Sickle Cell Disease Trial, Recruiting NCT05359991 Sponsor: University of California, Irvine Condition: Sickle Cell Disease
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Sickle Cell Disease Trial, Recruiting

NCT05359991
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For young people with Sickle Cell Disease (SCD):

  • People between Tanner stages 1–5 (roughly ages 10–17) with a diagnosis of sickle cell disease in any relevant form
  • People considered to be in relatively good health for someone with SCD, with no SCD complications that a doctor considers would make participation unsafe
  • People with no other illness or disability that would prevent participation in physical activity
  • People whose doctor has given permission to take part in a cardiopulmonary exercise test (a supervised breathing and fitness test)
  • People whose body weight falls within the typical range for their age and condition

For young people with Cystic Fibrosis (CF):

  • People between Tanner stages 1–5 (roughly ages 10–17) with a confirmed CF diagnosis, either through two CF-related gene mutations and/or a sweat chloride test result above 60 mmol/l
  • People considered to be in relatively good health for someone with CF, with no CF complications — such as severe lung bleeding or significant lung blood pressure problems — that a doctor considers would make participation unsafe
  • People whose body weight falls within the typical range for their age and condition
  • People with no other illness or disability that would prevent participation in physical activity

For healthy comparison participants:

  • People between Tanner stages 1–5 (roughly ages 10–17) who are considered to be in good health following a health check by a primary care provider or trial staff
  • People whose body weight and physical activity levels fall within the typical range for their age
  • People with no illness or disability that would prevent participation in physical activity

For participants who have had a COVID-19 (SARS-CoV-2) infection:

  • People between Tanner stages 1–5 (roughly ages 10–17) with a documented COVID-19 infection
  • People whose primary care provider or trial medical staff consider to be capable of doing exercise

Who may not be able to join:

For young people with Sickle Cell Disease:

  • People currently receiving regular monthly blood transfusions
  • People with other conditions that prevent exercise, such as a neurological movement disorder, heart disease, or any similar condition
  • People currently being treated for substance or alcohol misuse

For young people with Cystic Fibrosis:

  • People whose lung function (FEV1) is below 40% of the expected level for their age and size
  • People with a current infection with specific bacteria — Burkholderia cenocepacia or Mycobacterium abscessus (confirm with trial site)
  • People with other conditions that prevent exercise, such as a neurological movement disorder, heart disease, or any similar condition
  • People currently being treated for substance or alcohol misuse

For healthy comparison participants:

  • People currently being treated for substance or alcohol misuse, or who are taking ongoing regular medications
  • People considered unsuitable for exercise by trial staff

For COVID-19 comparison participants:

  • People currently being treated for substance or alcohol misuse, or who are taking ongoing regular medications
  • People considered unsuitable for exercise by trial staff

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: (714) 456-8248

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University of California, Irvine
Registry
ClinicalTrials.gov
Start date
12 November 2020
Est. completion
30 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Gas Exchange Variables; Whole Body Lean Mass; Physical Activity; Biomarkers; Gene Expression; Gas Exchange Variables; Gas Exchange Variables; Gas Exchange Variables; Gas Exchange Variables; Gas Exchange Variables; Gas Exchange Variables; Fat Mass; % Body Fat; Whole Body Bone Mineral Content; Whole Body Bone Mineral Density; Biomarkers; Biomarkers; Biomarkers; Biomarkers; Biomarkers; Biomarkers; Biomarkers; Gene Expression; Gene Expression

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov