MenopauseNCT07824947
Effects of Strength Training on the Gait and Pelvic Floor in Menopausal Women
A study testing Strength training in people with Menopause and Gait, Unsteady, run by University of Alcala at 1 site in Spain.
Trial summary
The overall objective will be to observe whether a strength and balance training intervention produces significant changes in the analysis of double stance phase movement during gait, the analysis of coxofemoral, tibial and calcaneal joint movement during gait, pelvic floor contractile activity in standing and… Read more about this study
- Who is it for?
- Ages 45 to 77 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Gait, Unsteady, Pelvic Floor Disorders
- What is being tested?
- Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2023to 1 Jan 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 45 to 77 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 45 to 76 years.
- Menopausal (minimum 12 months of amenorrhea).
- Sedentary lifestyle (less than 30 minutes per day of regular exercise and less than 3 days per week according to WHO definition).
- Availability to participate in the study and attend all scheduled sessions.
- Able to read, write, and command spoken and written Spanish language.
- Diagnosis of urinary incontinence, pelvic organ prolapse, and/or sexual dysfunction.
Who cannot join
- Systemic disease.
- Cardiovascular disease.
- Vestibular and/or visual pathology (including vertigo, tinnitus, hypoacusis, or aural tinnitus).
- History of psychiatric illness.
- Cognitive deficits for any reason.
- Neurological injury.
Show all 12Show fewer
- Use of walking aids, orthoses, or prostheses.
- Ingestion of vestibular sedatives or central nervous system depressants.
- Musculoskeletal diseases with lower limb deformity.
- Lower limb surgery within the last 10 years.
- Urogenital surgery.
- Latex allergy.
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective will be to observe whether a strength and balance training intervention produces significant changes in the analysis of double stance phase movement during gait, the analysis of coxofemoral, tibial and calcaneal joint movement during gait, pelvic floor contractile activity in standing and monopodal stability, stress urinary incontinence, fracture risk, sexual function and prolapse in sedentary menopausal women in the short and medium term.
Read the detailed description
A prospective experimental study will be conducted. A single-blind, randomised controlled clinical trial.
The study subjects will be selected voluntarily and will meet the inclusion criteria of the study. The sample will be recruited through social networks (Instagram, twitter, facebook), messaging applications (whatsapp, tiami, lex), public and private gynaecology consultations in different health centres and women's associations.
Women over 45 and under 77 years of age in the menopausal period (minimum 12 months of amenorrhoea) who have read the information sheet, completed the informed consent form and met the following inclusion criteria will participate in the study:
A prospective experimental study will be conducted. A single-blind, randomised controlled clinical trial.
The study subjects will be selected voluntarily and will meet the inclusion criteria of the study. The sample will be recruited through social networks (Instagram, twitter, facebook), messaging applications (whatsapp, tiami, lex), public and private gynaecology consultations in different health centres and women's associations.
Women over 45 and under 77 years of age in the menopausal period (minimum 12 months of amenorrhoea) who have read the information sheet, completed the informed consent form and met the following inclusion criteria will participate in the study:
Sedentary described as less than 30 minutes per day of regular exercise and less than 3 days per week as defined by the W.H.O. regular physical activity.
Availability to participate in the study and to attend all the scheduled sessions.
Be able to read and write and be fluent in spoken and written Spanish. Have a diagnosis of urinary incontinence and/or pelvic organ prolapse and/or sexual dysfunction.
Exclusion criteria:
Systemic disease Cardiovascular disease Vestibular and/or visual pathology including clinical symptoms of vertigo, tinnitus, hypoacusis and/or aural plentitude History of psychiatric illness Cognitive deficits for any reason Neurological injury Walking aids, orthoses or prostheses Ingestion of vestibular sedatives or other central nervous system depressants Musculoskeletal diseases with lower limb deformity Lower limb surgery within the last 10 years Urogenital surgery Latex allergy
Interested subjects who have received the contact request will contact the PI by email and fill in the online citation questionnaire, the purpose of this questionnaire will be to exclude subjects with any exclusion criteria. Provided they meet the inclusion criteria, the selected subjects will be sent the information form for the subjects and visits will be scheduled at the research laboratory of the European University, where the data of the variables will be recorded by a physiotherapist specialised in pelviperineology and with experience in the use of the required apparatus, in this case, the, PI who will be blinded to the assignment groups where he/she will measure: pelvic floor, gait analysis and the described questionnaires (IFSF, EPIQ, FRAX, ICIQ) that the patients will fill in themselves on a tablet device that we will have in the laboratory. The PI will verify that they meet the inclusion criteria, that they have read and understand the HIP and the informed consent. All measurements will be performed on the same day. At the end of the assessment by the PI, they will be contacted by researcher 1 who will randomly assign participants to the intervention or control group. This 1:1 randomisation is performed by investigator 1 using validated OxMaR software.
Participants in the intervention group will be scheduled two days a week for two guided sessions of live training and online exercises supervised and guided by a physiotherapist trained in therapeutic exercise. In the case of the intervention group, two 60-minute sessions will be carried out every week for three months. The control group will not carry out any training sessions, only the same assessments as the intervention group.
All participants will undergo a total of 3 assessments and the intervention group a total of 24 live training sessions.
The adherence of the participants will be recorded in an activity forum in which they will be instructed at the time they enter the study.
- Conditions
- Menopause, Gait, Unsteady, Pelvic Floor Disorders
- Being tested
- Strength training
- Keywords
- prolapse, urinary incontinence, gait disturbance, gait analysis, sexual satisfaction, risk of fracture
- Medical subject headings
- Gait Disorders, Neurologic, Pelvic Floor Disorders, Prolapse, Urinary Incontinence, Mobility Limitation, Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingOther
Two 45-60 minute sessions per week for 12 weeks of live online training supervised by a qualified exercise specialist/physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (Strength Training first) | Experimental | Participants will receive the strength training intervention (two 45-60 minute live online supervised sessions per week for 12 weeks) followed by a control/washout period. Receives: Other: Strength training |
| Sequence B (Control first) | Experimental | Participants will first complete a control period (no training sessions) for 12 weeks, followed by the strength training intervention. Receives: Other: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Muscle Activity During Gait
Mean root mean square (RMS) amplitude of the EMG signal of pelvic floor muscles recorded during 90 seconds of steady-state walking at self-selected speed using intracavitary electromyography (Mdurance®). Signals will be band-pass filtered (10-480 Hz), rectified, and processed using RMS.
Measured: Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)
Secondary outcomes (2)
Gait Kinematics
Kinematic parameters during steady-state walking at self-selected speed assessed using the OptiTrack® motion capture system. Mean values will be calculated from selected cycles with the lowest variability.
Measured: Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)
Plantar Pressure Distribution
Plantar pressure distribution during steady-state walking at self-selected speed assessed using the Tekscan® system. Mean values will be calculated from selected cycles with the lowest variability.
Measured: Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Apr 2023
- Primary completion31 Jul 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Cerezo-Téllez, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824947
- Sponsor's protocol ID
- OE 21/2022
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strength Training on the Gait and Pelvic Floor in Menopausal Women
- ClinicalTrials.gov ID
- NCT07824947
- Acronym / sponsor ID
- OE 21/2022
- Conditions
- Menopause, Gait, Unsteady, Pelvic Floor Disorders
- Keywords
- prolapse, urinary incontinence, gait disturbance, gait analysis, sexual satisfaction, risk of fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 17 Sep 2026 (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.
The overall objective will be to observe whether a strength and balance training intervention produces significant changes in the analysis of double stance phase movement during gait, the analysis of coxofemoral, tibial and calcaneal joint movement during gait, pelvic floor contractile activity in standing and monopodal stability, stress urinary incontinence, fracture risk, sexual function and prolapse in sedentary menopausal women in the short and medium term.
Detailed description
A prospective experimental study will be conducted. A single-blind, randomised controlled clinical trial.
The study subjects will be selected voluntarily and will meet the inclusion criteria of the study. The sample will be recruited through social networks (Instagram, twitter, facebook), messaging applications (whatsapp, tiami, lex), public and private gynaecology consultations in different health centres and women's associations.
Women over 45 and under 77 years of age in the menopausal period (minimum 12 months of amenorrhoea) who have read the information sheet, completed the informed consent form and met the following inclusion criteria will participate in the study:
A prospective experimental study will be conducted. A single-blind, randomised controlled clinical trial.
The study subjects will be selected voluntarily and will meet the inclusion criteria of the study. The sample will be recruited through social networks (Instagram, twitter, facebook), messaging applications (whatsapp, tiami, lex), public and private gynaecology consultations in different health centres and women's associations.
Women over 45 and under 77 years of age in the menopausal period (minimum 12 months of amenorrhoea) who have read the information sheet, completed the informed consent form and met the following inclusion criteria will participate in the study:
Sedentary described as less than 30 minutes per day of regular exercise and less than 3 days per week as defined by the W.H.O. regular physical activity.
Availability to participate in the study and to attend all the scheduled sessions.
Be able to read and write and be fluent in spoken and written Spanish. Have a diagnosis of urinary incontinence and/or pelvic organ prolapse and/or sexual dysfunction.
Exclusion criteria:
Systemic disease Cardiovascular disease Vestibular and/or visual pathology including clinical symptoms of vertigo, tinnitus, hypoacusis and/or aural plentitude History of psychiatric illness Cognitive deficits for any reason Neurological injury Walking aids, orthoses or prostheses Ingestion of vestibular sedatives or other central nervous system depressants Musculoskeletal diseases with lower limb deformity Lower limb surgery within the last 10 years Urogenital surgery Latex allergy
Interested subjects who have received the contact request will contact the PI by email and fill in the online citation questionnaire, the purpose of this questionnaire will be to exclude subjects with any exclusion criteria. Provided they meet the inclusion criteria, the selected subjects will be sent the information form for the subjects and visits will be scheduled at the research laboratory of the European University, where the data of the variables will be recorded by a physiotherapist specialised in pelviperineology and with experience in the use of the required apparatus, in this case, the, PI who will be blinded to the assignment groups where he/she will measure: pelvic floor, gait analysis and the described questionnaires (IFSF, EPIQ, FRAX, ICIQ) that the patients will fill in themselves on a tablet device that we will have in the laboratory. The PI will verify that they meet the inclusion criteria, that they have read and understand the HIP and the informed consent. All measurements will be performed on the same day. At the end of the assessment by the PI, they will be contacted by researcher 1 who will randomly assign participants to the intervention or control group. This 1:1 randomisation is performed by investigator 1 using validated OxMaR software.
Participants in the intervention group will be scheduled two days a week for two guided sessions of live training and online exercises supervised and guided by a physiotherapist trained in therapeutic exercise. In the case of the intervention group, two 60-minute sessions will be carried out every week for three months. The control group will not carry out any training sessions, only the same assessments as the intervention group.
All participants will undergo a total of 3 assessments and the intervention group a total of 24 live training sessions.
The adherence of the participants will be recorded in an activity forum in which they will be instructed at the time they enter the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A (Strength Training first) | Experimental | Other: Strength trainingParticipants will receive the strength training intervention (two 45-60 minute live online supervised sessions per week for 12 weeks) followed by a control/washout period. |
| Sequence B (Control first) | Experimental | Other: Strength trainingParticipants will first complete a control period (no training sessions) for 12 weeks, followed by the strength training intervention. |
Who may qualify
- Ages
- 45 to 77 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 45 to 76 years.
- Menopausal (minimum 12 months of amenorrhea).
- Sedentary lifestyle (less than 30 minutes per day of regular exercise and less than 3 days per week according to WHO definition).
- Availability to participate in the study and attend all scheduled sessions.
- Able to read, write, and command spoken and written Spanish language.
Key exclusion criteria (12 listed)
- Systemic disease.
- Cardiovascular disease.
- Vestibular and/or visual pathology (including vertigo, tinnitus, hypoacusis, or aural tinnitus).
- History of psychiatric illness.
- Cognitive deficits for any reason.
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 |
|---|---|---|
| Strength trainingTwo 45-60 minute sessions per week for 12 weeks of live online training supervised by a qualified exercise specialist/physiotherapist. | Other | Sequence A (Strength Training first), Sequence B (Control first) |
Primary outcome
Pelvic Floor Muscle Activity During Gait
Time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)
Mean root mean square (RMS) amplitude of the EMG signal of pelvic floor muscles recorded during 90 seconds of steady-state walking at self-selected speed using intracavitary electromyography (Mdurance®). Signals will be band-pass filtered (10-480 Hz), rectified, and processed using RMS.
2 secondary outcomes
Gait Kinematics
Time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)
Plantar Pressure Distribution
Time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)
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 21 Sep 2026.
- 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 Strength training in people with Menopause and Gait, Unsteady, run by University of Alcala 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 6 inclusion and 12 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 21 Sep 2026. 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?
Pelvic Floor Muscle Activity During Gait (time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)). 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 21 Sep 2026.