Gait, Unsteady, Menopause, Pelvic Floor Disorders
Conditions
Keywords
prolapse, urinary incontinence, gait disturbance, gait analysis, sexual satisfaction, risk of fracture
Brief 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 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.
Interventions
OTHERStrength training
A intervention group participants will be scheduled two days a week for two guided live training sessions and online exercises. supervised and guided by a physiotherapist trained in therapeutic exercise. In short, two 60-minute sessions will be carried out every week for three months in the case of the intervention group. The control group will not carry out any training sessions, only the same assessments as the intervention group. All participants will carry out a total of 3 assessments and the intervention group a total of 24 live training sessions.
Sponsors
University of Alcala
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Masking description
At the end of the PI's assessment, they will be contacted by researcher 1 who will randomly assign participants to either the intervention or control group.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 77 Years
Healthy volunteers
Yes
Inclusion criteria
Women over 45 years of age and under 77 years of age in menopausal period (minimum 12 months of amenorrhea) who have read the information sheet, completed the informed consent and meet the following inclusion criteria will participate in the study: Sedentary lifestyle described as less than 30 minutes per day of regular exercise and less than 3 days per week according to the WHO definition of regular physical activity. Availability to participate in the study and to attend all the scheduled sessions. Be able to read and write and have a command of the spoken and written Spanish language. 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 tinnitus 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Muscle Activity During Gait | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Kinematics | Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention) | 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. |
| Plantar Pressure Distribution | Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention) | 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. |
Countries
Spain
Outcome results
None listed