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

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

Study Overview

• Status: Recruiting
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: crossover point intensity exercise

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peizhen Zhang; Phone Number: 01062989581; Email: zhpzh@bsu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • School of Sports Medicine and Rehabilitation, Beijing Sport University
    • Contact: Peizhen Zhang; Email: zhpzh@bsu.edu.cn
    • Principal Investigator: Peizhen Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention
Active Comparator: crossover point intensity exercise	Behavioral: crossover point intensity exercise; crossover point intensity exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
The Subjective Happiness Scale (SMS)	Questionnaire that evaluates the subjective happiness.	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.	At the beginning-at three months.

Collaborators and Investigators

• Sponsor: Beijing Sport University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Body composition; Mental health; Body image; Sleep quality
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: ECPEDASCPW

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No