Effects of Strength Training on the Gait and Pelvic Floor in Menopausal Women

NCT07824947 | Completed

• 1 other identifier: OE 21/2022
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Pelvic Floor Disorders; Gait, Unsteady

Keywords

prolapse; urinary incontinence; gait disturbance; gait analysis; sexual satisfaction; risk of fracture

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)

Secondary Outcomes (2)

• Gait Kinematics

  Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)

• Plantar Pressure Distribution

  Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)

Study Arms (2)

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.

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.

Other: Strength training

Interventions

Strength training OTHER

Two 45-60 minute sessions per week for 12 weeks of live online training supervised by a qualified exercise specialist/physiotherapist.

Sequence A (Strength Training first); Sequence B (Control first)

Eligibility Criteria

• Age: 45 Years - 77 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Universidad Europea de Madrid

Madrid, Villaviciosa de ODON, 28670, Spain

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic; Pelvic Floor Disorders; Prolapse; Urinary Incontinence; Mobility Limitation; Orgasm

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: September 17, 2026
• Study Start: April 1, 2023
• Primary Completion: July 31, 2023
• Study Completion: January 1, 2024
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

ES (1)