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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06312917
• Other study ID #: 2023PHB183
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 1, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Endometrium Cancer
• Physical Activity
• Weight Management

Intervention

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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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