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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04824443

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Covid19 Coronavirus Cancer	Other: Aerobic Exercise Therapy	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 29, 2021

Anticipated Primary Completion Date :

Mar 29, 2023

Anticipated Study Completion Date :

Mar 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants who were hospitalized for COVID-19 Participants will be post-cancer treatment patients who were hospitalized for COVID-19.	Other: Aerobic Exercise Therapy 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). Other Names: AT

Arm

Intervention/Treatment

Experimental: Participants who were hospitalized for COVID-19

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

Other: Aerobic Exercise Therapy

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).

Other Names:

Outcome Measures

Primary Outcome Measures

Frequency of serious adverse events during study-related assessments [30 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey	United States	07920
2	Memoral Sloan Kettering Monmouth (Limited protocol activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)	Commack	New York	United States	11725
5	Memoral Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York	United States	11553