Effects of Chi Kung to Improve the Symptoms of Menopause

NCT ID: NCT03989453

Last Updated: 2021-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Quality of Life and Menopause

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
The assignment to the groups will be of simple random type and hidden. Those responsible for admitting patients to the intervention phase will not know what group has been assigned each. This assignment will be made in advance by a researcher who will not intervene in the later stages of evaluation, intervention, data recording and elaboration of database. The assignment will be communicated through sealed and totally opaque envelopes.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chi Kung group

This group receives physical training based on Chi Kung.

Group Type EXPERIMENTAL

Chi Kung

Intervention Type 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.

Control Group

This group does not receive any treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Jaén

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Agustín Aibar Almazán

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

U.E.D. Virgen de la Capilla

Jaén, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Carcelen-Fraile MDC, Aibar-Almazan A, Martinez-Amat A, Jimenez-Garcia JD, Brandao-Loureiro V, Garcia-Garro PA, Fabrega-Cuadros R, Rivas-Campo Y, Hita-Contreras F. Qigong for mental health and sleep quality in postmenopausal women: A randomized controlled trial. Medicine (Baltimore). 2022 Sep 30;101(39):e30897. doi: 10.1097/MD.0000000000030897.

Reference Type DERIVED
PMID: 36181076 (View on PubMed)

Carcelen-Fraile MDC, Hita-Contreras F, Martinez-Amat A, Loureiro VB, Loureiro NEM, Jimenez-Garcia JD, Fabrega-Cuadros R, Aibar-Almazan A. Impact of Qigong exercises on the severity of the menopausal symptoms and health-related quality of life: A randomised controlled trial. Eur J Sport Sci. 2023 Apr;23(4):656-664. doi: 10.1080/17461391.2022.2044915. Epub 2022 Mar 7.

Reference Type DERIVED
PMID: 35179431 (View on PubMed)

Carcelen-Fraile MDC, Aibar-Almazan A, Martinez-Amat A, Brandao-Loureiro V, Jimenez-Garcia JD, Castellote-Caballero Y, Hita-Contreras F. Qigong for Muscle Strength and Static Postural Control in Middle-Aged and Older Postmenopausal Women: A Randomized Controlled Trial. Front Med (Lausanne). 2021 Dec 8;8:784320. doi: 10.3389/fmed.2021.784320. eCollection 2021.

Reference Type DERIVED
PMID: 34957157 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

University-Jaén

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Calisthenic Exercises
NCT06396936 COMPLETED NA