Clinical trial NCT03989453: Effects of Chi Kung to Improve the Symptoms of Menopause
Official title: Physical Activity, Menopause and Health. Effects of 12-week Chi Kung Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life and Menopause
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 117
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: PSQI (Pittsburgh Sleep Quality Index)
timeFrame: At the beginning-at three months
measure: STABILOMETRIC PLATFORM
timeFrame: At the beginning-at three months
measure: WHQ (The Women's Health Questionnaire)
timeFrame: At the beginning-at three months
measure: FSFI (The Female Sexual Function Index)
timeFrame: At the beginning-at three months
measure: MRS (Menopause Rating Scale)
timeFrame: At the beginning-at three months
measure: ABC-16 (Activities Specific Balance Confidence Scale)
timeFrame: At the beginning-at three months
Secondary outcomes:
measure: Handgrip Strength
timeFrame: At the beginning-at three months.
measure: HADS (The Hospital Anxiety And Depression)
timeFrame: At the beginning-at three months.
measure: SF-36 (The Short Form-36 Health Survey)
timeFrame: At the beginning-at three months.
measure: TUG (Timed Up and Go test)
timeFrame: At the beginning-at three months.
measure: BMI (Body Mass Index)
timeFrame: At the beginning-at three months.
measure: Waist circumference
timeFrame: At the beginning-at three months.
measure: Waist-to-hip ratio
timeFrame: At the beginning-at three months.
measure: Cervantes Scale
timeFrame: At the beginning-at three months.
measure: The Female Genital Self-Image Scale (FGSIS)
timeFrame: At the beginning-at three months.
measure: FSS (Fatigue Severity Scale)
timeFrame: At the beginning-at three months.
measure: FES-I (Falls Efficacy Scale-International)
timeFrame: At the beginning-at three months.
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: U.E.D. Virgen de la Capilla
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.