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Completed

NCT Number: NCT03989453

Effects of Chi Kung to Improve the Symptoms of Menopause

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

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Key information

Conditions

Quality of Life and Menopause

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

U.E.D. Virgen de la Capilla

Jaén, 23004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chi Kung

Other

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.

Primary outcomes

  1. PSQI (Pittsburgh Sleep Quality Index)

    Time frame: 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.

  2. STABILOMETRIC PLATFORM

    Time frame: At 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

  3. WHQ (The Women's Health Questionnaire)

    Time frame: At the beginning-at three months

    Measures the quality of life related to health specific for menopause

  4. FSFI (The Female Sexual Function Index)

    Time frame: At the beginning-at three months

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

  5. MRS (Menopause Rating Scale)

    Time frame: 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.

  6. ABC-16 (Activities Specific Balance Confidence Scale)

    Time frame: 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 outcomes

  1. Handgrip Strength

    Time frame: At the beginning-at three months.

    Dynamometer will be employed to assess handgrip strength.

  2. HADS (The Hospital Anxiety And Depression)

    Time frame: At the beginning-at three months.

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

  3. SF-36 (The Short Form-36 Health Survey)

    Time frame: At the beginning-at three months.

    Used extensively for assessing health-related quality of life.

  4. TUG (Timed Up and Go test)

    Time frame: At the beginning-at three months.

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

  5. BMI (Body Mass Index)

    Time frame: 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

  6. Waist circumference

    Time frame: At the beginning-at three months.

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

  7. Waist-to-hip ratio

    Time frame: At 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.

  8. Cervantes Scale

    Time frame: At the beginning-at three months.

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

  9. The Female Genital Self-Image Scale (FGSIS)

    Time frame: At the beginning-at three months.

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

  10. FSS (Fatigue Severity Scale)

    Time frame: 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.

  11. FES-I (Falls Efficacy Scale-International)

    Time frame: At the beginning-at three months.

    Questionnaire that evaluates the fear of falling.

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2019
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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