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Active, Not Recruiting

NCT Number: NCT07283029

Activity and Cancer Survivorship Exercise Pilot

This early phase I clinical trial measures the changes in functional fitness following home-based comprehensive exercise program in patients who have endometrial cancer who have completed treatment. Endometrial cancer is an increasingly common diagnosis, with health and quality of life concerns persisting after the active cancer treatment period. Exercise in cancer survivors has the potential to reduce the risk of death by improving cardiovascular fitness, quality of life, strength, longevity, and independence. A home-based exercise programs may be a feasible approach for exercise programming in patients who have endometrial cancer who have completed treatment.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 55242, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Willing to provide written informed consent
  • Willing to comply with all study procedures and be available for the duration of the study
  • Fluent in spoken and written English
  • Women 18-74 years of age
  • Documented diagnosis of type I, stage I-IIIc endometrial cancer within the past 5 years
  • Completion of current treatment for endometrial cancer
  • Technology access (cellphone with data, broadband internet, WiFi) for tele coaching
  • Pass the Physical Activity Readiness Questionnaire (PAR-Q)

Exclusion criteria

  • Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic or musculoskeletal limitations
  • Have evidence of recurrent or metastatic disease
  • Are currently performing resistance training >= 2 days per week
  • Are currently exceeding 150 minutes of at least moderate intensity activity per week
  • Report of chest pain, shortness of breath, fainting, or angina pectoris
  • Have physical disability that would limit range of motion through exercises such as sitting, standing and inability to walk one block
  • Plans to move from the area
  • Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to randomization
  • Women who are pregnant or breast-feeding
  • Not suitable for study participation due to other reasons at the discretion of the investigator
  • Failing the Physical Activity Readiness Questionnaire

Treatment and study plan

Functional fitness following home-based comprehensive exercise program

Other

Patients complete a home-based exercise program, receive remote health coaching sessions, and complete functional fitness tests on study. Patients also wear a Fitbit and receive health education on study.

Primary outcomes

  1. Chair sit to stand test

    Time frame: baseline, pre-intervention and immediately after the intervention

    Will be assessed using the Functional Fitness Test, which is a battery of six tests including the 30 second chair stand, the 30 second arm curl, the 6-minute walk, the chair sit and reach, the 8-foot up and go, and the back scratch tests. Mixed effects regression models will be used to estimate changes in each of the 6 tests included in the Functional Fitness Test from pre- to post-intervention. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean changes and associated 90% confidence intervals will be reported. Primary outcome is number of repetitions in the chair sit to stand test

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Up to 10 weeks

    Will be summarized by system organ class and/or preferred term, type of adverse event, severity (based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, [NCI CTCAE v 5.0] grades), and relation to study treatment. The most severe grade per patient will be reported.

  2. Muscle strengthening exercise session adherence

    Time frame: Up to 10 weeks

    Exercise session adherence will be defined as the proportion of planned exercise sessions in which a participant completes at least 50% of the prescribed exercises. The mean and associated 90% confidence interval will be reported

  3. Aerobic physical activity adherence

    Time frame: Up to 10 weeks

    Aerobic physical activity adherence will be defined as the proportion of planned weeks a participant accumulates 150 minutes of moderate intensity activity. The mean and associated 90% confidence interval will be reported.

  4. Tele coaching adherence

    Time frame: Up to 10 weeks

    Tele coaching adherence will be defined as the proportion of planned exercise sessions in which a participant completes. The mean and associated 90% confidence interval will be reported.

  5. Exercise program acceptability

    Time frame: Up to 10 weeks

    Acceptability will be assessed using Likert scale ratings of quality of exercise equipment, educational materials, health coaching, study feedback and distance-delivery format. Means and associated 90% confidence intervals will be reported for each item.

  6. Body weight

    Time frame: baseline, pre-intervention and immediately after the intervention

    Will be assessed by the within patient change of weight, waist and hip circumferences will be assessed from pre- to post-intervention. Mixed effects regression models will be used to estimate changes in anthropometrics. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean changes and associated 90% confidence intervals will be reported. Primary secondary outcome is changes in weight.

  7. Ambulatory activity levels

    Time frame: baseline, pre-intervention and immediately after the intervention

    Will be assessed by the within patient change in average daily steps taken within a week will be assessed from pre- to post-intervention. Mixed effects regression models will be used to estimate changes in ambulatory activity levels. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean and associated 90% confidence interval will be reported.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Evaluating Changes in Functional Fitness Following a 10-Week Home-Based Comprehensive Exercise Program in Endometrial Cancer Patients Who Have Completed Treatment

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Dec 15, 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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