NCT03813615

Study of the Effects of Pre-surgical Aerobic Exercise on Patients With Solid Tumors

Preoperative Aerobic Training for Solid Tumors (PRESTO 1): A Phase 0/1a Digitized Clinical Trial

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find the safest level of aerobic training for people about to undergo surgery for their cancer, and to learn what effects, if any, aerobic exercise has on these patients and the outcomes of their cancers. This part of the study (Phase 0) will evaluate the feasibility and quality of at-home exercise and assessment procedures and find out whether study participants are willing to practice continuous lifestyle monitoring using apps and electronic devices. Phase 1a will compare the effects and feasibility of six different doses of aerobic exercise and will continue evaluating the quality of at-home study procedures, which includes the use of continuous lifestyle monitoring through apps and electronic devices. In order to facilitate completion of the phase 1a component, we will backfill the 90, 225, and 300 mins/wk dosing cohorts with at least 4 patients in each dose cohort.

Conditions

• Preoperative Aerobic Training
• Solid Tumors

Interventions

Type	Name	Description
BEHAVIORAL	treadmill walking (Proof-of-Concept)	Individualized, progressive aerobic training consisting of treadmill walking for a total of 150 mins/wk delivered over 5 sessions/wk following a linear dosing schedule for a minimum of 2 weeks. All aerobic training treatment will be implemented and may be monitored using TeleEx. Participants may also perform up to two aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided with Appendix J - Unsupervised Home-Based Exercise Recording Form and Appendix K - Unsupervised Home-Based Exercise Instructions to record their sessions. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology. setting.
BEHAVIORAL	treadmill walking Dose-Finding / Escalation	Six doses of aerobic training ( 90mins/wk, 150 mins/wk, 225 mins/wk, 300 mins/wk \& 450mins/wk) delivered following either a standard linear (i.e., each dose of exercise is performed at the same intensity \& duration) or non-linear (i.e., exercise dose is continually altered \& progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule 3 to 6 times weekly (over a 7-day period) for a minimum 2 weeks. Aerobic training treatment will be implemented \& may be monitored using TeleEx. Patients may also perform up to three aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided a plan for their unsupervised session(s) verbally or via Portal Secure Messaging (PSM), as appropriate.

Timeline

• Start date: 2019-01-21
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2019-01-23
• Last updated: 2026-02-04

Locations

8 sites across 1 country: United States