Last reviewed · How we verify
NCT04279730: PROMOD
Fatigue and Physical Performance During Pulmonary Rehabilitation
trial in Chronic Obstructive Pulmonary Disease in 96 participants. Completed in 9 April 2021.
13 March 2021
Quick facts
| Lead sponsor | 5 Santé |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 96 |
| Start date | 15 February 2020 |
| Primary completion | 13 March 2021 |
| Estimated completion | 9 April 2021 |
| Sites | 3 locations across France |
Conditions studied
- Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →
Sponsor
5 Santé
Who can join
Adults 40 to 80, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with COPD benefit from pulmonary rehabilitation (PR), but a ceiling effect of performance (ie. absence of additional exercise tolerance increase) is observed in 80% of patients from only 20 sessions. An imbalance between intensity, duration and frequency of PR sessions, leading to fatigue development in the course of the PR, could explain this ceiling effect. However, previous studies having evaluated the impact of a PR program on fatigue scores reported either a decrease or no changing, but never an increase. To date, no study has evaluated intermediate variations of fatigue score during a PR program, but were limited to a pre-post PR assessment. Therefore, fatigue fluctuations during PR are unknown. Furthermore, most studies had only unidimensional fatigue assessment. Since fatigue is a multifactorial and a multidimensional process, it cannot be accurately estimated through a unique assessment. Given that most of COPD patients do not increase their exercise tolerance from 20 PR sessions, the investigators hypothesize a significant increase of multidimensional fatigue score between the 1st and the 20th PR session during an inpatient rehabilitation program lasting 4 weeks (40 sessions).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04279730
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07418736 — A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease · Phase 2 · recruiting
- NCT07069829 — Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo · recruiting
Other 5 Santé trials
Trials by the same sponsor.
- NCT04010825 — Impact of Hypnosis Intervention on the Emotional Dimension of Dyspnea in Patients With COPD. · NA · completed
- NCT03807258 — Functional Implication of Corpus Callosum in Voluntary Strength in COPD Patients · NA · completed
- NCT03368703 — Physiopathology of Lower Cortical Activation in COPD Patients: Contribution of Cortical Neuromodulation · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04279730 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by 5 Santé
- Last refreshed: 14 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04279730.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing