Protocolo de plataforma RECOVER-ENERGIZE_Apéndice B (estimulación estructurada (PEM))
RECOVER-ENERGIZE: Protocolo de plataforma para la evaluación de intervenciones para la intolerancia al ejercicio en las secuelas posagudas de la infección por SARS-CoV-2 (PASC)
This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes.
This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC).
The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Study interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix. Study intervention appendices may be added or removed according to adaptive design and/or emerging evidence.
The platform protocol enrolls participants who meet study eligibility criteria. After completing initial screening assessments, eligible participants are assigned to one of the study intervention appendices that are actively enrolling. Participants must meet certain criteria within a specific appendix in order to be included in that appendix. Once assigned to an appendix, eligible participants are randomized to either the study intervention group or a control group.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- All sites listed under NCT06404047
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
• See NCT06404047 for RECOVER-ENERGIZE: Platform Protocol level inclusion and exclusion criteria which applies to this appendix
Additional Appendix B (Structured Pacing (PEM)) Level Inclusion Criteria:
- Participant identifies new PEM following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent
- Score of 2 or greater for both frequency and severity for any of the first 5 questions on the Screening mDSQ-PEM AND Answer of YES to either item 7 or 8 on Screening mDSQ-PEM, and response of >14 h in item 9.
or Score of 3 or greater on any severity question(regardless) and answer of YES to either item 7 or 8 on the Screening mDSQ-PEM, and response of >14h in item 9.
Additional Appendix B (Structured Pacing (PEM)) Level Exclusion Criteria:
- Inability to attend in-person screening visit or participate in weekly visits (in-person [≥ 1] and remote)
- Participant was previously enrolled in Appendix A of this protocol and has NOT completed the full study follow-up period of Appendix A
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Structured Pacing (PEM)
Participants in this group will complete weekly pacing sessions for 12 weeks. Pacing sessions will last about 30 minutes, as tolerated. Each participant will meet with a provider 'pacing coach' who has received study-specific education about PEM and how to create and manage pacing strategies for participants. Sessions include PEM symptom and trigger assessment; task, function and activity analysis; adaptations and modifications. |
Participants in this group will complete weekly pacing sessions for 12 weeks. Pacing sessions will last about 30 minutes, as tolerated. Each participant will meet with a provider 'pacing coach' who has received study-specific education about PEM and how to create and manage pacing strategies for participants. Sessions include PEM symptom and trigger assessment; task, function and activity analysis; adaptations and modifications. |
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Otro: Usual Care
Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication. |
Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Frequency of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)
Periodo de tiempo: Baseline, week 12 (End Of Intervention, EOI)
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Symptom frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. |
Baseline, week 12 (End Of Intervention, EOI)
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Change in Severity of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)
Periodo de tiempo: Baseline, week 12 (EOI)
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Symptom severity is rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. |
Baseline, week 12 (EOI)
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Change in Duration of PEM Symptoms, as Measured by the Modified DePaul Symptom - Post-Exertional Malaise Questionnaire (mDSQ-PEM)
Periodo de tiempo: Baseline, week 12 (EOI)
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Ordinal categorical response: <=1 hour, 2-3 hours, 4-10 hours, 11-13 hours, 14-23 hours, >=24 hours. Reported as the number of participants who provided each response. |
Baseline, week 12 (EOI)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in PASC Symptoms, as Measured by the PROMIS-Cog Questionnaire
Periodo de tiempo: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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The PROMIS Short Form v.2.0 - Cognitive Function 8a (PROMIS-Cog) is the PROMIS Short Form to assess cognitive function and is a self-report, 8-item questionnaire targeting cognitive function in the past seven days. T-Scores in a healthy reference population have mean=50 and standard deviation = 10, with higher scores indicating higher functioning. |
Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Change in Quality of Life, as Measured by the PROMIS-29+2
Periodo de tiempo: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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The PROMIS-29+2 is used to calculate a preference score (PROPr) by the addition of two Cognitive Function Ability items. Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health). |
Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Change in Quality of Life, as Measured by the EQ-5D 5L
Periodo de tiempo: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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The EQ-5D is a standardized measure of health status. Mobility was measured on a scale from 1 (no problems in walking) to 5 (unable to walk). |
Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Change in Step Count (Physical Activity) as Measured by Actigraphy
Periodo de tiempo: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Actigraphy will be measured by Fitbit. Participant steps were considered valid from days where they wore the Fitbit at least 10 waking hours. Average steps were calculated from subjects with at least 5 consecutive days of valid data within a week window of their expected visit dates. |
Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Change in Physical Activity, as Measured by the PROMIS SF-Physical Function (PROMIS-PF)
Periodo de tiempo: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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The PROMIS Short Form v2.0 - Physical Function 8b (PROMIS-PF) consists of 8 items. The PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. T-Scores in a healthy reference population have mean = 50 and standard deviation = 10, with higher scores indicating higher functioning. |
Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Change in Orthostatic Hypotension, as Measured by the Modified Orthostatic Hypotension Questionnaire (mOHQ)
Periodo de tiempo: Screening, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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The Orthostatic Hypotension Questionnaire (OHQ) is a measure of orthostatic intolerance. The modified OHQ (mOHQ) measure used in this study includes a total of ten items related to daily activities and symptoms. The OHQ composite score ranges from 0 (no burden) to 10 (maximal burden). Higher scores are worse. The OHQ composite score includes 6 symptom items (OISA) and 4 daily activity items (OIDAS). |
Screening, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in PASC Symptoms, as Measured by the PASC Symptom Questionnaire
Periodo de tiempo: Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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The PASC Symptom Questionnaire is a 33-question survey for self-reporting multiple PASC-related symptoms across multiple systems. |
Baseline, week 6 (Middle of Intervention), week 12 (EOI), month 6 (EOS)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Gary M Felker, MD, Duke Clinical Research Institute
- Silla de estudio: Barry Make, MD, National Jewish Health
- Silla de estudio: Lucinda Bateman, MD, Bateman Horne Center
- Silla de estudio: Janna Friedly, MD, MPH, University of Washington
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos posinfecciosos
- COVID-19
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Infecciones del Tracto Respiratorio
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neumonía Viral
- Neumonía
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Síndrome post-agudo de COVID-19
- Actividad del motor
Otros números de identificación del estudio
- Pro00112409_B
- OT2HL156812 (Subvención/contrato del NIH de EE. UU.)
- NHLBI Grant to RTI (Otro número de subvención/financiamiento: RTI subcontracting with DCRI)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The summary of the results will be shared on the study website: https://recovercovid.org/
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .