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

NCT06449807 | Recruiting

• 1 other identifier: ECPEDASCPW
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mental Health

Keywords

Mental health; Sleep quality; Exercise; Body composition; Body image

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Body Mass Index (BMI )

  At the beginning-at three months.

• Body Image States Scale (BISS)

  At the beginning-at three months.

• Body Appreciation Scale-2 (BAS-2)

  At the beginning-at three months.

• The Meaning in Life Questionnaire (MLQ)

  At the beginning-at three months.

• The Subjective Happiness Scale (SMS)

  At the beginning-at three months.

Study Arms (2)

crossover point intensity exercise

ACTIVE COMPARATOR

Behavioral: crossover point intensity exercise

No Intervention

NO INTERVENTION

Interventions

crossover point intensity exercise BEHAVIORAL

crossover point intensity exercise

crossover point intensity exercise

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Sport University: lead

Study Sites (1)

School of Sports Medicine and Rehabilitation, Beijing Sport University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Sleep Initiation and Maintenance Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Peizhen Zhang

CONTACT

01062989581; zhpzh@bsu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: June 10, 2024
• Study Start: February 20, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-02

Locations

CN (1)