of performing, with the subject standing, two measurements, one in the lower part of the spinous process of C7 and the other 30 centimeters below the previous mark.

    change from baseline to one month

  • Inspiratory and expiratory capacity

    will be carried out using an incentive spirometer

    change from baseline to one month

Study Arms (2)

Interventional group

EXPERIMENTAL

The intervention consists of the application of a myofascial technique in the diaphragmatic region, one hand of the therapist will be placed on the hemidiaphragm to be treated and the other hand on the same side but on the dorsal part of the patient on the costal edge of the last ribs.

Other: manipulation

Control group

SHAM COMPARATOR

In the subjects of the control group, the hands will be placed in the same position but without any therapeutic intention, applying the minimum possible pressure.

Other: manipulation

Interventions

miofascial technique in diaphragmatic region

Control groupInterventional group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy people
  • no spinal pathology
  • no respiratory pathology

You may not qualify if:

  • have suffered spinal pathologies in the last 3 months
  • have suffered respiratory diseases in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 28, 2023

Study Start

April 1, 2023

Primary Completion

May 1, 2023

Study Completion

May 30, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03