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Effects of Chi Kung to Improve the Symptoms of Menopause

Not Applicable
Completed
Conditions
Quality of Life and Menopause
Interventions
Other: Chi Kung
Registration Number
NCT03989453
Lead Sponsor
University of Jaén
Brief Summary

To analyze the effects of a Chi Kung exercise program in Spanish menopausal women

Detailed Description

This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.

The study will define two groups:

A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.

An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Chi Kung exercises.

Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
117
Inclusion Criteria
  • Cessation of menstrual activity for twelve months or more.
  • Being able to understand the instructions and exercise protocols of this project
Exclusion Criteria
  • Contraindications for the performance of physical tests, cancer or serious illness, musculoskeletal and neurological diseases, taking of drugs that affect the central nervous system or antidepressants, or lack of will to participate in the study

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Chi Kung groupChi KungThis group receives physical training based on Chi Kung.
Primary Outcome Measures
NameTimeMethod
PSQI (Pittsburgh Sleep Quality Index)At the beginning-at three months

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.

STABILOMETRIC PLATFORMAt the beginning-at three months

instrument composed of resistive pressure sensors, used to measure the static or postural balance. The test was performed under both eyes-open and eyes-closed conditions

WHQ (The Women's Health Questionnaire)At the beginning-at three months

Measures the quality of life related to health specific for menopause

FSFI (The Female Sexual Function Index)At the beginning-at three months

Questionnaire that evaluates the sexuality of women during the last four weeks.

MRS (Menopause Rating Scale)At the beginning-at three months

Assesses the severity of menopause-related complaints and the impact on health-related quality of life. Calculated by adding up the 11 questions in the questionnaire. Each item has a score of 0-1-2-3-4, with 4 being the worst score.

ABC-16 (Activities Specific Balance Confidence Scale)At the beginning-at three months

Questionnaire that assesses balance confidence in performing activities of daily living. It is calculated by adding up the 16 responses of the questionnaire, with 0 being the minimum score and 100 being the maximum score. The higher value represents a better result.

Secondary Outcome Measures
NameTimeMethod
Handgrip StrengthAt the beginning-at three months.

Dynamometer will be employed to assess handgrip strength.

HADS (The Hospital Anxiety And Depression)At the beginning-at three months.

A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non-patients.

SF-36 (The Short Form-36 Health Survey)At the beginning-at three months.

Used extensively for assessing health-related quality of life.

TUG (Timed Up and Go test)At the beginning-at three months.

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

BMI (Body Mass Index)At the beginning-at three months.

Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat

Waist circumferenceAt the beginning-at three months.

Is used to assess central fat distribution and degree of abdominal obesity.

Waist-to-hip ratioAt the beginning-at three months.

Is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement.

Cervantes ScaleAt the beginning-at three months.

Specific Scale for better quality of life related to specific health for menopause.

The Female Genital Self-Image Scale (FGSIS)At the beginning-at three months.

Scale that evaluates the degree of satisfaction of their own genitals.

FSS (Fatigue Severity Scale)At the beginning-at three months.

A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living.

FES-I (Falls Efficacy Scale-International)At the beginning-at three months.

Questionnaire that evaluates the fear of falling.

Trial Locations

Locations (1)

U.E.D. Virgen de la Capilla

🇪🇸

Jaén, Spain

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