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

Phase 1
Active, not recruiting
Conditions
Cancer
Covid19
Coronavirus
Interventions
Other: Aerobic Exercise Therapy
Registration Number
NCT04824443
Lead Sponsor
Memorial Sloan Kettering Cancer Center
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
3
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Participants who were hospitalized for COVID-19Aerobic Exercise TherapyParticipants will be post-cancer treatment patients who were hospitalized for COVID-19.
Primary Outcome Measures
NameTimeMethod
Frequency of serious adverse events during study-related assessments30 weeks

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

🇺🇸

Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

🇺🇸

Middletown, New Jersey, United States

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

🇺🇸

Commack, New York, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

🇺🇸

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

🇺🇸

Uniondale, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

🇺🇸

New York, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

🇺🇸

Harrison, New York, United States

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