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HEART Camp Connect: promoción del ejercicio en adultos con insuficiencia cardíaca con fracción de eyección conservada

5 de noviembre de 2026 actualizado por: University of Nebraska

HEART (ejercicio de insuficiencia cardíaca y entrenamiento de resistencia) Camp Connect: promoción de la adherencia al ejercicio en adultos con insuficiencia cardíaca con fracción de eyección preservada

The goal of this study is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise. Investigators want to see if meeting with a coach in person or by video conference will help these patients exercise, feel better, and change markers in their blood. Participants will be randomly placed in one of three groups for 18 months. All groups will have access to a fitness center and be given a watch and heart rate monitor to wear during exercise. The usual care group (control group) will have access to exercise videos via the medical fitness center and will not meet with a coach. The HEART Camp group will exercise and meet with their coach in-person at the medical fitness center. The HEART Camp Connect group will have access to exercise videos via the medical fitness center and will meet with their coach via videoconferencing. All participants will take part in an exercise test and study training prior to being randomized. At four data collection time points, participants will wear an activity monitor for 7 days each, have their blood drawn, and answer questions related to heart failure and exercise. Participants will also wear a heart rate monitor when they exercise and fill out a daily exercise diary.

Descripción general del estudio

Descripción detallada

The overall objectives for this study are to: (a) test the efficacy of virtual and in-person exercise interventions to promote long-term adherence to exercise; (b) determine a benchmark of exercise minutes that reaches a minimal clinically important difference in heart failure related health status and drives improvements in physical function, inflammatory markers, and patient-reported outcomes; (c) identify interventional mechanisms, interim clinical events and prognostic indicators of heart failure with preserved ejection fraction (HFpEF) that mediate adherence; (d) assess delivery method and related cost of the intervention to support translation and scalability. To meet these objectives, investigators propose a three-group, 2-2-1 randomized repeated measures experimental design with 4 data collection points [baseline, 6, 12, and 18 months to compare HEART Camp, HEART Camp Connect, and virtual enhanced usual care (EUC).

This study begins with the cardiopulmonary exercise testing (CPET) . The CPET is used to develop an exercise prescription and ensure participant safety and readiness for exercise. Participants who have completed a CPET within 6 months of enrollment with no changes in medications will not repeat the test. Any participants who exhibit potential safety concerns during CPET (e.g. cardiac arrhythmias, balance instability) will be evaluated by a trained providers, prior to continuing in the study. Those deemed unsafe to exercise will be withdrawn. After the CPET, participants will take part in the run-in period with 3 monitored sessions in cardiac rehabilitation and study orientation. All participants will be oriented during a one-time in-person training to familiarize them with the 1) Either in-person Engage center or Engage virtual platform via the HEART Camp You Tube channel; 2) All monitoring devices (Polar watch and Polar heart rate monitor, Actigraph, rating of perceived exertion scale, and exercise diary); and 3) Private HEART Camp You Tube channel where they can view investigator-developed educational videos specific to HFpEF and virtual exercise content. Participants who do not have a smart device with internet capability or have an insufficient data plan will be given a tablet with a wireless data plan for study use.

After randomization, participants in the intervention groups (HEART Camp Connect and HEART Camp) meet with a coach for the first 12 months of the study. The HEART Camp group will meet in-person at the medical fitness center with their coach. The HEART Camp Connect group will meet virtually, over videoconference. To improve the scalability of this intervention, investigators will taper coaching sessions according to the following schedule: Months 1-3 weekly, 1-on-1 coaching for 30 minutes; Months 4-12 1-on-1 coaching is reduced to 15 minute sessions every other week. On alternate weeks, participants will attend a 1-hour group-based exercise training and coaching. During these sessions, the coach will meet with 4-6 participants at once. One half of the class will be an exercise training session and the other half will be a question/answer session for participants to talk to the coach and each other about strategies for exercise. After 12 months, coaching (both intervention groups) and motivational messages (HEART Camp Connect only) will stop and participants will be expected to self-regulate exercise in months 13-18.

Participants will be asked to build up to 150 minutes of moderate-intensity exercise weekly. During exercise sessions, participants will be asked to wear their study-provided watch and heart rate monitor and keep a daily exercise diary.

Participants will meet with research personnel at 4 times during the study for data collection including where they will have their blood drawn and complete a 6 minute walk test. At these data collection time points, participants will also wear an activity monitor for 7 days/nights and complete surveys related to their heart failure and exercise.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

300

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Windy W Alonso, PhD
  • Número de teléfono: 402-559-8342
  • Correo electrónico: windy.alonso@unmc.edu

Ubicaciones de estudio

    • Michigan
      • Detroit, Michigan, Estados Unidos, 49201
        • Reclutamiento
        • Henry Ford Health System
        • Contacto:
        • Contacto:
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68198-5330
        • Reclutamiento
        • University of Nebraska Medical Center
        • Contacto:
          • Bunny Pozehl, PhD, RN
          • Número de teléfono: 402-559-8342
          • Correo electrónico: bpozehl@unmc.edu
        • Contacto:
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosis of heart failure with an ejection fraction greater than or equal to 50
  • Echocardiogram in prior 24 months
  • Stable pharmacologic therapy in the past 30 days
  • Any of the following evidence to confirm HFpEF - Score< 6 on Heavy Hypertensive Atrial Fibrillation, Pulmonary Hypertension, Elder, Filling Pressure algorithm, invasive hemodynamic evidence of HFpEF(i.e., elevated pulmonary wedge pressure), or a confirmed clinical diagnosis of HFpEF

Exclusion Criteria:

  • Life-limiting illness precluding study completion
  • Clinical evidence of decompensated heart failure
  • Unstable angina or marked shortness of breath on exertion at less than 2 metabolic equivalents
  • Myocardial infarction, coronary artery bypass graft, or biventricular pacemaker in prior 6 weeks
  • Orthopedic or neuromuscular disorders preventing aerobic exercise
  • Cardiopulmonary exercise test results that preclude safe exercise
  • Unwilling/unable to complete pre-randomization procedures
  • Pregnancy
  • Implantable cardioverter defibrillator

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: HEART Camp

Participants in the HEART Camp group will be provided paid, in-person access to the medical fitness center and in-person coaching by a trained coach.

Participants will meet with an in-person coach at the medical fitness center: Months 1-3 weekly for 30 minutes; Months 4-12 every other week for 15 minutes (on alternate weeks, participants will attend a 1-hour group-based exercise training and coaching).

Experimental: HEART Camp Connect

Participants in the HEART Camp Connect group will be provided paid, virtual access to the medical fitness center and virtual coaching by a trained coach via videoconference. Participants will also receive automated, asynchronous motivational electronic messaging if they are below the weekly adherence threshold.

Participants will meet with a virtual coach from the medical fitness center via videoconferencing: Months 1-3 weekly for 30 minutes; Months 4-12 every other week for 15 minutes (on alternate weeks, participants will attend a virtual 1-hour group-based exercise training and coaching session via videoconferencing).

Sin intervención: Enhanced Usual Care

Participants in the Enhanced Usual Care group will be provided paid virtual access to the medical fitness center and virtual availability of the medical fitness center staff and study personnel for participant-initiated questions.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Exercise Adherence
Periodo de tiempo: 6 months

Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.

6 months
Exercise Adherence
Periodo de tiempo: 12 months

Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.

12 months
Exercise Adherence
Periodo de tiempo: 18 months

Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor.

18 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HF-related Health Status
Periodo de tiempo: Baseline

Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status.

Baseline
HF-related Health Status
Periodo de tiempo: 6 months

Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status.

6 months
HF-related Health Status
Periodo de tiempo: 12 months

Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status.

12 months
HF-related Health Status
Periodo de tiempo: 18 months

Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status.

18 months
Physical Function
Periodo de tiempo: Baseline

Physical function will be measured by distance in meters completed on the 6 minute walk test.

Baseline
Physical Function
Periodo de tiempo: 6 months

Physical function will be measured by distance in meters completed on the 6 minute walk test.

6 months
Physical Function
Periodo de tiempo: 12 months

Physical function will be measured by distance in meters completed on the 6 minute walk test.

12 months
Physical Function
Periodo de tiempo: 18 months

Physical function will be measured by distance in meters completed on the 6 minute walk test.

18 months
Physical Activity
Periodo de tiempo: Baseline

Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.

Baseline
Physical Activity
Periodo de tiempo: 6 months

Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.

6 months
Physical Activity
Periodo de tiempo: 12 months

Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.

12 months
Physical Activity
Periodo de tiempo: 18 months

Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights.

18 months
Dyspnea Severity
Periodo de tiempo: Baseline

Patient-Reported Outcomes Measurement Information System (PROMIS)-Dyspnea Severity 10a, assessing severity of shortness of breath in response to different activities over the prior 7-day period. 10 items are assessed on a 4-point Likert scale with raw scores ranging from 0-30. Higher scores indicate greater perceived dyspnea.

Baseline
Dyspnea Severity
Periodo de tiempo: 6 months

Patient-Reported Outcomes Measurement Information System (PROMIS)-Dyspnea Severity 10a, assessing severity of shortness of breath in response to different activities over the prior 7-day period. 10 items are assessed on a 4-point Likert scale with raw scores ranging from 0-30. Higher scores indicate greater perceived dyspnea.

6 months
Dyspnea Severity
Periodo de tiempo: 12 months

Patient-Reported Outcomes Measurement Information System (PROMIS)-Dyspnea Severity 10a, assessing severity of shortness of breath in response to different activities over the prior 7-day period. 10 items are assessed on a 4-point Likert scale with raw scores ranging from 0-30. Higher scores indicate greater perceived dyspnea.

12 months
Dyspnea Severity
Periodo de tiempo: 18 months

Patient-Reported Outcomes Measurement Information System (PROMIS)-Dyspnea Severity 10a, assessing severity of shortness of breath in response to different activities over the prior 7-day period. 10 items are assessed on a 4-point Likert scale with raw scores ranging from 0-30. Higher scores indicate greater perceived dyspnea.

18 months
Global Symptoms
Periodo de tiempo: Baseline

PROMIS-29 Profile v2.1 assessing physical function, anxiety, depression, fatigue, sleep disturbances, satisfaction with social role, pain impact, and pain intensity. Pain intensity is assessed using a single 0-10 numeric rating, The 7 health domains are measured using 4 items per domain that are assessed on a 5-point Likert scale. Each domain is scored separately with raw scores ranging from 4-20, higher scores indicate worse symptomatology.

Baseline
Global Symptoms
Periodo de tiempo: 6 months

PROMIS-29 Profile v2.1 assessing physical function, anxiety, depression, fatigue, sleep disturbances, satisfaction with social role, pain impact, and pain intensity. Pain intensity is assessed using a single 0-10 numeric rating, The 7 health domains are measured using 4 items per domain that are assessed on a 5-point Likert scale. Each domain is scored separately with raw scores ranging from 4-20, higher scores indicate worse symptomatology.

6 months
Global Symptoms
Periodo de tiempo: 12 months

PROMIS-29 Profile v2.1 assessing physical function, anxiety, depression, fatigue, sleep disturbances, satisfaction with social role, pain impact, and pain intensity. Pain intensity is assessed using a single 0-10 numeric rating, The 7 health domains are measured using 4 items per domain that are assessed on a 5-point Likert scale. Each domain is scored separately with raw scores ranging from 4-20, higher scores indicate worse symptomatology.

12 months
Global Symptoms
Periodo de tiempo: 18 months

PROMIS-29 Profile v2.1 assessing physical function, anxiety, depression, fatigue, sleep disturbances, satisfaction with social role, pain impact, and pain intensity. Pain intensity is assessed using a single 0-10 numeric rating, The 7 health domains are measured using 4 items per domain that are assessed on a 5-point Likert scale. Each domain is scored separately with raw scores ranging from 4-20, higher scores indicate worse symptomatology.

18 months
Health-related Quality of Life
Periodo de tiempo: Baseline

Euro Qual (EQ)-5 Dimension, assessing the five dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 5 items are assessed on a 5-point Likert scale and a summary index with a maximum score of 1 is derived from the 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state.

Baseline
Health-related Quality of Life
Periodo de tiempo: 6 months

Euro Qual (EQ)-5 Dimension, assessing the five dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 5 items are assessed on a 5-point Likert scale and a summary index with a maximum score of 1 is derived from the 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state.

6 months
Health-related Quality of Life
Periodo de tiempo: 12 months

Euro Qual (EQ)-5 Dimension, assessing the five dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 5 items are assessed on a 5-point Likert scale and a summary index with a maximum score of 1 is derived from the 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state.

12 months
Health-related Quality of Life
Periodo de tiempo: 18 months

Euro Qual (EQ)-5 Dimension, assessing the five dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 5 items are assessed on a 5-point Likert scale and a summary index with a maximum score of 1 is derived from the 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state.

18 months
Health Status
Periodo de tiempo: Baseline

Euro Qual (EQ)-Visual Analog Scale, Participants rate their perceived health status on a scale of 0-100 with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state

Baseline
Health Status
Periodo de tiempo: 6 months

Euro Qual (EQ)-Visual Analog Scale, Participants rate their perceived health status on a scale of 0-100 with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state

6 months
Health Status
Periodo de tiempo: 12 months

Euro Qual (EQ)-Visual Analog Scale, Participants rate their perceived health status on a scale of 0-100 with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state

12 months
Health Status
Periodo de tiempo: 18 months

Euro Qual (EQ)-Visual Analog Scale, Participants rate their perceived health status on a scale of 0-100 with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state

18 months
C-reactive protein (CRP)
Periodo de tiempo: Baseline

CRP will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 1.33 Max 49,600

Baseline
C-reactive protein
Periodo de tiempo: 12 months

CRP will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 1.33 Max 49,600

12 months
Interleukin 1-Beta (IL1-beta)
Periodo de tiempo: Baseline

IL1-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.05 Max 375

Baseline
Interleukin 1-Beta
Periodo de tiempo: 12 months

IL1-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.05 Max 375

12 months
Interleukin 1-Alpha (IL1-alpha)
Periodo de tiempo: Baseline

IL1-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.09 Max 278

Baseline
Interleukin 1-Alpha
Periodo de tiempo: 12 months

IL1-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.09 Max 278

12 months
Tumor Necrosis Factor-alpha (TNF-alpha)
Periodo de tiempo: Baseline

TNF-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.04 Max 248

Baseline
Tumor Necrosis Factor-alpha
Periodo de tiempo: 12 months

TNF-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.04 Max 248

12 months
Tumor Necrosis Factor-beta
Periodo de tiempo: Baseline

TNF-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.08 Max 458

Baseline
Tumor Necrosis Factor-beta
Periodo de tiempo: 12 months

TNF-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.08 Max 458

12 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Self-Efficacy
Periodo de tiempo: Baseline

Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior. 13 items rated on a 100-point scale (each statement is scored on a 100-point percentage scale with 10-point increments.) Higher score values indicated greater perceived self-efficacy.

Baseline
Self-Efficacy
Periodo de tiempo: 6 months

Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior. 13 items rated on a 100-point scale (each statement is scored on a 100-point percentage scale with 10-point increments.) Higher score values indicated greater perceived self-efficacy.

6 months
Self-Efficacy
Periodo de tiempo: 12 months

Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior. 13 items rated on a 100-point scale (each statement is scored on a 100-point percentage scale with 10-point increments.) Higher score values indicated greater perceived self-efficacy.

12 months
Self-Efficacy
Periodo de tiempo: 18 months

Barriers Self-Efficacy Scale, assessing self-efficacy or confidence in exercising behavior. 13 items rated on a 100-point scale (each statement is scored on a 100-point percentage scale with 10-point increments.) Higher score values indicated greater perceived self-efficacy.

18 months
Outcome Expectations
Periodo de tiempo: Baseline

Multi-Dimensional Outcome Expectation for Exercise, 15-items assessed on a 5-point Likert scale from 1 (strongly disagree to 5 (strongly agree), measuring 3 domains of outcome expectations for exercise. High scores indicate a higher level of outcome expectations for exercise.

Baseline
Outcome Expectations
Periodo de tiempo: 6 months

Multi-Dimensional Outcome Expectation for Exercise, 15-items assessed on a 5-point Likert scale from 1 (strongly disagree to 5 (strongly agree), measuring 3 domains of outcome expectations for exercise. High scores indicate a higher level of outcome expectations for exercise.

6 months
Outcome Expectations
Periodo de tiempo: 12 months

Multi-Dimensional Outcome Expectation for Exercise, 15-items assessed on a 5-point Likert scale from 1 (strongly disagree to 5 (strongly agree), measuring 3 domains of outcome expectations for exercise. High scores indicate a higher level of outcome expectations for exercise.

12 months
Outcome Expectations
Periodo de tiempo: 18 months

Multi-Dimensional Outcome Expectation for Exercise, 15-items assessed on a 5-point Likert scale from 1 (strongly disagree to 5 (strongly agree), measuring 3 domains of outcome expectations for exercise. High scores indicate a higher level of outcome expectations for exercise.

18 months
Attitudes toward exercise
Periodo de tiempo: Baseline

Attitudes Toward Physical Activity/Exercise Scale, 14 items assessed on a 5-point Likert scale from 1 (disagree a lot) to 5 (agree a lot), values range from 14-70 with higher scores indicating a more positive attitude.

Baseline
Attitudes toward exercise
Periodo de tiempo: 6 months

Attitudes Toward Physical Activity/Exercise Scale, 14 items assessed on a 5-point Likert scale from 1 (disagree a lot) to 5 (agree a lot), values range from 14-70 with higher scores indicating a more positive attitude.

6 months
Attitudes toward exercise
Periodo de tiempo: 12 months

Attitudes Toward Physical Activity/Exercise Scale, 14 items assessed on a 5-point Likert scale from 1 (disagree a lot) to 5 (agree a lot), values range from 14-70 with higher scores indicating a more positive attitude.

12 months
Attitudes toward exercise
Periodo de tiempo: 18 months

Attitudes Toward Physical Activity/Exercise Scale, 14 items assessed on a 5-point Likert scale from 1 (disagree a lot) to 5 (agree a lot), values range from 14-70 with higher scores indicating a more positive attitude.

18 months
Self-Regulation
Periodo de tiempo: Baseline

Physical Activity Self-Regulation Scale, 12 items assessed on a 5-point Likert scale from 1 (never) to 5 (very often), scores range from 12-60, with higher scores indicating greater use of self-regulatory strategies for physical activity.

Baseline
Self-Regulation
Periodo de tiempo: 6 months

Physical Activity Self-Regulation Scale, 12 items assessed on a 5-point Likert scale from 1 (never) to 5 (very often), scores range from 12-60, with higher scores indicating greater use of self-regulatory strategies for physical activity.

6 months
Self-Regulation
Periodo de tiempo: 12 months

Physical Activity Self-Regulation Scale, 12 items assessed on a 5-point Likert scale from 1 (never) to 5 (very often), scores range from 12-60, with higher scores indicating greater use of self-regulatory strategies for physical activity.

12 months
Self-Regulation
Periodo de tiempo: 18 months

Physical Activity Self-Regulation Scale, 12 items assessed on a 5-point Likert scale from 1 (never) to 5 (very often), scores range from 12-60, with higher scores indicating greater use of self-regulatory strategies for physical activity.

18 months
Informational Support
Periodo de tiempo: Baseline

PROMIS Informational Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived informational support.

Baseline
Informational Support
Periodo de tiempo: 6 months

PROMIS Informational Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived informational support.

6 months
Informational Support
Periodo de tiempo: 12 months

PROMIS Informational Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived informational support.

12 months
Informational Support
Periodo de tiempo: 18 months

PROMIS Informational Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived informational support.

18 months
Instrumental Support
Periodo de tiempo: Baseline

PROMIS Instrumental Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived instrumental support.

Baseline
Instrumental Support
Periodo de tiempo: 6 months

PROMIS Instrumental Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived instrumental support.

6 months
Instrumental Support
Periodo de tiempo: 12 months

PROMIS Instrumental Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived instrumental support.

12 months
Instrumental Support
Periodo de tiempo: 18 months

PROMIS Instrumental Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating greater perceived instrumental support.

18 months
Social Isolation
Periodo de tiempo: Baseline

PROMIS Social Isolation Short Form 4a, 4 items assessed on a Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating a higher perceived social isolation.

Baseline
Social Isolation
Periodo de tiempo: 6 months

PROMIS Social Isolation Short Form 4a, 4 items assessed on a Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating a higher perceived social isolation.

6 months
Social Isolation
Periodo de tiempo: 12 months

PROMIS Social Isolation Short Form 4a, 4 items assessed on a Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating a higher perceived social isolation.

12 months
Social Isolation
Periodo de tiempo: 18 months

PROMIS Social Isolation Short Form 4a, 4 items assessed on a Likert scale from 1 (never) to 5 (always) with raw scores ranging from 4-20, and higher scores indicating a higher perceived social isolation.

18 months
Emotional Support
Periodo de tiempo: Baseline

PROMIS Emotional Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always), with raw scores between 4-20, and higher scores indicating greater perceived emotional support.

Baseline
Emotional Support
Periodo de tiempo: 6 months

PROMIS Emotional Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always), with raw scores between 4-20, and higher scores indicating greater perceived emotional support.

6 months
Emotional Support
Periodo de tiempo: 12 months

PROMIS Emotional Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always), with raw scores between 4-20, and higher scores indicating greater perceived emotional support.

12 months
Emotional Support
Periodo de tiempo: 18 months

PROMIS Emotional Support Short Form 4a, 4 items assessed on a 5-point Likert scale from 1 (never) to 5 (always), with raw scores between 4-20, and higher scores indicating greater perceived emotional support.

18 months
Types of Physical Activity
Periodo de tiempo: Baseline

International Physical Activity Questionnaire, 4-item questionnaire, 3 of the items have 1 possible subsequent item. Answers are related to days per week and hours/minutes per day respondents perform an activity.

Baseline
Types of Physical Activity
Periodo de tiempo: 6 months

International Physical Activity Questionnaire, 4-item questionnaire, 3 of the items have 1 possible subsequent item. Answers are related to days per week and hours/minutes per day respondents perform an activity.

6 months
Types of Physical Activity
Periodo de tiempo: 12 months

International Physical Activity Questionnaire, 4-item questionnaire, 3 of the items have 1 possible subsequent item. Answers are related to days per week and hours/minutes per day respondents perform an activity.

12 months
Types of Physical Activity
Periodo de tiempo: 18 months

International Physical Activity Questionnaire, 4-item questionnaire, 3 of the items have 1 possible subsequent item. Answers are related to days per week and hours/minutes per day respondents perform an activity.

18 months
Fatigue
Periodo de tiempo: Baseline

Multidimensional Fatigue Symptom Inventory - Short Form, 30 items assess on a 5-point Likert scale from 0 (not at all) to 4 (extremely), possible values range from -24-96 with higher scores indicating a higher level of fatigue.

Baseline
Fatigue
Periodo de tiempo: 6 months

Multidimensional Fatigue Symptom Inventory - Short Form, 30 items assess on a 5-point Likert scale from 0 (not at all) to 4 (extremely), possible values range from -24-96 with higher scores indicating a higher level of fatigue.

6 months
Fatigue
Periodo de tiempo: 12 months

Multidimensional Fatigue Symptom Inventory - Short Form, 30 items assess on a 5-point Likert scale from 0 (not at all) to 4 (extremely), possible values range from -24-96 with higher scores indicating a higher level of fatigue.

12 months
Fatigue
Periodo de tiempo: 18 months

Multidimensional Fatigue Symptom Inventory - Short Form, 30 items assess on a 5-point Likert scale from 0 (not at all) to 4 (extremely), possible values range from -24-96 with higher scores indicating a higher level of fatigue.

18 months
Cognitive Assessment
Periodo de tiempo: Baseline

Montreal Cognitive Assessment, 12 items measuring 7 cognitive domains, scores range from 0-30, with higher scores indicating better cognitive function.

Baseline
Cognitive Assessment
Periodo de tiempo: 6 months

Montreal Cognitive Assessment, 12 items measuring 7 cognitive domains, scores range from 0-30, with higher scores indicating better cognitive function.

6 months
Cognitive Assessment
Periodo de tiempo: 12 months

Montreal Cognitive Assessment, 12 items measuring 7 cognitive domains, scores range from 0-30, with higher scores indicating better cognitive function.

12 months
Cognitive Assessment
Periodo de tiempo: 18 months

Montreal Cognitive Assessment, 12 items measuring 7 cognitive domains, scores range from 0-30, with higher scores indicating better cognitive function.

18 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Windy W Alonso, PhD, University of Virginia
  • Investigador principal: Bunny Pozehl, PhD, University of Nebraska

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de noviembre de 2023

Finalización primaria (Estimado)

1 de febrero de 2028

Finalización del estudio (Estimado)

1 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

2 de marzo de 2023

Primero enviado que cumplió con los criterios de control de calidad

13 de marzo de 2023

Publicado por primera vez (Actual)

27 de marzo de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Data will be available in the NHLBI Data Repository under the standard procedures utilized by NHLBI to allow others access to the data. All data from baseline, months 6, 12 and 18 will be provided. Procedural-based data such as the cardiopulmonary exercise test results and the heart rate monitor data will also be provided.

Marco de tiempo para compartir IPD

Data will be available beginning 9 months after the publication of primary outcome results.

Criterios de acceso compartido de IPD

Researchers that desire access to data from this study will be required to provide a methodologically sound proposal and comply with the standards outlined in the NHLBI data repository.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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