Effects of Chi Kung to Improve the Symptoms of Menopause

NCT03989453 | Completed

• 1 other identifier: University-Jaén
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Quality of Life and Menopause

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (11)

• Handgrip Strength

  At the beginning-at three months.

• HADS (The Hospital Anxiety And Depression)

  At the beginning-at three months.

• SF-36 (The Short Form-36 Health Survey)

  At the beginning-at three months.

• TUG (Timed Up and Go test)

  At the beginning-at three months.

• BMI (Body Mass Index)

  At the beginning-at three months.

Study Arms (2)

Chi Kung group

EXPERIMENTAL

This group receives physical training based on Chi Kung.

Other: Chi Kung

Control Group

NO INTERVENTION

This group does not receive any treatment.

Interventions

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.

Chi Kung group

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cessation of menstrual activity for twelve months or more.
• Being able to understand the instructions and exercise protocols of this project

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

U.E.D. Virgen de la Capilla

Jaén, 23004, Spain

Location

Related Publications (3)

• 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.

  PMID: 36181076 DERIVED

• 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.

  PMID: 35179431 DERIVED

• 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.

  PMID: 34957157 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 18, 2019
• Study Start: July 1, 2019
• Primary Completion: September 23, 2019
• Study Completion: October 1, 2019
• Last Updated: October 5, 2021

Record last verified: 2021-09

Locations

ES (1)