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Exercise in Child Health

Study acronym: Project REACH
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later Jun 30, 2026 → Dec 31, 2027
See other at-risk trials from University of California, Irvine

Record History

  1. Notable Primary and study completion pushed from Jun 30, 2026 to Dec 31, 2027 Eligibility criteria expanded, about 23 words · Study description revised · Collaborators: details revised at 3 of 3 entries · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 23 words
    • Study description revised
    • Collaborators: details revised at 3 of 3 entries
    • Publications: details revised at 17 of 17 entries
  2. Notable Primary completion date: Jun 30, 2025 to Jun 30, 2026 Completion date: Jan 2026 to Jun 30, 2026 · Study arms: 4 to 5v7 Show 2 more changesShow less
    • Completion date: Jan 2026 to Jun 30, 2026
    • Study arms: 4 to 5
  3. Minor Primary completion date: Apr 2025 to Jun 30, 2025 Completion date: May 2025 to Jan 2026 · Site contact updatedv6 Show 2 more changesShow less
    • Completion date: May 2025 to Jan 2026
    • Site contact updated
  4. Notable Primary completion date: May 2024 to Apr 2025 Completion date: Jun 2024 to May 2025v5 Show 1 more changeShow less
    • Completion date: Jun 2024 to May 2025
  5. Minor Start date: Feb 24, 2022 to Nov 12, 2020 Collaborators revised (3)v4 Show 1 more changeShow less
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Primary completion date: Jun 2023 to May 2024v3
  2. Minor Start date changed from estimate of May 15, 2022 to Feb 24, 2022v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a cooperative investigation funded by the NIH. The project is a collaboration among three major NIH Clinical Translational Science Awardees: 1) UCI (lead site with its affiliate CHOC), 2) Northwestern University (with its affiliate Lurie Children's Hospital), and 3) USC (with its affiliate Children's Hospital of Los Angeles). There is an increasing number of children who, through medical advances, now survive diseases and conditions that were once fatal, but which remain chronic and debilitating. A major challenge to improve both the immediate and long term care and health of such children has been the gap in our understanding of how to assess the biological effects of exercise. Like otherwise healthy children, children with chronic diseases and disabilities want to be physically active. The challenge is to determine what constitutes safe and beneficial level of physical activity when the underlying disease or condition \[e.g., cystic fibrosis (CF) or sickle cell disease (SCD)\] imposes physiological constraints on exercise that are not present in otherwise healthy children. Current exercise testing protocols were based on studies of athletes and high performing healthy individuals and were designed to test limits of performance at very high-intensity, unphysiological, maximal effort. These approaches are not optimal for children and adolescents with disease and disability. This project (REACH-Revamping Exercise Assessment in Child Health) is designed to address this gap. Cohorts of children will be identified with two major genetic diseases (CF and SCD) and measure exercise responses annually as they progress from early puberty to mid or late puberty over a 3-4year period. In addition, in the light of the pandemic, a group of children will be added who were affected by SARS-CoV-2 and investigate their responses to exercise. SARS-CoV-2 has similar long-term symptoms than CF and SCD have. Novel approaches to assessing physiological responses to exercise using advanced data analytics will be examined in relation to metrics of habitual physical activity, circulating biomarkers of inflammation and growth, leukocyte gene expression, and the impact of the underlying CF, SCD or SARS-CoV-2 condition. The data from this study will help to develop a toolkit of innovative metrics for exercise testing that will be made available to the research and clinical community.
Trial Details
NCT Number NCT05359991
Lead Sponsor University of California, Irvine
Collaborators: Children's Hospital of Orange County, Children's Hospital Los Angeles, Ann & Robert H Lurie Children's Hospital of Chicago
Conditions Cystic Fibrosis, Sickle Cell Disease, SARS CoV 2 Infection
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov