An interventional study of Strength training in Menopause, Gait, Unsteady and Pelvic Floor Disorders, sponsored by University of Alcala. Completed at 1 site in Spain. Open to female participants aged 45 Years to 77 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of Alcala · Not applicable, Interventional, and Prevention
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.
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.
346 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.
This study's enrollment of 34 is above the median of 30 across 261 interventional studies indexed under Gait Disorders, Neurologic.
Browse Gait Disorders, Neurologic studies →University of Alcala is the lead sponsor of 128 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
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.
Other: Strength training
Participants will first complete a control period (no training sessions) for 12 weeks, followed by the strength training intervention.
Other: Strength training
Two 45-60 minute sessions per week for 12 weeks of live online training supervised by a qualified exercise specialist/physiotherapist.
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.
Time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)
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.
Time frame: 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.
Time frame: Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)
Plan to share: Undecided
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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