N/A
Completed N=40
Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors
Source: ClinicalTrials.gov NCT03722030 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Feasibility - Number of Participants Recruited — 20; 20 Participants
Summary
This 2-arm pilot trial will enroll 40 participants to test the feasibility, adherence, and benefits of a home-based strength training intervention for endometrial cancer survivors relative to a wait-listed control group.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility - Number of Participants Recruited |
20; 20 | — |
| PRIMARY Number of Participants Who Completed 100% of the Prescribed Exercises |
17; 0 | — |
| PRIMARY Number of Participants With Adverse Events |
0; 0 | — |
| SECONDARY Number of Participants Reporting "Very" or "Extremely" Satisfied With Intervention |
16 | — |
| SECONDARY Change in Hemoglobin A1c From Baseline |
4.7; 3.2 | — |
| SECONDARY Change in C-Reactive Protein From Baseline |
222.1; 108.6 | — |
| SECONDARY Change in Lean Muscle Mass From Baseline |
1.0; -0.7 | — |
| SECONDARY Change in Fat Mass From Baseline |
— | — |
| SECONDARY Change in Visceral Fat Mass From Baseline |
— | — |
| SECONDARY Change in Total Percent Body Fat From Baseline |
-0.6; -0.3 | — |
| SECONDARY Change in Number of Arm Curls Performed From Baseline |
4.9; 2.2 | — |
| SECONDARY Change in Number of Sit to Stand Repetitions Performed From Baseline |
3.3; 0.3 | — |
| SECONDARY Change in Handgrip Weight From Baseline |
0.7; -0.4 | — |
| SECONDARY Change in Sit and Reach Distance From Baseline |
0.9; -0.5 | — |
| SECONDARY Change in Back Scratch Distance From Baseline |
1.1; 0.1 | — |
| SECONDARY Change in 6-minute Walk Distance From Baseline |
70.0; 34.9 | — |
| SECONDARY Change in 8 Foot Up and Go Time From Baseline |
-0.7; -0.1 | — |
| SECONDARY FACT Scores |
146; 141; 146; 142; 146; 140 | — |
| SECONDARY Changes in FACT From Baseline |
-0.3; 0.6 | — |
| SECONDARY FACT-En Scores |
55.0; 54.5; 54.6; 54.7; 55.0; 55.0 | — |
| SECONDARY Changes in FACT-En From Baseline |
-0.0; 0.4 | — |
| SECONDARY FACT Physical Subscale Scores |
24.4; 24.0; 24.5; 23.9; 24.8; 24.5 | — |
| SECONDARY FACT Social Subscale Scores |
22.3; 20.6; 22.4; 20.8; 22.3; 19.7 | — |
| SECONDARY FACT Emotional Subscale Scores |
21.1; 20.4; 21.4; 20.7; 20.8; 20.2 | — |
| SECONDARY FACT Functional Subscale Scores |
23.0; 21.6; 22.9; 21.7; 23.3; 21.0 | — |
| SECONDARY Changes in FACT Subscales From Baseline |
0.4; 0.5; -0.0; -0.7; -0.4; -0.1 | — |
| SECONDARY Changes in Mental Well-being From Baseline |
-0.3; 1.5; -2.5; -2.0; -1.8; -0.8 | — |
| SECONDARY Changes in Self-Efficacy From Baseline |
-3.4; -6.0 | — |
| SECONDARY Self-Efficacy Scores |
63.4; 63.7; 57.3; 58.3; 60.0; 57.7 | — |
| SECONDARY Changes in Accelerometer-Measured Physical Activity From Baseline |
-77; 5; -41; 5; 0; -2 | — |
| SECONDARY Change in Steps Per Day From Baseline |
-1038; -92 | — |
Eligibility Criteria
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
- Documented diagnosis of Type I, stage I-IIIc endometrial cancer within the past 5 years
- Completion of current treatment for endometrial cancer, period of time of ≥10 weeks from treatment completion to study enrollment is required
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
- 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
Data sourced from ClinicalTrials.gov (NCT03722030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.