Effects of Crossover Point Exercise on Depression, Anxiety and Stress in Chinese Postmenopausal Women

Mental Health Clinical Trial

Official title:

Effects of Crossover Point Exercise on Depression, Anxiety and Stress in Chinese Postmenopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06449807
• Other study ID #: ECPEDASCPW
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Beijing Sport University
• Contact: Peizhen Zhang
• Phone: 01062989581
• Email: zhpzh[@]bsu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To analyze the effects of the Crossover Point (COP) Exercise Program on Chinese postmenopausal women.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Mental Health

Intervention

Behavioral:
• crossover point intensity exercise
crossover point intensity exercise

Locations

Country	Name	City	State
China	School of Sports Medicine and Rehabilitation, Beijing Sport University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Sport University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the beginning-at three months.
Secondary	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.	At the beginning-at three months.
Secondary	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.	At the beginning-at three months.
Secondary	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.	At the beginning-at three months.
Secondary	The Meaning in Life Questionnaire (MLQ)	A reliable, valid and practical screening tool for identifying and quantifying Meaning in Life.	At the beginning-at three months.
Secondary	The Subjective Happiness Scale (SMS)	Questionnaire that evaluates the subjective happiness.	At the beginning-at three months.
Secondary	Body composition	Body composition indicators analysis was assessed using DXA. Body compositon indicators include: fat mass,lean body mass,percentage of body fat.	At the beginning-at three months.