NCT07071324Recruiting
CF Wellness Program
CF Wellness Program: ORBIT Phase 2 Pilot RCT
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
This study is a pilot randomized control trial (RCT; N=80) comparing the Cystic Fibrosis Wellness Program (CFWP) to usual care (UC) to evaluate (1) Intervention Adherence (completion of the CFWP Coaching Sessions) (2) Study Retention (completion of the Week 15 assessment) and (3) Data Quality (valid daytime and nighttime fitness tracker data). A secondary aim is to gather preliminary data to determine if the CFWP has a clinically significant signal over usual care to improve fatigue, sleep, and physical activity (PA) and reduce sedentary behavior.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 8 Jul 2025
- Start date
- 3 Feb 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Johns Hopkins University
- Diseases
- Cystic fibrosis
- NCT number
- NCT07071324
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 3 Feb 2026 to the primary completion date, 30 Jun 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Pulmonary exacerbation (physician determined and may include oral antibiotics, IV antibiotics, hospitalization) ±14 days of enrollment
- Pregnant or \<6 months post-partum (self-reported)
- Contraindication to light physical activity (as determined by the treating physician and may include pulmonary, cardiovascular, or musculoskeletal contraindications)
- Participated in the CFWP Feasibility Study
- Currently enrolled in another interventional trial
- Unavailable to complete coaching sessions within the study timeframe
Who the study is looking for
- ≥18 years old
- Documentation of CF diagnosis in the medical record
- Score of \>4 on the Fatigue Severity Scale
- Access to a smartphone, tablet, and/or computer with access to internet
- Ability to understand/read/speak English
- Receives CF care at a participating CF Center
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| National Jewish Health Coordinator of this site? Confirm its status | Denver | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.