- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04673318
Physical Rehabilitation of COVID-19 Survivors by Heat Therapy
27. april 2021 oppdatert av: University of Massachusetts, Amherst
Older adults and people with underlying medical conditions are at higher risk for developing serious complications related to SARS-CoV-2 resulting in prolonged sequelae.
The goal of this proposal is to compare the benefits of home-based lower limb heat therapy to exercise training on cardio-metabolic function and mobility in older adults during their convalescence from hospitalization due to SARS-CoV-2.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The novel coronavirus (severe acute respiratory syndrome [SARS]-CoV-2), first identified in December 2019 in Wuhan, China, has since spread worldwide.
Older adults and people with underlying medical conditions are at higher risk for developing serious complications and death related to SARS-CoV-2.
However, another challenge is arising in regards to the long-term prognosis of COVID-19 survivors.
Although limited, the available data on the medium-term outcomes of patients who survived COVID-19 all indicate prolonged symptom duration and disability in a large proportion of adults hospitalized with severe symptoms.
In addition, these patients, a majority of whom were older adults or patients with pre-existing health conditions, spent ~10-15 days bedridden and under intensive treatment, which can have lasting consequences on metabolism and cardiovascular functions, mobility, and eventually lead to long-term disabilities.
Upon discharge from the hospital, the main option for physical rehabilitation involves exercise training.
Although, exercise training can be effective to restore physical function, it is oftentimes associated with low adherence.
Considering the severe deconditioning accompanying hospitalization related to COVID-19, there is a critical need for the development of a rehabilitation strategy that is home-based and practical to individuals with diminished physical function.
Accordingly, the goal of this project is to compare the benefits of home-based lower limb chronic heat therapy to exercise training on skeletal muscle metabolism, vascular function and functional capacity in older adults during their convalescence from hospitalization due to SARS-CoV-2.
Late middle-age and older adults that have been discharged from a COVID-19 hospitalization will be randomly allocated to an exercise intervention group (EX, low resistance ~40 min, 3 times a week at home), a heat-treated group (HT, leg heated garments with skin temperature reaching ~40˚C, 40-55 min, 5 times a week at home), or a control group (CT) for 8 weeks.
Specific Aim 1 will test the hypothesis that local heat therapy in previously hospitalized COVID-19 patients can (i) enhance functional capacity, resulting in improvements in mobility and quality of life compared to a non-treated control group, and (ii) that these changes will be similar in magnitude to an exercise intervention.
Specific Aim 2 will test the hypothesis that local heat therapy in the same patients can (i) enhance insulin sensitivity as a consequence of improvements in mitochondrial and vascular function compared to a non-treated control group, and (ii) that these changes will be similar in magnitude to an exercise intervention.
Studietype
Intervensjonell
Registrering (Forventet)
87
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Massachusetts
-
Amherst, Massachusetts, Forente stater, 01003
- Rekruttering
- Institute of Applied Life Sciences
-
Ta kontakt med:
- Mary Emma Searles
- E-post: msearles@umass.edu
-
Ta kontakt med:
- Gwenael Layec, PhD
- Telefonnummer: 413-545-1451
- E-post: glayec@umass.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
55 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Women must not be taking hormone therapy
- Must have been hospitalized for, at least, 5 days for a COVID-19 related infection
- Must have been discharged from the hospital for, at least, 14 days
Exclusion Criteria:
- Orthopedic limitations that would prohibit from performing plantar-flexion or knee-extension exercise
- Contraindication to MRI (pacemaker, metal implants, or certain types of heart valves), or be at medical risk from undergoing an MRI examination
- Enrolled in a rehabilitation program
- BMI <40 kg/m2 and weigh <400lbs
- prior history of pulmonary embolism or deep vein thrombosis
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control
Course of recovery with standard of care.
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|
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Aktiv komparator: Exercise training
low resistance velocity based exercise training ~40 min, 3 times a week at home for 8 weeks
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A velocity based training program will be implemented at home using a mobile app allowing for the quantification the relative intensity.
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Eksperimentell: heat therapy
heat therapy (~40C skin temperature) with a leg garment 5 times a week for 40-55 min for 8 weeks
|
leg heated garments with circulating water to conduct heat therapy at home
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Gait speed
Tidsramme: 8 weeks
|
6-min walking distance
|
8 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Motor function
Tidsramme: 8 weeks
|
Short Physical Performance Battery score
|
8 weeks
|
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Glucose control
Tidsramme: 8 weeks
|
insulin and glucose levels during oral glucose tolerance test
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8 weeks
|
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Skeletal muscle mitochondrial function
Tidsramme: 8 weeks
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Change in phosphocreatine recovery kinetics measured by 31-PMRS
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8 weeks
|
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Vascular function
Tidsramme: 8 weeks
|
Change in reactive hyperemia
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8 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
26. februar 2021
Primær fullføring (Forventet)
1. desember 2024
Studiet fullført (Forventet)
1. desember 2024
Datoer for studieregistrering
Først innsendt
23. oktober 2020
Først innsendt som oppfylte QC-kriteriene
16. desember 2020
Først lagt ut (Faktiske)
17. desember 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. april 2021
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2151
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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