- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04673318
Physical Rehabilitation of COVID-19 Survivors by Heat Therapy
27. april 2021 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
87
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
-
Amherst, Massachusetts, Forenede Stater, 01003
- Rekruttering
- Institute of Applied Life Sciences
-
Kontakt:
- Mary Emma Searles
- E-mail: msearles@umass.edu
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Kontakt:
- Gwenael Layec, PhD
- Telefonnummer: 413-545-1451
- E-mail: glayec@umass.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
55 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control
Course of recovery with standard of care.
|
|
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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
|
A velocity based training program will be implemented at home using a mobile app allowing for the quantification the relative intensity.
|
|
Eksperimentel: heat therapy
heat therapy (~40C skin temperature) with a leg garment 5 times a week for 40-55 min for 8 weeks
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leg heated garments with circulating water to conduct heat therapy at home
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Gait speed
Tidsramme: 8 weeks
|
6-min walking distance
|
8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Motor function
Tidsramme: 8 weeks
|
Short Physical Performance Battery score
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8 weeks
|
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Glucose control
Tidsramme: 8 weeks
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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
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Change in reactive hyperemia
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8 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. februar 2021
Primær færdiggørelse (Forventet)
1. december 2024
Studieafslutning (Forventet)
1. december 2024
Datoer for studieregistrering
Først indsendt
23. oktober 2020
Først indsendt, der opfyldte QC-kriterier
16. december 2020
Først opslået (Faktiske)
17. december 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. april 2021
Sidst verificeret
1. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2151
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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