Chronic Obstructive Pulmonary DiseasePROMODNCT04279730
Fatigue and Physical Performance During Pulmonary Rehabilitation
An observational study of Chronic Obstructive Pulmonary Disease, run by 5 Santé at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 96 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Feb 2020to 9 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients admited for an inpatient PR program at one of the three following pulmonary rehabilitation center will be consecutively recruiting: * Clinique du Souffle La Vallonie (Lodève, France) * Clinique du Souffle La Solane (Osseja, France) * Clinique du Souffle Les Clarines (Riom-es-Montagnes, France)
Who may be able to join
- Patients admited for a 4-weeks inpatient pulmonary rehabilitation program
- With a confirmed diagnosis of COPD
Who cannot join
- Severe or unstable heart disease
- Orthopedic, neurologic or psychatric comorbities
- Recent exacerbation (<4 weeks)
Trial locations and contacts
3 sites in 1 country.
France3 sites
Clinique du Souffle La Vallonie
Lodève, 34700
Clinique du Souffle La Solane
Osséja, 66340
Clinique du Souffle Les Clarines
Riom-ès-Montagnes, 15400
About this study
Official title: Impact of Fatigue on Physical Performance During a Pulmonary Rehabilitation Program in Patients With COPD
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).
Read the detailed description
Exercise tolerance is an important predictor of health status in patients with chronic obstructive pulmonary disease (COPD). A reduced 6-min walking distance is associated with an increased mortality risk in these patients. Pulmonary rehabilitation (PR) is one of the most efficient strategy to counterac this effect. Patients improving their exercise tolerance after a PR program have a reduced mortality risk. However, exercise tolerance improvement is not systematic after PR, since up to 1/3 of patients do not respond to the intervention. In addition, PR's effects are limited, with a ceiling effect of performance observed in 80% of patients from 20 sessions.
Fatigue could be one candidate to explain the ceiling effect of physical performance during PR. From a theoritical point of view, national and international guidelines on PR have continuously broadened PR interventions for the last 20 years, by progressively introducing in addition to endurance training, resistance training of the lower and then the upper limbs, electrical stimulation, stretching, respiratory muscle training... From a practical point of view, several patients complain of fatigue during PR. 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. Mutdimensional questionnaires and complementary indicators such as heart rate variability or visuomotor reaction time could be introduced.
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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient pulmonary rehabilitation | Multidisciplinary inpatient pulmonary rehabilitation program lasting 4 weeks (40 sessions, 2 sessions per day, 5 days per week). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional fatigue score
Change in total fatigue score measured with the MFI-20 questionnaire
Measured: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Secondary outcomes (4)
6-min walking distance
Change in walking distance during a 6-min period over a corridor of 30m length
Measured: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Heart rate variability
Change in SDNN and RMSSD indices of RR intervals during a 5-min resting period and at exercise during a 6-min walking test
Measured: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Visuomotor reaction time
Change in the mean of 15 reaction time in response to visual stimuli
Measured: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Correlation between fatigue and physical performance
Change in the strength of the correlation between indicators of fatigue (muldimensional score, heart rate variability, visuomotor reaction time) and 6-min walking distance
Measured: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start15 Feb 2020
- Primary completion13 Mar 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- 5 Santé
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Nelly Heraud, PhD, Study director, Direction de la recherche et de l'innovation Santé, GCS CIPS, Korian, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279730
- Sponsor's protocol ID
- 5S_PROMOD
- Acronym
- PROMOD
- Status last verified
- Nov 2023
- First submitted
- 12 Feb 2020
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alexandre F, Molinier V, Hognon L, Charbonnel L, Calvat A, Castanyer A, Henry T, Marcenac A, Jollive M, Vernet A, Oliver N, Heraud N. Time-Course of Changes in Multidimensional Fatigue and Functional Exercise Capacity and Their Associations during a Short Inpatient Pulmonary Rehabilitation Program. COPD. 2023 Dec;20(1):55-63. doi: 10.1080/15412555.2022.2164261.
PubMed 36655947
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fatigue on Physical Performance During a Pulmonary Rehabilitation Program in Patients With COPD
- ClinicalTrials.gov ID
- NCT04279730
- Acronym / sponsor ID
- PROMOD / 5S_PROMOD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- 5 SantéUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 13 Mar 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Exercise tolerance is an important predictor of health status in patients with chronic obstructive pulmonary disease (COPD). A reduced 6-min walking distance is associated with an increased mortality risk in these patients. Pulmonary rehabilitation (PR) is one of the most efficient strategy to counterac this effect. Patients improving their exercise tolerance after a PR program have a reduced mortality risk. However, exercise tolerance improvement is not systematic after PR, since up to 1/3 of patients do not respond to the intervention. In addition, PR's effects are limited, with a ceiling effect of performance observed in 80% of patients from 20 sessions.
Fatigue could be one candidate to explain the ceiling effect of physical performance during PR. From a theoritical point of view, national and international guidelines on PR have continuously broadened PR interventions for the last 20 years, by progressively introducing in addition to endurance training, resistance training of the lower and then the upper limbs, electrical stimulation, stretching, respiratory muscle training... From a practical point of view, several patients complain of fatigue during PR. 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. Mutdimensional questionnaires and complementary indicators such as heart rate variability or visuomotor reaction time could be introduced.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatient pulmonary rehabilitation | – | –Multidisciplinary inpatient pulmonary rehabilitation program lasting 4 weeks (40 sessions, 2 sessions per day, 5 days per week). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admited for an inpatient PR program at one of the three following pulmonary rehabilitation center will be consecutively recruiting: * Clinique du Souffle La Vallonie (Lodève, France) * Clinique du Souffle La Solane (Osseja, France) * Clinique du Souffle Les Clarines (Riom-es-Montagnes, France)
Key inclusion criteria (2 listed)
- Patients admited for a 4-weeks inpatient pulmonary rehabilitation program
- With a confirmed diagnosis of COPD
Key exclusion criteria (3 listed)
- Severe or unstable heart disease
- Orthopedic, neurologic or psychatric comorbities
- Recent exacerbation (<4 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multidimensional fatigue score
Time frame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Change in total fatigue score measured with the MFI-20 questionnaire
4 secondary outcomes
6-min walking distance
Time frame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Heart rate variability
Time frame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Visuomotor reaction time
Time frame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Correlation between fatigue and physical performance
Time frame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Results publication: PubMed 36655947Alexandre F, Molinier V, Hognon L, Charbonnel L, Calvat A, Castanyer A, Henry T, Marcenac A, Jollive M, Vernet A, Oliver N, Heraud N. Time-Course of Changes in Multidimensional Fatigue and Functional Exercise Capacity and Their Associations during a Short Inpatient Pulmonary Rehabilitation Program. COPD. 2023 Dec;20(1):55-63. doi: 10.1080/15412555.2022.2164261.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelly Heraud, PhD study director
Direction de la recherche et de l'innovation Santé, GCS CIPS, Korian, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by 5 Santé at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional fatigue score (time frame: Baseline (T0), 1st week (T1), 2nd week (T2), 3rd week (T3) and 4th week (T4) of the PR program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.