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Completed

NCT Number: NCT06312917

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

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.

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Key information

Conditions

Endometrium Cancer Behavior Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Motor Activity Neoplasms Neoplasms by Site Physical Activity Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms Weight Management

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. serum total cholesterol

    Time frame: Enrollment，four months after the intervention

    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)

  2. Waist Hip Ratio

    Time frame: Enrollment，four months after the intervention

    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).

  3. triglyceride

    Time frame: Enrollment，four months after the intervention

    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

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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