RECRUITING

Home-Based Exercise Tele-Rehabilitation After COVID-19

Conditions

Post SARS-CoV2 (COVID-19)Exercise COVID-19 Cardiopulmonary

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The Coronavirus Disease 2019 (COVID-19) pandemic has resulted in catastrophic infections and fatalities across the nation. Many older Veterans with comorbidities are especially vulnerable to complications and poor recovery. This award will investigate the effect of a novel, home-based, supervised, group exercise tele-rehabilitation in Veterans recovered from COVID-19 on cardiopulmonary and physical function.

Official Title

Home-Based Exercise Tele-Rehabilitation in High-Risk Veterans: Impact of COVID-19 Exposure and Socioeconomic Factors

Quick Facts

Study Start:2023-06-29

Study Completion:2028-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05425264

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Veteran * documented COVID-19 \> 90 days ago * diagnosis of 2 of following conditions: hypertension, diabetes, cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease OR 1 condition and BMI \> 30 kg/m2	* myocardial infarction (within 3 months) * exertional or unstable angina (chest pain that limits activity) * severe congestive heart failure (EF \< 20% in last year or NYHA Classification III or IV) * uncontrolled hypertension (SBP \>180 \&/or DBP \> 110 mm Hg at screening) * screening EKG with ischemia, complex arrhythmia, or high-grade block (per Minnesota Code) * poorly controlled diabetes mellitus (FBS\>200 mg/dl, RBS \> 299 mg/dl, or HbA1C \> 10) * treatment for cancer except skin cancer (within 3 months) * peripheral vascular disease with claudication * severe arthritis limiting ambulation * neurologic disease limiting ambulation (weakness requiring assist device; severe neuropathy) * end stage liver disease (decompensated liver disease) * End stage renal failure (dialysis) * severe pulmonary disease (home O2, admission for dyspnea or pneumonia within 1 month) * high fall risk (history of falls, bone fracture) * dementia (based on Evaluation to Consent) * signs or symptoms of any medical comorbidity that would preclude exercise testing or training * exercises on routine basis (structured aerobic exercise \> 3 time per week)

Inclusion Criteria

Exclusion Criteria

* Veteran
* documented COVID-19 \> 90 days ago
* diagnosis of 2 of following conditions: hypertension, diabetes, cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease OR 1 condition and BMI \> 30 kg/m2

* myocardial infarction (within 3 months)
* exertional or unstable angina (chest pain that limits activity)
* severe congestive heart failure (EF \< 20% in last year or NYHA Classification III or IV)
* uncontrolled hypertension (SBP \>180 \&/or DBP \> 110 mm Hg at screening)
* screening EKG with ischemia, complex arrhythmia, or high-grade block (per Minnesota Code)
* poorly controlled diabetes mellitus (FBS\>200 mg/dl, RBS \> 299 mg/dl, or HbA1C \> 10)
* treatment for cancer except skin cancer (within 3 months)
* peripheral vascular disease with claudication
* severe arthritis limiting ambulation
* neurologic disease limiting ambulation (weakness requiring assist device; severe neuropathy)
* end stage liver disease (decompensated liver disease)
* End stage renal failure (dialysis)
* severe pulmonary disease (home O2, admission for dyspnea or pneumonia within 1 month)
* high fall risk (history of falls, bone fracture)
* dementia (based on Evaluation to Consent)
* signs or symptoms of any medical comorbidity that would preclude exercise testing or training
* exercises on routine basis (structured aerobic exercise \> 3 time per week)

Contacts and Locations

Study Contact

Alice S Ryan, PhD

CONTACT

(410) 605-7851

Alice.Ryan@va.gov

Principal Investigator

Alice S. Ryan, PhD

PRINCIPAL_INVESTIGATOR

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Locations (Sites)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Alice S. Ryan, PhD, PRINCIPAL_INVESTIGATOR, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-29

Study Completion Date2028-01-30

Study Record Updates

Study Start Date2023-06-29

Study Completion Date2028-01-30

Terms related to this study

Keywords Provided by Researchers

Exercise
COVID-19
Cardiopulmonary

Additional Relevant MeSH Terms

Post SARS-CoV2 (COVID-19)