Effects of Hypopressive Abdominal Gymnastics in Urinary Incontinence

NCT05722821 | Completed

• 1 other identifier: - University of Jaén.
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The increase in the age of the population is a problem that affects both Spain and the rest of the world. Life expectancy increases, and this will influence the quality of life that older people will have. The quality of life is related to the health of the population. Women live longer than men and have diseases such as urinary incontinence that are more frequent in them. This is related to childbirth, increasing age, and menopause due to the hormonal level. Therefore, there are a series of problems related to both physical and mental health associated both with increasing age and with the situation of hormonal change that occurs after the onset of menopause. All of this will influence deficient pelvic musculature, sexual function, sleep quality, and depression/anxiety. Conservative treatment using hypopressive abdominal exercises has been shown to be beneficial at the level of health in female populations with urinary incontinence. The challenge lies in designing exercise programs that, in addition to achieving these benefits, are attractive with acceptance and adherence. The objective of this doctoral thesis is to study the effects of hypopressive abdominal exercises for 12 weeks on quality of life related to urinary incontinence in women, sleep quality, anxiety and depression, and female sexual function in women. Spanish postmenopausal women.

Conditions

Menopause; Older Adults

Outcome Measures

Primary Outcomes (8)

• International Consulation on Incontinence Short Quality of Life Questionnaire

  Is a brief questionnaire aimed at measuring the perception of UI symptoms and the patient's quality of life. The scores of the questions 1+2+3 are added. Any score greater than zero is considered a diagnosis of UI.

  Up to twelve weeks

• PSQI (Pittsburgh Sleep Quality Index)

  A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result. Higher scores indicate poorer sleep.

  Up to twelve weeks

• Pelvic organ prolapse/urinary incontinence sexual function questionnaire-12

  It is an instrument with adequate psychometric characteristics to assess sexual function in women with pelvic floor problems in Spain. The score is made by adding the scores of each item, (from 0=always to 4=never), inverting this score for items 1, 2, 3, and 4.

  Up to twelve weeks

• Prolapse quality of life questionnaire

  The P-QoL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health (1 item), prolapse impact (1 item), role limitations (2 items), physical limitations (2 items), social limitations (3 items), personal relationships (2 items), emotions (3 items), sleep/energy (2 items) and severity measures (4 items). Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life. Additionally, there are 18 questions regarding urinary, bowel, and prolapse/vaginal symptoms, which do not have an assigned score. Response options are on a Likert scale with ranges between 1 and 4, except for the first question, that ranges between 1 and 5. Symptoms questions and personal relationships domains offer the option Not applicable.

  Up to twelve weeks

• Handgrip Strength

  Dynamometer will be employed to assess hand grip strength.

  Up to twelve weeks

• TUG test (Timed Up and Go test)

  Is a simple test used to assess a person's mobility and physical function.

  Up to twelve weeks

• Chair sit and reach test.

  To test low back and hamstring flexibility.

  Up to twelve weeks

• Back scratch test.

  To measure general shoulder range of motion.

  Up to twelve weeks

Secondary Outcomes (4)

• BMI (Body Mass Index)

  Up to twelve weeks

• Waist circumference.

  Up to twelve weeks

• Hip circumference

  Up to twelve weeks

• Waist-to-hip ratio.

  Up to twelve weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

An experimental group (GE): that after an initial evaluation will be subjected to a hypopressive abdominal gymnastics program, for 12 weeks with 2 weekly sessions (Tuesday and Thursday, controlling adherence to the sessions through attendance), with a duration of 45 min per session. Once the intervention is finished, you will be subjected to a final evaluation to see if there is a difference or not with the results obtained at the beginning.

Other: Hypopressive intervention

Control group

NO INTERVENTION

A control group (CG): that will not be subjected to treatment, which will be evaluated in the pre and post phase of the study, and a follow-up by telephone contact of adherence to physical activity. The participants assigned to this group will receive general advice on the positive effects of the regular practice of physical activity aimed at preventing urinary incontinence, and they will be given the guide of recommendations for the promotion of physical activity.

Interventions

Hypopressive intervention OTHER

Hypopressive abdominal gymnastics is based on a basic level hypopressive exercise program that will be: * A duration of 12 weeks with a frequency of 2 sessions a week and lasting 45 minutes each. Hypopressive abdominal exercises will be performed individually adapted to the capacity of the participant. * There will be an initial anatomical training of the muscles involved in carrying out the exercise and practice in the respiratory technique for a duration of 15 minutes. Afterwards, hypopressive exercises will begin for 20-30 minutes, changing positions if possible.

Experimental group

Eligibility Criteria

• Age: 65 Years+
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Women with urinary incontinence with cessation of menstrual activity for 12 months or more and who are able to understand the instructions and exercise protocols of this project.

You may not qualify if:

• Contraindications for physical tests, cancer or serious illness, musculoskeletal and neurological diseases (Parkinson's disease, multiple sclerosis, diabetic neuropathy, cerebrovascular accident, etc.).
• Taking drugs that affect the central nervous system or antidepressants, or lack of willingness to participate in the study.
• People who have previously carried out pelvic floor reeducation programs.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Center for the Elderly "Gallur"

Zaragoza, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For the assignment to the groups, a random sampling will be carried out using the Epidat program. This classification will be hidden, therefore, those responsible for admitting the patients to the intervention phase will not know to which group each one has been assigned. Said assignment will be made previously by a researcher who will not intervene in the subsequent phases of evaluation, data recording intervention and database preparation. The assignment will be communicated using fully opaque sealed envelopes. The analysis of the results will be carried out by a researcher unrelated to the group assignment and the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: March 13, 2023
• Primary Completion: June 2, 2023
• Study Completion: June 12, 2023
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

ES (1)