Effects of Chi Kung to Improve the Symptoms of Menopause

Study Overview
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Brief Summary
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To analyze the effects of a Chi Kung exercise program in Spanish menopausal women

Detailed Description
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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.

Official Title
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Physical Activity, Menopause and Health. Effects of 12-week Chi Kung Program

Conditions
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Quality of Life and Menopause

Intervention / Treatment
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* Other: Chi Kung


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chi Kung group<br>This group receives physical training based on Chi Kung. | Other: Chi Kung<br>* The duration of the intervention is 12 weeks, with 2 sessions per week of Chi Kung. Each session lasts approximately 1 hour and is structured in three parts: initial warm-up (Based on breathing and concentration exercises), of 10 minutes duration, a 40-45 minute Chi Kung session and finally 10 minutes of guided relaxation.<br>|
| No Intervention: Control Group<br>This group does not receive any treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the beginning-at three months | 
| STABILOMETRIC PLATFORM | 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 | At the beginning-at three months | 
| WHQ (The Women's Health Questionnaire) | Measures the quality of life related to health specific for menopause | At the beginning-at three months | 
| FSFI (The Female Sexual Function Index) | Questionnaire that evaluates the sexuality of women during the last four weeks. | At the beginning-at three months | 
| MRS (Menopause Rating Scale) | 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. | At the beginning-at three months | 
| ABC-16 (Activities Specific Balance Confidence Scale) | 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. | At the beginning-at three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handgrip Strength | Dynamometer will be employed to assess handgrip strength. | At the beginning-at three months. | 
| HADS (The Hospital Anxiety And Depression) | A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non-patients. | At the beginning-at three months. | 
| SF-36 (The Short Form-36 Health Survey) | Used extensively for assessing health-related quality of life. | At the beginning-at three months. | 
| TUG (Timed Up and Go test) | Is a simple test used to assess a person's mobility and physical function | At the beginning-at three months. | 
| BMI (Body Mass Index) | Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat | At the beginning-at three months. | 
| Waist circumference | Is used to assess central fat distribution and degree of abdominal obesity. | At the beginning-at three months. | 
| Waist-to-hip ratio | 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. | At the beginning-at three months. | 
| Cervantes Scale | Specific Scale for better quality of life related to specific health for menopause. | At the beginning-at three months. | 
| The Female Genital Self-Image Scale (FGSIS) | Scale that evaluates the degree of satisfaction of their own genitals. | At the beginning-at three months. | 
| FSS (Fatigue Severity Scale) | A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living. | At the beginning-at three months. | 
| FES-I (Falls Efficacy Scale-International) | Questionnaire that evaluates the fear of falling. | At the beginning-at three months. |