Physical Activity, Menopause and Health. Effects of 12-week Chi Kung Program
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Quality of Life and Menopause
- Sponsor
- University of Jaén
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- PSQI (Pittsburgh Sleep Quality Index)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Agustín Aibar Almazán
Principal investigator
University of Jaén
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
Outcomes
Primary Outcomes
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.
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
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
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.
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.
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.
Secondary Outcomes
- 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.)
- Waist circumference(At the beginning-at three months.)
- Waist-to-hip ratio(At the beginning-at three months.)
- Cervantes Scale(At the beginning-at three months.)
- The Female Genital Self-Image Scale (FGSIS)(At the beginning-at three months.)
- FSS (Fatigue Severity Scale)(At the beginning-at three months.)
- FES-I (Falls Efficacy Scale-International)(At the beginning-at three months.)