Effect of Physical Activity Intervention on Overweight and Obese Patients With Endometrial Cancer

NCT ID: NCT06312917

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-02-01

Brief Summary

This study evaluated the clinical outcome of exercise management on patients with endometrial cancer treated with fertility preservation, including the effect of complete response rate, complete response time, recurrence rate, recurrence time, etc., and physical composition, to evaluate the effectiveness of physical activity on weight management.

Conditions

Endometrium Cancer; Physical Activity; Weight Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physical activity group

Exercise intervention According to the guidelines of the American Sports Medicine Association (ACSM) and the National Fitness guidelines of the General Administration of Sport of China

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

Exercise intervention According to the guidelines of the American Sports Medicine Association (ACSM) and the National Fitness guidelines of the General Administration of Sport of China, the FITT-VP principle of ACSM is adopted. The patients were given the intervention guidance of aerobic exercise, resistance training and flexibility training. During the training, the patients filled in the weekly training records, including the feeling after each training, physical dimension and other relevant information, and the nurses gave personalized exercise guidance according to the patients' conditions.The diet is to maintain a balanced diet.

control group

Maintain the current state of physical activity, do not do physical activity intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical activity

Exercise intervention According to the guidelines of the American Sports Medicine Association (ACSM) and the National Fitness guidelines of the General Administration of Sport of China, the FITT-VP principle of ACSM is adopted. The patients were given the intervention guidance of aerobic exercise, resistance training and flexibility training. During the training, the patients filled in the weekly training records, including the feeling after each training, physical dimension and other relevant information, and the nurses gave personalized exercise guidance according to the patients' conditions.The diet is to maintain a balanced diet.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participants were patients who met the following predefined eligibility criteria: Ages 20-40; Overweight or obese; The pathological diagnosis was EC (endometrioid, grade I, no myometrium invasion or metastasis). Not pregnant; Be willing to comply with test requirements after being fully informed of all risks and inconveniences associated with the test.

Exclusion Criteria

• Recurrent or metastatic disease; Currently participating in regular exercise at least 2 days per week; Pregnant at the start of the study; Or unwilling to comply with research requirements. Patients also completed the Physical Activity Readiness Questionnaire (PAR-Q) through a telephone interview. Patients with one or more potential exercise-related safety risks were excluded.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaodan Li

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2023PHB183

Identifier Type: -

Identifier Source: org_study_id