NCT06323941

Brief Summary

Mental practice (both in isolation and also in combination with real practice) has been shown to improve somatosensory and motor variables but so far no study has taken it into the study of women's health. Through the present study the investigators want to offer some interesting data regarding the effectiveness of mental practice combined with physical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

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

November 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

March 14, 2024

Last Update Submit

March 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Skin conductance (for asessing electrodermal activity)

    skin conductance is a measure of sweating which is an excitatory sympathetic monoinervative variable.

    pre-intervention (T0), and inmmediate post-intervention (T1) (between the first and the second measurement, about 60 minutes have elapsed because it is done on the same day)

Secondary Outcomes (2)

  • Algometry for assessing pressure pain thresholds (Pain sensitivity)

    pre-intervention (T0), and inmmediate post-intervention (T1) (between the first and the second measurement, about 60 minutes have elapsed because it is done on the same day)

  • maximal pelvic floor muscle strength (measured in grams and with the phenix device)

    pre-intervention (T0), and inmmediate post-intervention (T1) (between the first and the second measurement, about 60 minutes have elapsed because it is done on the same day)

Study Arms (2)

Motor Imagery plus Isometric Exercise

EXPERIMENTAL

This group will perform a therapeutic exercise programme (isometric exercises training) to which motor imagery training will be added.

Behavioral: Motor Imagery plus therapeutic exercise

Isometric Exercise

ACTIVE COMPARATOR

This group will perform a therapeutic exercise programme (isometric exercises training) to which sham motor imagery training will be added.

Behavioral: Therapeutic exercises

Interventions

Isometric exercises (20 minutes) to which will be added a motor imagery intervention (imagining movements without actually doing them).

Motor Imagery plus Isometric Exercise

Isometric exercises (20 minutes) to which will be added a placebo motor imagery intervention (imagining a blue sky).

Isometric Exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Over 18 years of age and asymptomatic women.

You may not qualify if:

  • This study will exclude those who presented a respiratory pathology, cardiac, systematic, or metabolic disease, history of recent surgery, vertebral fracture, or osteoarticular disorders of the spine area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferran Cuenca Martínez

Valencia, 46017, Spain

Location

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 14, 2024

First Posted

March 21, 2024

Study Start

November 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 14, 2024

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations