Exercise Therapy in Cancer Patients Who Are Recovering From COVID-19
1 other identifier
interventional
3
1 country
7
Brief Summary
The purpose of the study is to evaluate the safety and tolerability of a 30-week aerobic exercise therapy program in cancer patients recovering from COVID-19. The study will look at whether the aerobic exercise therapy causes few or mild side effects in participants. Aerobic exercise is physical activity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for several minutes at a time. The aerobic exercise therapy being used in this study will be a walking program that will be adjusted so it matches participant fitness levels (how much exercise you can handle).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 covid19
Started Mar 2021
Longer than P75 for phase_1 covid19
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2021
CompletedStudy Start
First participant enrolled
March 29, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2025
CompletedOctober 27, 2025
October 1, 2025
4.6 years
March 29, 2021
October 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of serious adverse events during study-related assessments
Safety will be evaluated by the frequency of serious (i.e., life-threatening, hospitalization, significant incapacity, important medical events) adverse events during study-related assessments and exercise sessions according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
30 weeks
Study Arms (1)
Participants who were hospitalized for COVID-19
EXPERIMENTALParticipants will be post-cancer treatment patients who were hospitalized for COVID-19.
Interventions
Aerobic Exercise Therapy/AT will consist of 30 weeks of treadmill walking sessions. AT will consist of supervised, individualized walking delivered up to 6 times weekly (over a 7-day period) to achieve a cumulative total duration ranging from 90 mins/wk up to 375 mins/wk following a non-linear dosing schedule. The planned dose and scheduling of AT will be continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period (i.e., non-linear periodized schedule).
Eligibility Criteria
You may qualify if:
- Age ≥ 18
- Previously admitted to a hospital for Covid-19
- Discharged from hospital for at least 30 days
- Previously treated for cancer at MSK
- Interval of ≥ 12 months but ≤ 10 years following completion of primary non-hormonal anti-cancer therapy (current endocrine therapy and maintenance therapy allowed)
- Space to house a treadmill at personal residence
- Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+)
- Performing less than 90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self-report
- If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.
- Women \<50 years old who are of child-bearing potential must have a negative pregnancy test within 14 days of enrollment.
You may not qualify if:
- Currently receiving home oxygen after discharge
- Enrollment onto any other interventional investigational study
- Current treatment for any other diagnosis of invasive cancer of any kind
- Distant metastatic malignancy of any kind
- Receiving non-hormonal anticancer therapy
- Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Publications (1)
Scott JM, Qiu Z, Rahman J, Moskowitz CS, Michalski MG, Lehman S, Lee CP, Harrison J, Yu AF, Marouf A, Vardhana S, Boutros PC, Jones LW. Case Report: Decentralized trial of tolerability-adapted exercise therapy after severe Covid-19. Front Immunol. 2025 Apr 3;16:1529385. doi: 10.3389/fimmu.2025.1529385. eCollection 2025.
PMID: 40248705DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Scott, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2021
First Posted
April 1, 2021
Study Start
March 29, 2021
Primary Completion
October 24, 2025
Study Completion
October 24, 2025
Last Updated
October 27, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.