Effects of Chi Kung to Improve the Symptoms of Menopause

September 27, 2021 updated by: Agustín Aibar Almazán, University of Jaén

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Jaén, Spain, 23004
        • U.E.D. Virgen de la Capilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chi Kung group
This group receives physical training based on Chi Kung.
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.
No Intervention: Control Group
This group does not receive any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the beginning-at three months
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
At the beginning-at three months
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
At the beginning-at three months
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.
At the beginning-at three months
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.
At the beginning-at three months
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.
At the beginning-at three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip Strength
Time Frame: At the beginning-at three months.
Dynamometer will be employed to assess handgrip strength.
At the beginning-at three months.
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.
At the beginning-at three months.
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.
At the beginning-at three months.
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
At the beginning-at three months.
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
At the beginning-at three months.
Waist circumference
Time Frame: At the beginning-at three months.
Is used to assess central fat distribution and degree of abdominal obesity.
At the beginning-at three months.
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.
At the beginning-at three months.
Cervantes Scale
Time Frame: At the beginning-at three months.
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)
Time Frame: At the beginning-at three months.
Scale that evaluates the degree of satisfaction of their own genitals.
At the beginning-at three months.
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.
At the beginning-at three months.
FES-I (Falls Efficacy Scale-International)
Time Frame: At the beginning-at three months.
Questionnaire that evaluates the fear of falling.
At the beginning-at three months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jaén

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

September 23, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (Actual)

June 18, 2019

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • University-Jaén

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life and Menopause

Clinical Trials on Chi Kung

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe