- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02538900
Low InTensity Exercise Intervention in PAD (LITE)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Baptist, Tulane University
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
All participants will have PAD. PAD will be defined as follows. First, an ABI < or = 0.90 at the baseline study visit is a well-accepted standard for the diagnosis of PAD and will be an inclusion criterion. Second, people with an ABI of >0.90 and < or = 1.00 who experience a 20% ankle systolic pressure drop after the heel-rise test will also be included. Third, potential participants with an ABI > 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD who have ischemic symptoms during the six-minute walk and/or treadmill exercise stress test will be eligible. In addition to meeting a criterion for PAD, all participants must be symptomatic, defined by one of the following criteria:; a) ischemic leg symptoms (primarily assessed with the San Diego Claudication Questionnaire); b) report ischemic leg symptoms at the end of the six-minute walk; c) report ischemic leg symptoms at the end of the baseline treadmill stress test; d) walking impairment questionnaire results, e) interview with the potential participant about the presence and nature of leg symptoms during walking activity.
Exclusion Criteria:
- Above or below knee amputation, critical limb ischemia, wheelchair confinement, or foot ulcer.
- Individuals whose walking is limited by a condition other than PAD.
- > Class II NYHA heart failure or angina. Increase in angina, angina at rest, or abnormal baseline treadmill stress test.
- Major surgery including lower extremity revascularization or orthopedic surgery during the prior three months or anticipated in the next twelve months.
- Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen other than at night, or cancer (other than non-melanoma skin cancer) requiring treatment in the prior three years. Potential participants may still qualify if they have had treatment for early stage cancer in the previous three years and the prognosis is excellent.
- Mini-mental status examination score <23, dementia, or psychiatric illness including severe depression or anxiety. Investigator discretion may be used to allow some people with an MMSE below 23 to participate if the investigator determines there is another reason for their lower score, including lack of sufficient familiarity with the English language or lack of sufficient education to achieve a score of 23 or higher.
- Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention.
- Current or recent (within 3 months) participation in another clinical trial or cardiac rehabilitation. For a clinical trial of a stem cell or gene therapy intervention, potential participants will be potentially eligible immediately after the final study visit for the clinical trial, so long as long as at least six months has passed since the participant received their final treatment in the stem cell or gene therapy intervention. For a clinical trial involving open-label therapy in which the treatment is not related to functional performance and will not change during the LITE Trial, participants may still qualify for the LITE Trial based on investigator discretion.
- Individuals with PAD who have a history of lower extremity revascularization and have a normal ABI.
- Individuals who are not able to walk for exercise at a sufficiently slow pace to avoid ischemic leg symptoms.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Group 1
Low-intensity, self-paced walking exercise.
Home based exercise.
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Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I).
During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach.
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Experimental: Group 2
Standard high intensity, ischemic pain-inducing walking exercise.
Home based exercise.
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Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I).
During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach.
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Comparador activo: Group 3
Non-exercising attention control group.
Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise.
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Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention.
Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I).
These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers.
Topics include Medicare Part D, nutritional supplements, and cancer screening.
During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Six-minute Walk Distance
Periodo de tiempo: change from baseline to week 52
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In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible.
Distance covered in six minutes is recorded.
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change from baseline to week 52
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Six-minute Walk Distance
Periodo de tiempo: change from baseline to week 26
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In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible.
Distance covered in six minutes is recorded.
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change from baseline to week 26
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Maximal Treadmill Walking Time
Periodo de tiempo: change from baseline to week 52
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In the treadmill walking test, participants walk on either a gardner or modified gardner protocol until they stop the test.
Time walked is recorded
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change from baseline to week 52
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Physical Activity Levels
Periodo de tiempo: Change from baseline to week 52
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ActiGraph measured physical activity
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Change from baseline to week 52
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Walking Impairment Questionnaire (WIQ) Distance and Speed Score.
Periodo de tiempo: change from baseline to week 52
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The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed.
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change from baseline to week 52
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Health-related Quality of Life Measure
Periodo de tiempo: change from baseline to week 52
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The SF-36 physical functioning score will be used to measure quality of life.
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change from baseline to week 52
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Adherence to Intervention
Periodo de tiempo: from baseline to week 52
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Adherence is defined as the proportion achieving at least 80% of the prescribed exercise frequency and duration during the final month of the intervention.
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from baseline to week 52
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Change in Muscle Biopsy Measures of Mitochondrial Oxidative Metabolism and Oxidative Stress.
Periodo de tiempo: change from baseline to week 52
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Muscle tissue will be collected at baseline and follow up to measures Change in muscle biopsy measures of mitochondrial oxidative metabolism and oxidative stress.
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change from baseline to week 52
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Qualitative Assessment
Periodo de tiempo: At 52 week follow up
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We will use qualitative methods to explore participants' perceptions of the exercise interventions in the high and low-intensity exercise groups, respectively.
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At 52 week follow up
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Physical Activity Levels Over Seven Days
Periodo de tiempo: 26 week follow-up.
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ActiGraph
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26 week follow-up.
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WIQ Distance and Speed Score
Periodo de tiempo: 26 week follow-up
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The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed.
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26 week follow-up
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Health Related Quality of Life
Periodo de tiempo: 26 weeks
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SF-36 physical functioning score.
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26 weeks
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Adherence to Assigned Intervention
Periodo de tiempo: 26 weeks.
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Adherence is defined as the proportion achieving at least 80% of the prescribed exercise frequency and duration during the final month of the intervention.
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26 weeks.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mary McDermott, MD, Northwestern University
Publicaciones y enlaces útiles
Publicaciones Generales
- Hammond MM, Spring B, Rejeski WJ, Sufit R, Criqui MH, Tian L, Zhao L, Xu S, Kibbe MR, Leeuwenburgh C, Manini T, Forman DE, Treat-Jacobson D, Polonsky TS, Bazzano L, Ferrucci L, Guralnik J, Lloyd-Jones DM, McDermott MM. Effects of Walking Exercise at a Pace With Versus Without Ischemic Leg Symptoms on Functional Performance Measures in People With Lower Extremity Peripheral Artery Disease: The LITE Randomized Clinical Trial. J Am Heart Assoc. 2022 Aug 2;11(15):e025063. doi: 10.1161/JAHA.121.025063. Epub 2022 Jul 27.
- Slysz JT, Rejeski WJ, Treat-Jacobson D, Bazzano LA, Forman DE, Manini TM, Criqui MH, Tian L, Zhao L, Zhang D, Guralnik JM, Ferrucci L, Kibbe MR, Polonsky TS, Spring B, Sufit R, Leeuwenburgh C, McDermott MM. Sustained physical activity in peripheral artery disease: Associations with disease severity, functional performance, health-related quality of life, and subsequent serious adverse events in the LITE randomized clinical trial. Vasc Med. 2021 Oct;26(5):497-506. doi: 10.1177/1358863X21989430. Epub 2021 Apr 8.
- McDermott MM, Spring B, Tian L, Treat-Jacobson D, Ferrucci L, Lloyd-Jones D, Zhao L, Polonsky T, Kibbe MR, Bazzano L, Guralnik JM, Forman DE, Rego A, Zhang D, Domanchuk K, Leeuwenburgh C, Sufit R, Smith B, Manini T, Criqui MH, Rejeski WJ. Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial. JAMA. 2021 Apr 6;325(13):1266-1276. doi: 10.1001/jama.2021.2536.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STU00105855
- 1R01HL122846-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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