Mental Practice and Therapeutic Exercise in Young Nulliparous Women

Sponsor

University of Valencia (Other)

Overall Status

Recruiting

CT.gov ID

NCT06073210

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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 this study we want to offer some interesting data regarding the effectiveness of mental practice combined with physical practice.

Condition or Disease	Intervention/Treatment	Phase
Therapeutic Exercise Motor Imagery Action Observation	Behavioral: Motor Imagery plus therapeutic exercise Behavioral: Action observation plus therapeutic exercise Behavioral: Sham action observation plus therapeutic exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Mental Practice and Therapeutic Exercise in Young Nulliparous Women: A Randomized Controlled Trial

Anticipated Study Start Date :

Sep 30, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Therapeutic exercise plus motor imagery This group will perform a therapeutic exercise programme (aerobic and strength training) to which motor imagery training will be added.	Behavioral: Motor Imagery plus therapeutic exercise Aerobic exercise (20 minutes) and strengthening exercise (15 minutes) to which will be added a motor imagery intervention (imagining movements without actually doing them).
Experimental: Therapeutic exercise plus action observation This group will perform a therapeutic exercise programme (aerobic and strength training) to which action observation training will be added.	Behavioral: Action observation plus therapeutic exercise Aerobic exercise (20 minutes) and strengthening exercise (15 minutes) to which will be added a action observation intervention (observing movements without actually doing them).
Active Comparator: Therapeutic exercise This group will perform a therapeutic exercise programme (aerobic and strength training) to which sham action observation training will be added.	Behavioral: Sham action observation plus therapeutic exercise Aerobic exercise (20 minutes) and strengthening exercise (15 minutes) to which will be added a sham action observation intervention (observing space planets).

Arm

Intervention/Treatment

Experimental: Therapeutic exercise plus motor imagery

This group will perform a therapeutic exercise programme (aerobic and strength training) to which motor imagery training will be added.

Behavioral: Motor Imagery plus therapeutic exercise

Aerobic exercise (20 minutes) and strengthening exercise (15 minutes) to which will be added a motor imagery intervention (imagining movements without actually doing them).

Experimental: Therapeutic exercise plus action observation

This group will perform a therapeutic exercise programme (aerobic and strength training) to which action observation training will be added.

Behavioral: Action observation plus therapeutic exercise

Aerobic exercise (20 minutes) and strengthening exercise (15 minutes) to which will be added a action observation intervention (observing movements without actually doing them).

Active Comparator: Therapeutic exercise

This group will perform a therapeutic exercise programme (aerobic and strength training) to which sham action observation training will be added.

Behavioral: Sham action observation plus therapeutic exercise

Aerobic exercise (20 minutes) and strengthening exercise (15 minutes) to which will be added a sham action observation intervention (observing space planets).

Outcome Measures

Primary Outcome Measures

Pelvic Floor Muscle Strength [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).]
maximum pelvic floor strength
Pain Pressure Threshold [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).]
Pain sensitivity
Lumbopelvic Motor Control [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).]
Sensorimotor control of lower limbs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

over 18 years of age and asymptomatic women.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ferran Cuenca Martínez	Valencia		Spain	46017

Sponsors and Collaborators

University of Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ferran Cuenca, PhD, University of Valencia

ClinicalTrials.gov Identifier:

NCT06073210

Other Study ID Numbers:

UV0001

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 10, 2023