Multimodal Program for Climacteric Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-85
SponsorUniversity of Valencia

About this trial

Your study seems to aim at emphasizing the significance of non-pharmacological and non-hormonal approaches in managing menopausal symptoms, particularly focusing on muscle training and education. This holistic approach acknowledges the importance of physical well-being, psychological support, and education to enhance women's quality of life during the menopausal transition.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women aged ≥45 years

Women in climacteric period

Disqualifiers

Musculoskeletal, cognitive, infectious, neurological, or cardiorespiratory pathology impairing assessment or program completion.

Surgical intervention in lumbopelvic or gynecological region within the last 6 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • multimodal physiotherapy programme

    Other intervention

    The intervention to which the climacteric women will be subjected will consist of a combined program of education and general strength and pelvic floor muscles exercises of 8 weeks duration, at a rate of 2 sessions/week. Each of the sessions will last 60 min, except for the first one, which will be 90 min.

Treatment groups

115 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Upper limb muscle strength

For performed the upper limb muscle strength (kg) evaluation will use different dynamometry test Dynamometry of Upper limb muscle: using the Hand grip strength (stable position - elbow 90º and arm in contact with the trunk , hold dynamometer with the hand and perform maximum grip force for 5seconds.

Time frame
8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
2

Lower limb muscle strength

The quadriceps dynamometry test (Lafayette Instrument) will be used to evaluate the muscular strength of the lower extremities, the unit of measure will be. The Lafayette measuring range is 0-300 lbs (136.1 kg/1335 N).

Time frame
8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
3

Trunk flexor isometric strength

For the isometric strength of the trunk flexors, the central dynamometry test (Lafayette Instrument) will be used: the patient will be in the supine position with the knees straight, the hips flexed at 30° and the trunk at 30°; placing the dynamometer on the sternum, below the suprasternal notch, the participants should place their hands on the opposite acromion processes.The Lafayette measuring range is 0-300 lbs (136.1 kg/1335 N).

Time frame
8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)
4

Abdominopelvic muscle function

The Supine Bridge Test involves lying on a mat with knees and hips flexed, lifting the pelvis off the floor for alignment. The Prone Bridge requires lying face down on elbows, lifting the pelvis so only forearms and toes touch the floor. In the Side Bridge, one lies on their side, supporting the body with elbow, forearm, and feet while lifting the hips. Participants hold each position as long as possible to assess core strength and stability.

Time frame
8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up)

Secondary outcomes

1

Menopause symptoms

The Menopause Rating Scale (MRS) is a widely used tool for assessing symptoms related to menopause. The scoring scheme increases point by point with increasing subjectively perceived symptom severity for each of the 11 items (severity 0 \[no complaint\] to 4 score points \[very severe symptoms\]). The composite score for each of the dimensions (subscales) is based on the sum of the scores for each item of the respective dimensions. The composite score (total score) is the sum of the dimension scores.

Time frame
8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
2

Psychologic condition

The Beck Depression Inventory (BDI) is a widely used self-report inventory for measuring the severity of depression symptoms. It consists of 21 multiple-choice questions, each assessing a different symptom of depression such as sadness, pessimism, guilt, and suicidal thoughts. Respondents rate the severity of each symptom over the past two weeks. Scores are summed to yield a total score, with higher scores indicating more severe depressive symptoms. The BDI is frequently used in clinical and research settings to assess depression severity and monitor treatment progress.

Time frame
8 weeks (2 assessent times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)
3

Urinary symptoms

The Pelvic Floor Distress Inventory-20 (PFDI-20) is a recommended questionnaire for evaluating pelvic floor disorder (PFD) symptoms and measuring their impact on women's quality of life. This questionnaire is validated in Spanish. The PFDI-20 reflects different perspectives, thus including 20 questions divided into three symptom scales: pelvic organ prolapse symptoms (POP-DI) (questions 1 to 6); colorectal-anal symptoms (CRADI) (questions 7-14); and urinary symptoms (UDI) (questions 15-20). The questions in the CRADI scale are about fecal incontinence (FI), except for question 11, which addresses flatulence incontinence; whereas the UDI scale addresses urinary symptoms specifically. Question 16 pertains to urgency urinary incontinence (UUI), and question 17 pertains to stress urinary incontinence (SUI). Each question can be answered on four levels of dysfunction: none, mild, moderate, and severe.

Time frame
8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)
4

Pelvic floor health knowledge

Pelvic Floor Impact Questionnaire (PIKQ)It is a tool used to assess the impact of pelvic floor disorders, such as urinary incontinence, colorectal-anal symptoms, and genital prolapse, on various aspects of a person's life, including activities, relationships, and emotions. The questionnaire consists of seven questions for each symptom category (urine, colorectal-anal, and genital prolapse), with responses rated on a scale of none, mild, moderate, or severe. The total score is calculated by summing the scores from each category, with a maximum possible score of 300.

Time frame
8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up)

Other outcomes

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