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Clinical Trials/NCT06312917
NCT06312917
Completed
Not Applicable

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

Peking University People's Hospital1 site in 1 country72 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometrium Cancer
Sponsor
Peking University People's Hospital
Enrollment
72
Locations
1
Primary Endpoint
Body weight
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
February 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiaodan Li

associate professor

Peking University People's Hospital

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.

Outcomes

Primary Outcomes

Body weight

Time Frame: Enrollment,four months after the intervention

Body weight measured naked or wearing work clothes of known weight, an electronic weight scale is used to measure

BMI

Time Frame: Enrollment,four months after the intervention

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

physical activity level

Time Frame: Enrollment,four months after the intervention

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.

Secondary Outcomes

  • triglyceride(Enrollment,four months after the intervention)
  • serum total cholesterol(Enrollment,four months after the intervention)
  • Waist Hip Ratio(Enrollment,four months after the intervention)

Study Sites (1)

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