Recruiting

Exercise Intervention

Sponsor:

University of Miami

Code:

NCT07359911

Conditions

Sarcoma

Eligibility Criteria

Sex: All

Age: 12 - 39

Healthy Volunteers: Not accepted

Interventions

Exercise Intervention

Usual Care Control

Exit Interview

Study Details

Brief summary:

The purpose of this study is to determine the effects of a multimodal exercise intervention on chemotherapy uptake in newly diagnosed pediatric, adolescent and young adult (AYA) Sarcoma patients.

Conditions

Sarcoma

Study ID

NCT07359911

Start date

Feb 5, 2026

Status verified date

Feb, 2026

Completion date

Aug 5, 2027

Anticipated

Primary completion date

Aug 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of Sarcoma
2. Pediatric or AYA (12-39 years old)
3. Able to provide written informed consent
4. Able to speak, read, and understand English or Spanish
5. Initiating first-line systemic therapy (Doxorubicin, Ifosfamide, Gemcitabine, Docetaxel, Trabectedin, Vincristine, Irinotecan, Temozolomide, Topotecan, Etoposide, Dacarbazine, Pazopanib, Tazemetostat, Imatinib, Sunitinib, Pembrolizumab, Nivolumab, Ipilumumab, Regorafenib, Atezulimumab). Participants can be enrolled up to 90 days after starting firstline systemic therapy.
6. Approval from a medical oncology provider to participate.
7. Having not consistently (not equal to or more than 50% of the time) engaged in more than 90 minutes of moderate or 45 minutes of vigorous physical activity per week over the past 3 months
8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months

Exclusion Criteria:

1. < 12 or >39 years old
2. Unable to provide consent
3. Unable to read or understand English or Spanish
4. Oxygen-dependent
5. Unable to walk 2 blocks without assistance (excluding canes)
6. Unstable bone metastases
7. More than 90 days from initiation of first-line systemic therapy.
8. Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention, as determined by the patient's provider and study clinician.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Exercise Intervention Group (EXE)

Participants in this group will undergo supervised multimodal (aerobic, resistance, balance) moderate-to-vigorous exercise intervention three 3 times per week for 12 weeks, a total of 36 sessions.

Total participation duration is about 12 weeks.

other: Usual Care Control Group (UC)

Participants in this group may opt to receive a weekly brief symptom self-assessment as a survey.

Total participation duration is about 12 weeks.

Interventions

Exercise Intervention

Each session will include a brief conversation and standardized symptom assessment, followed by a warm-up including stretching \& balance exercises, then a series of resistance exercises, ending with light-moderate intensity aerobic exercise (walking), with a target goal of 45-60 minutes total per session as tolerated by the patient.

Usual Care Control

A weekly brief symptom self-assessment as a survey will be delivered by Redcap survey, in person or remotely, or by telephone with researcher assistance. Completion of the survey will take approximately 10 minutes per week.

Exit Interview

A semi-structured interview will be administered at 12 weeks to the intervention (EXE) group only to explore self-determination and efficacy, as well as intervention acceptability.

Primary outcome measure

  • Feasibility of Participant Engagement at Time of Consent [ Time Frame: Baseline ]
  • Feasibility of Participant Engagement at All Time Points [ Time Frame: Up to 12 weeks ]
  • Acceptability of Participants that Feel Satisfied with Exercise Intervention [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Principal Investigator:

Tracy E Crane, PhD, RDN

More Information

Sponsor

University of Miami

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • Pediatric
  • Adolescent
  • Young Adult

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-02-18.