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

Effects of Physical Activity Based on the Transtheoretical Model on Patients With Endometrial Cancer Undergoing Fertility-sparing Treatment: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Weight Management; Endometrium Cancer
• Intervention / Treatment: Behavioral: Physical activity

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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.
No Intervention: control group; Maintain the current state of physical activity, do not do physical activity intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight measured naked or wearing work clothes of known weight, an electronic weight scale is used to measure	Enrollment，four months after the intervention
BMI	Body mass index is a standard commonly used in the world to measure the degree of body fat and whether it is healthy. The formula is BMI= weight ÷ height*height	Enrollment，four months after the intervention
physical activity level	Physical activity energy was calculated using the formula of the International Physical Activity Questionnaire. Calculation Manual: Physical activity amount (MEt-minutes /week)= physical activity intensity MET value × physical activity time (minutes)/ day × activity days.	Enrollment，four months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum total cholesterol	Total cholesterol is the sum of all lipoproteins in the blood.The measurement was made by drawing venous blood. Suitable level for adults: 2.83~5.20mmol/L(110~200mg/dl)	Enrollment，four months after the intervention
Waist Hip Ratio	It is an indicator of the distribution of human body fat. It is the ratio of the waist and abdomen circumference marked by the umbilicus to the hip circumference marked by the anterior superior spine of the iliac (cm).	Enrollment，four months after the intervention
triglyceride	Serum triglyceride determination is a routine item in lipid analysis. The measurement was made by drawing venous blood. Normal reference value of serum triglyceride: 0.45 ~ 1.69mmol/L	Enrollment，four months after the intervention

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: 2023PHB183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No