Hjemmebasert trening Tele-rehabilitering etter COVID-19 (BOOST)
Hjemmebasert trening via telerehabilitering hos høyrisikoveteraner: virkningen av COVID-19-eksponering og sosioøkonomiske faktorer
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
There is an urgent need to understand the lasting impact of COVID-19 on the cardiopulmonary system to improve physical function and prevent long-lasting disability. Pertinent knowledge gaps regarding the post-recovery physiology driving any impairments need to be addressed to improve the quality of life in Veterans with prior SARS-CoV-2 infection. Further, it is important to devise successful rehabilitation strategies that can be safely conducted in a Veteran's home. Hence, the investigators propose to utilize VA Video Connect to deliver a home based, supervised group exercise program to Veteran COVID-19 survivors. The objective of this exercise trial is to determine the influence of COVID-19 on cardiorespiratory fitness, pulmonary and physical function and to investigate the effect of a home-based exercise tele-rehabilitation on these outcomes. The study design includes rural and urban sites and investigators with a history of VA rehabilitation collaboration. Moreover, the investigators will explore healthcare disparities related to COVID-19 which are associated with functional decline and may affect sustainability of exercise rehabilitation strategies deployed, if necessary, under social distancing restrictions.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Alice S Ryan, PhD
- Telefonnummer: (410) 605-7851
- E-post: Alice.Ryan@va.gov
Studiesteder
-
-
Maryland
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Baltimore, Maryland, Forente stater, 21201
- Rekruttering
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Hovedetterforsker:
- Alice S. Ryan, PhD
-
Ta kontakt med:
- Kristina Marcus, MS
- Telefonnummer: (410) 605-7000
- E-post: kristina.marcus@va.gov
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion 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 kilograms per square meter (kg/m2)
Exclusion Criteria:
- 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 (systolic blood pressure>180 &/or diastolic blood pressure> 110 millimeters of mercury at screening)
- screening electrocardiogram (EKG) with ischemia, complex arrhythmia, or high-grade block (per Minnesota Code)
- poorly controlled diabetes mellitus (fasting blood sugar>200 milligrams per deciliter, random blood sugar > 299 milligrams per deciliter, 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 oxygen, 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 times per week)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Tele-exercise
Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely. |
Exercise training 2x/week at home. Sessions include circuit exercises of aerobic and resistive training stations which are led remotely. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in volume of oxygen (VO2) peak
Tidsramme: Baseline and after 12 weeks tele-exercise
|
physical fitness, units are milliliters of oxygen per kilogram per minute (ml/kg/min) |
Baseline and after 12 weeks tele-exercise
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in 2-minute step test
Tidsramme: Baseline and after 12 weeks tele-exercise
|
physical function, units are number of times |
Baseline and after 12 weeks tele-exercise
|
|
chair stands
Tidsramme: Baseline and after 12 weeks tele-exercise
|
muscular strength, units are number of times |
Baseline and after 12 weeks tele-exercise
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Alice S. Ryan, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- F3639-R
- 5I01RX003639-02 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
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