Exercise Therapy in Cancer Patients Who Are Recovering From COVID-19

Study Overview
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Brief Summary
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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).

Official Title
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Exercise Therapy in Cancer Patients Hospitalized for COVID-19: A Digitized Clinical Trial

Conditions
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Covid19, Coronavirus, Cancer

Intervention / Treatment
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* Other: Aerobic Exercise Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants who were hospitalized for COVID-19<br>Participants will be post-cancer treatment patients who were hospitalized for COVID-19. | Other: Aerobic Exercise Therapy<br>* 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).<br>* Other names: AT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, Coronavirus, Cancer, Exercise, 21-101, Memorial Sloan Kettering Cancer Center