Mental HealthNCT06449807
Effects of Crossover Point Exercise on Depression, Anxiety and Stress in Chinese Postmenopausal Women
A study testing crossover point intensity exercise in people with Mental Health, run by Beijing Sport University at 1 site in China.
Trial summary
To analyze the effects of the Crossover Point (COP) Exercise Program on Chinese postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- crossover point intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2024to 31 Dec 2024
- 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 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women without incapacitating chronic disease or contraindications to exercise
- baseline mental health
- no severe chronic diseases or exercise contraindications
- ability to understand the research details and voluntarily sign the informed consent form.
Who cannot join
- Women with undetermined menopause；
- BMI <18.5 kg/m2 or BMI >28 kg/m2
- uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >110 mmHg)
- life-threatening illness with a prognosis of <5 years
- currently receiving estrogen therapy
- currently taking medication that may affect psychological testing
- contraindications to exercise
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School of Sports Medicine and Rehabilitation, Beijing Sport University
Beijing
Peizhen Zhang, zhpzh@bsu.edu.cn
Peizhen Zhang
About this study
To analyze the effects of the Crossover Point (COP) Exercise Program on Chinese postmenopausal 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-posttest design has been used.
- Conditions
- Mental Health
- Being tested
- crossover point intensity exercise
- Keywords
- Mental health, Sleep quality, Exercise, Body composition, Body image
- Medical subject headings
- Psychological Well-Being, Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crossover point intensity exerciseBehavioural
crossover point intensity exercise
| Study group | Role | What they receive |
|---|---|---|
| crossover point intensity exercise | Active comparator | Not described Receives: Behavioral: crossover point intensity exercise |
| No Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASS-21 (Depression Anxiety Stress Scale-21)
The scale has 21 questions that cover a wide range of symptoms of depression, anxiety, and stress. Each of the questions was stated in the first person, assertive tone, and required the participants to grade on a 4-point scale their experiences with a score of 0 (did not apply to me at all), 1 (applied to me to some degree or some of the time), 2 (applied to me to a considerable degree or a good part of the time), and 3 (applied to me very much or most of the time). The higher value represents a worse result.
Measured: At the beginning-at three months.
Secondary outcomes (6)
Body Mass Index (BMI )
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.
Body Image States Scale (BISS)
The BISS contains six items that assess different aspects of body image such as physical appearance, body size and shape, body weight, and attractiveness, as well as concerns about how one looks relative to others. Participants were instructed to complete the questionnaire describing ''How are you feeling right now?'' A higher score represents higher body image satisfaction. The BISS is an internally consistent scale, and construct validity has been confirmed.
Measured: At the beginning-at three months.
Body Appreciation Scale-2 (BAS-2)
The BAS-2 used in this study is the version revised by Swami et al., it comprises a total of 10 items, scored using a Likert five-point scale, corresponding to the options "Never, Rarely, Sometimes, Often, Always," with each item scored from 1 to 5 points. A higher score indicates a stronger appreciation of one's own body.
Measured: At the beginning-at three months.
The Meaning in Life Questionnaire (MLQ)
A reliable, valid and practical screening tool for identifying and quantifying Meaning in Life.
Measured: At the beginning-at three months.
The Subjective Happiness Scale (SMS)
Questionnaire that evaluates the subjective happiness.
Measured: At the beginning-at three months.
Body composition
Body composition indicators analysis was assessed using DXA. Body compositon indicators include: fat mass，lean body mass，percentage of body fat.
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 posted10 Jun 2024
- Study start20 Feb 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449807
- Sponsor's protocol ID
- ECPEDASCPW
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Crossover Point Exercise on Depression, Anxiety and Stress in Chinese Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06449807
- Acronym / sponsor ID
- ECPEDASCPW
- Conditions
- Mental Health
- Keywords
- Mental health, Sleep quality, Exercise, Body composition, Body image
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jun 2024 (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 the Crossover Point (COP) Exercise Program on Chinese postmenopausal 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-posttest design has been used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| crossover point intensity exercise | Active comparator | Behavioral: crossover point intensity exercise |
| No Intervention | No intervention | – |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women without incapacitating chronic disease or contraindications to exercise
- baseline mental health
- no severe chronic diseases or exercise contraindications
- ability to understand the research details and voluntarily sign the informed consent form.
Key exclusion criteria (7 listed)
- Women with undetermined menopause；
- BMI <18.5 kg/m2 or BMI >28 kg/m2
- uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >110 mmHg)
- life-threatening illness with a prognosis of <5 years
- currently receiving estrogen therapy
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 |
|---|---|---|
| crossover point intensity exercisecrossover point intensity exercise | Behavioural | crossover point intensity exercise |
Primary outcome
DASS-21 (Depression Anxiety Stress Scale-21)
Time frame: At the beginning-at three months.
The scale has 21 questions that cover a wide range of symptoms of depression, anxiety, and stress. Each of the questions was stated in the first person, assertive tone, and required the participants to grade on a 4-point scale their experiences with a score of 0 (did not apply to me at all), 1 (applied to me to some degree or some of the time), 2 (applied to me to a considerable degree or a good part of the time), and 3 (applied to me very much or most of the time). The higher value represents a worse result.
6 secondary outcomes
Body Mass Index (BMI )
Time frame: At the beginning-at three months.
Body Image States Scale (BISS)
Time frame: At the beginning-at three months.
Body Appreciation Scale-2 (BAS-2)
Time frame: At the beginning-at three months.
The Meaning in Life Questionnaire (MLQ)
Time frame: At the beginning-at three months.
The Subjective Happiness Scale (SMS)
Time frame: At the beginning-at three months.
Body composition
Time frame: At the beginning-at three months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing crossover point intensity exercise in people with Mental Health, run by Beijing Sport University at 1 site in China.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peizhen Zhang (01062989581, zhpzh@bsu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASS-21 (Depression Anxiety Stress Scale-21) (time frame: At the beginning-at three months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2024.