Effects of Chi Kung to Improve the Symptoms of Menopause

Quality of Life and Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989453
• Other study ID #: University-Jaén
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: September 2021
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: October 1, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life and Menopause

Intervention

Other:
• Chi Kung
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.

Locations

Country	Name	City	State
Spain	U.E.D. Virgen de la Capilla	Jaén

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	WHQ (The Women's Health Questionnaire)	Measures the quality of life related to health specific for menopause	At the beginning-at three months
Primary	FSFI (The Female Sexual Function Index)	Questionnaire that evaluates the sexuality of women during the last four weeks.	At the beginning-at three months
Primary	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
Primary	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	Handgrip Strength	Dynamometer will be employed to assess handgrip strength.	At the beginning-at three months.
Secondary	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.
Secondary	SF-36 (The Short Form-36 Health Survey)	Used extensively for assessing health-related quality of life.	At the beginning-at three months.
Secondary	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.
Secondary	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.
Secondary	Waist circumference	Is used to assess central fat distribution and degree of abdominal obesity.	At the beginning-at three months.
Secondary	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.
Secondary	Cervantes Scale	Specific Scale for better quality of life related to specific health for menopause.	At the beginning-at three months.
Secondary	The Female Genital Self-Image Scale (FGSIS)	Scale that evaluates the degree of satisfaction of their own genitals.	At the beginning-at three months.
Secondary	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.
Secondary	FES-I (Falls Efficacy Scale-International)	Questionnaire that evaluates the fear of falling.	At the beginning-at three months.