NCT04824443

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1 covid19

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_1 covid19

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2025

Completed
Last Updated

October 27, 2025

Status Verified

October 1, 2025

Enrollment Period

4.6 years

First QC Date

March 29, 2021

Last Update Submit

October 24, 2025

Conditions

Keywords

Covid19CoronavirusCancerExercise21-101Memorial Sloan Kettering Cancer Center

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

EXPERIMENTAL

Participants will be post-cancer treatment patients who were hospitalized for COVID-19.

Other: Aerobic Exercise Therapy

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).

Also known as: AT
Participants who were hospitalized for COVID-19

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

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.

Related Links

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsNeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Jessica Scott, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

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.

Locations