NCT04343599

Brief Summary

Effects of an exercise program based on hypopressive exercises in the female population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 9, 2020

Last Update Submit

April 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postural control

    Postural control was evaluated by means of a stabilometric platform of resistive pressure sensors (Sensor Medica, Rome, Italy).

    From baseline to 10 weeks.

Secondary Outcomes (5)

  • Pelvic floor muscles strength

    From baseline to 10 weeks.

  • Self-reported pelvic floor status

    From baseline to 10 weeks

  • Urinary incontinence

    From baseline to 10 weeks

  • Transversus abdominis activation

    From baseline to 10 weeks.

  • Pulmonary ventilation

    From baseline to 10 weeks

Study Arms (2)

Hypopressive exercises

EXPERIMENTAL

Patients completed 10 weeks of abdominal hypopressive exercises with two sessions of 30 minutes per week.

Other: Hypopressive exercises

Control group

NO INTERVENTION

Patients allocated to the control group did not receive any treatment.

Interventions

The first two sessions will have as objective the correct and effective learning of the hypopressive technique. The rest of the sessions will be dedicated to the realization of an exercise protocol based on a progression of postures from standing to supine. Diaphragmatic apneas of approximately 7 seconds will be performed, alternating each apnea with three breaths.

Hypopressive exercises

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • Physical autonomy

You may not qualify if:

  • Vestibular disorders.
  • Coronary diseases.
  • Recent surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jaen

Jaén, 23071, Spain

Location

MeSH Terms

Conditions

Pelvic Floor DisordersMuscle Weakness

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • David Cruz-Díaz

    University of Jaén

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
An independent assessor blinded to the data collection was responsible for the allocation process. A list of the computer-generated number was employed to assign participants to experimental or control group
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study was a single-blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 13, 2020

Study Start

March 1, 2019

Primary Completion

June 7, 2019

Study Completion

June 12, 2019

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Provided by reasonable request.

Locations