Isometric ExerciseNCT06323941
Motor Imagery and Isometric Exercises on Pelvic Floor Sensorimotor Condition
A study testing Motor Imagery plus therapeutic exercise and Therapeutic exercises in people with Isometric Exercise and Motor Imagery, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Isometric Exercise, Motor Imagery, Women's Health
- What is being tested?
- Motor Imagery plus therapeutic exercise and Therapeutic exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 14 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over 18 years of age and asymptomatic women.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Motor Imagery on Skin Conductance and Pelvic Floor Sensorimotor Condition in Healthy Women: A Randomized Controlled Trial
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.
- Conditions
- Isometric Exercise, Motor Imagery, Women's Health
- Being tested
- Motor Imagery plus therapeutic exercise, Therapeutic exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Imagery plus therapeutic exerciseBehavioural
Isometric exercises (20 minutes) to which will be added a motor imagery intervention (imagining movements without actually doing them).
Therapeutic exercisesBehavioural
Isometric exercises (20 minutes) to which will be added a placebo motor imagery intervention (imagining a blue sky).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Therapeutic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin conductance (for asessing electrodermal activity)
skin conductance is a measure of sweating which is an excitatory sympathetic monoinervative variable.
Measured: 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)
An algometer shall be used to assess pain thresholds to pressure, i.e. squeezing so that pressure is converted into pain at two points. One point in the symphysis pubis area, and one point near the tibial tuberosity
Measured: 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)
Three measurements of maximal pelvic floor strength shall be performed with an intracavitary probe and the mean of the three measurements of maximal pelvic floor muscle strength shall be considered.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Nov 2023
- Primary completion1 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isometric ExerciseStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferran Cuenca, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323941
- Sponsor's protocol ID
- UV0003
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Imagery on Skin Conductance and Pelvic Floor Sensorimotor Condition in Healthy Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06323941
- Acronym / sponsor ID
- UV0003
- Conditions
- Isometric Exercise, Motor Imagery, Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery plus Isometric Exercise | Experimental | Behavioral: Motor Imagery plus therapeutic exerciseThis group will perform a therapeutic exercise programme (isometric exercises training) to which motor imagery training will be added. |
| Isometric Exercise | Active comparator | Behavioral: Therapeutic exercisesThis group will perform a therapeutic exercise programme (isometric exercises training) to which sham motor imagery training will be added. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Over 18 years of age and asymptomatic women.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor Imagery plus therapeutic exerciseIsometric exercises (20 minutes) to which will be added a motor imagery intervention (imagining movements without actually doing them). | Behavioural | Motor Imagery plus Isometric Exercise |
| Therapeutic exercisesIsometric exercises (20 minutes) to which will be added a placebo motor imagery intervention (imagining a blue sky). | Behavioural | Isometric Exercise |
Primary outcome
Skin conductance (for asessing electrodermal activity)
Time frame: 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)
skin conductance is a measure of sweating which is an excitatory sympathetic monoinervative variable.
2 secondary outcomes
Algometry for assessing pressure pain thresholds (Pain sensitivity)
Time frame: 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)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery plus therapeutic exercise and Therapeutic exercises in people with Isometric Exercise and Motor Imagery, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin conductance (for asessing electrodermal activity) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.