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

NCT06312917 | Completed

• 1 other identifier: 2023PHB183
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• serum total cholesterol

  Enrollment，four months after the intervention

• Waist Hip Ratio

  Enrollment，four months after the intervention

• triglyceride

  Enrollment，four months after the intervention

Study Arms (2)

Physical activity group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

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.

Physical activity group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 15, 2024
• Study Start: August 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: February 1, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

CN (1)