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- Klinische proef NCT03892460
Transitional Rehabilitation in CABG Patients
10 juli 2021 bijgewerkt door: Michael J. Toth, Ph.D., University of Vermont
Novel Transitional Rehabilitation Care in Coronary Artery Bypass Graft (CABG) Patients
The goal of this research study is to understand whether an at-home exercise program started soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital, can preserve or improve physical function.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
Coronary artery bypass graft (CABG) surgery is a common surgical procedures and an important treatment option for coronary artery disease.
The post-surgery period of rest and recovery is associated with cardiorespiratory and skeletal muscle deconditioning.
The goal of this research study is to understand whether an at-home exercise program started soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital, can serve as a bridge between surgery and the start of cardiac rehabilitation to preserve or improve physical function.
Volunteers will be randomly assigned to receive neuromuscular electrical stimulation (NMES) of their quadriceps muscles or not to receive NMES (control group).
Volunteers will be evaluated prior to CABG, upon discharge and 4 weeks Post-CABG surgery.
Assessments will include measurements of physical function by the Short Physical Performance Battery, 6 min walk tests and body composition analysis, as well as assessment of subjective physical functional capacity and quality of life using the Medical Outcomes Short form 36. Additionally, accelerometry will be used to monitor weight-bearing physical activity during the 4 week treatment phase.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
54
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Vermont
-
Burlington, Vermont, Verenigde Staten, 05405
- University of Vermont College of Medicine
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
50 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 50-80 yrs of age
- ambulatory
- scheduled for coronary artery bypass graft surgery
- able to provide informed consent
Exclusion Criteria:
- rheumatoid arthritis or other inflammatory/autoimmune disease
- cancer, excluding non-melanoma skin cancer
- exercise limiting peripheral vascular disease
- neuromuscular disease or neuromuscular dysfunction associated with cerebrovascular event
- body mass index >38 kg/m2
- valvular heart disease not corrected surgically
- lower extremity blood clot or implantable cardioverter-defibrillator
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Geen tussenkomst: Controle
Geen behandelingscontrole
|
|
Experimenteel: Treatment
Neuromuscular electrical stimulation
|
bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Short Physical Performance Battery
Tijdsspanne: 4 weeks
|
Short Physical Performance Battery is composed of three tasks assessing balance, gait speed, and ability to stand from a chair.
Units on a scale for each domain range from of 0-4 for a total score of 0 to 12, with a higher score indicating better physical function.
|
4 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
6 Minute Walk Distance
Tijdsspanne: 4 weeks
|
6 MW was developed to assess cardiopulmonary fitness in patients with lung and cardiac disease, and has been validated in cardiac surgery patients.
It assesses the distance that a patient can walk in 6 minutes time around a standard course.
|
4 weeks
|
Medical Outcomes Short Form 36 - Physical Function
Tijdsspanne: Hospital discharge and 4-weeks post-discharge
|
The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focused on limitations in physical function due to health problems.
Lower scores represent more physical function disability, while higher scores represent less disability.
|
Hospital discharge and 4-weeks post-discharge
|
Medical Outcome Short Form 36 - Role Physical
Tijdsspanne: Hospital discharge and 4-weeks post-discharge
|
The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focused on limitations in usual role activities because of physical health problems.
Lower scores represent more disability, while higher scores represent less disability.
|
Hospital discharge and 4-weeks post-discharge
|
Medical Outcomes Short Form 36 - Bodily Pain
Tijdsspanne: Hospital discharge and 4-week post-discharge
|
The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focused on bodily pain.
Lower scores represent more pain, while higher scores represent less pain.
|
Hospital discharge and 4-week post-discharge
|
Medical Outcomes Short Form 36 - General Health
Tijdsspanne: Hospital discharge and 4-week post-discharge
|
The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focused on self-reported general health.
Lower scores represent worse health, while higher scores represent better health.
|
Hospital discharge and 4-week post-discharge
|
Medical Outcomes Short Form 36 - Vitality
Tijdsspanne: Hospital discharge and 4-weeks post-discharge
|
The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focused on vitality (energy and fatigue).
Lower scores represent less vitality, while higher scores represent more vitality.
|
Hospital discharge and 4-weeks post-discharge
|
Medical Outcomes Short Form 36 - Social Function
Tijdsspanne: Hospital discharge and 4-weeks post-discharge
|
The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focuses on limitations in social activities because of physical or emotional problems.
Lower scores represent more more limitations, while higher scores represent less lmitations.
|
Hospital discharge and 4-weeks post-discharge
|
Medical Outcomes Short Form 36 - Role Emotional
Tijdsspanne: Hospital discharge and 4-week discharge
|
The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This sub-domain focuses on limitations in usual role activities because of emotional problems.
Lower scores represent more limitations, while higher scores represent less limitations.
|
Hospital discharge and 4-week discharge
|
Medical Outcomes Short Form 36
Tijdsspanne: Hospital discharge and 4-week post-discharge
|
The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status.
There are 36 questions that reflect eight sub-domains of health included in this questionnaire.
Scores for each domain represent weighted sums of the questions in each sub-domain.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
This measure represents the total computed score across all sub-domains.
Lower scores represent worse overall health, while higher scores represent better health.
|
Hospital discharge and 4-week post-discharge
|
Physical Activity
Tijdsspanne: Daily from discharge to 4-week post-discharge evaluation
|
Physical activity was measured throughout the intervention in control and treatment groups and data.
Data were analyzed by regression analysis to obtain the best fit line for the data and to compute a slope of the change in step count with day post-discharge to examine whether groups differed in their rate of recovery of weight-bearing activity (ie, walking).
|
Daily from discharge to 4-week post-discharge evaluation
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2017
Primaire voltooiing (Werkelijk)
24 oktober 2019
Studie voltooiing (Werkelijk)
24 oktober 2019
Studieregistratiedata
Eerst ingediend
26 maart 2019
Eerst ingediend dat voldeed aan de QC-criteria
26 maart 2019
Eerst geplaatst (Werkelijk)
27 maart 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 augustus 2021
Laatste update ingediend die voldeed aan QC-criteria
10 juli 2021
Laatst geverifieerd
1 juli 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 17-0413
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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