Quality of Life and MenopauseNCT03989453
Effects of Chi Kung to Improve the Symptoms of Menopause
A study testing Chi Kung in people with Quality of Life and Menopause, run by University of Jaén at 1 site in Spain.
Trial summary
To analyze the effects of a Chi Kung exercise program in Spanish menopausal women Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Quality of Life and Menopause
- What is being tested?
- Chi Kung
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2019to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cessation of menstrual activity for twelve months or more.
- Being able to understand the instructions and exercise protocols of this project
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Quality of Life and Menopause
- Being tested
- Chi Kung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chi KungOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chi Kung group | Experimental | This group receives physical training based on Chi Kung. Receives: Other: Chi Kung |
| Control Group | No intervention | This group does not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: At the beginning-at three months
WHQ (The Women's Health Questionnaire)
Measures the quality of life related to health specific for menopause
Measured: At the beginning-at three months
FSFI (The Female Sexual Function Index)
Questionnaire that evaluates the sexuality of women during the last four weeks.
Measured: 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.
Measured: 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.
Measured: At the beginning-at three months
Secondary outcomes (11)
Handgrip Strength
Dynamometer will be employed to assess handgrip strength.
Measured: At the beginning-at three months.
HADS (The Hospital Anxiety And Depression)
A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non-patients.
Measured: At the beginning-at three months.
SF-36 (The Short Form-36 Health Survey)
Used extensively for assessing health-related quality of life.
Measured: At the beginning-at three months.
TUG (Timed Up and Go test)
Is a simple test used to assess a person's mobility and physical function
Measured: At the beginning-at three months.
BMI (Body Mass Index)
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat
Measured: At the beginning-at three months.
Waist circumference
Is used to assess central fat distribution and degree of abdominal obesity.
Measured: At the beginning-at three months.
Waist-to-hip ratio
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.
Measured: At the beginning-at three months.
Cervantes Scale
Specific Scale for better quality of life related to specific health for menopause.
Measured: At the beginning-at three months.
The Female Genital Self-Image Scale (FGSIS)
Scale that evaluates the degree of satisfaction of their own genitals.
Measured: At the beginning-at three months.
FSS (Fatigue Severity Scale)
A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living.
Measured: At the beginning-at three months.
FES-I (Falls Efficacy Scale-International)
Questionnaire that evaluates the fear of falling.
Measured: At the beginning-at three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Jul 2019
- Primary completion23 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of Life and MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989453
- Sponsor's protocol ID
- University-Jaén
- Status last verified
- Sep 2021
- First submitted
- 4 Jun 2019
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36181076Carcelen-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.
PubMed 35179431Carcelen-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.
PubMed 34957157
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Menopause and Health. Effects of 12-week Chi Kung Program
- ClinicalTrials.gov ID
- NCT03989453
- Acronym / sponsor ID
- University-Jaén
- Conditions
- Quality of Life and Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Chi Kung group | Experimental | Other: Chi KungThis group receives physical training based on Chi Kung. |
| Control Group | No intervention | –This group does not receive any treatment. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Cessation of menstrual activity for twelve months or more.
- Being able to understand the instructions and exercise protocols of this project
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chi KungThe 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. | Other | Chi Kung group |
Primary outcome
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.
11 secondary outcomes
Handgrip Strength
Time frame: At the beginning-at three months.
HADS (The Hospital Anxiety And Depression)
Time frame: At the beginning-at three months.
SF-36 (The Short Form-36 Health Survey)
Time frame: At the beginning-at three months.
TUG (Timed Up and Go test)
Time frame: At the beginning-at three months.
BMI (Body Mass Index)
Time frame: At the beginning-at three months.
Waist circumference
Time frame: At the beginning-at three months.
Waist-to-hip ratio
Time frame: At the beginning-at three months.
Cervantes Scale
Time frame: At the beginning-at three months.
The Female Genital Self-Image Scale (FGSIS)
Time frame: At the beginning-at three months.
FSS (Fatigue Severity Scale)
Time frame: At the beginning-at three months.
FES-I (Falls Efficacy Scale-International)
Time frame: At the beginning-at three months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Derived from this study: PubMed 36181076Carcelen-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.
- Derived from this study: PubMed 35179431Carcelen-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.
- Derived from this study: PubMed 34957157Carcelen-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chi Kung in people with Quality of Life and Menopause, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSQI (Pittsburgh Sleep Quality Index) (time frame: At the beginning-at three months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03989453, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.