Cystic FibrosisNCT03117764
1STST and Muscle Weakness in CF Patients
A study testing Microfet Dynamometer, 1 minute sit to stand test and Accelerometer in people with Cystic Fibrosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The investigators know that peripheral muscle weakness and exercise intolerance are prevalent (56%) in cystic fibrosis (Trooster et al, 2009). Physical inactivity is likely to be an important underlying factor. Those conditions are associated with a poor prognosis (Nixon et al, 1992). Read more about this study
- Who is it for?
- Ages 6 to 99 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Microfet Dynamometer, 1 minute sit to stand test and Accelerometer
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2017to 31 Oct 2019
- Phase
- Interventional
- 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 6 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with cystic fibrosis following the definition of Rosentein et al (1997), who undergo an intravenous antibiotic cure for an acute exacerbation or electively since we notice a decline of respiratory lung function
Who cannot join
- orthopaedic conditions interfering with mobility or the assessment of skeletal muscle force,
- a pregnancy,
- a pulmonary graft
- a negative response for the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The 1-minute-sit-to-stand Test is Practical to Assess and Follow the Muscle Weakness in Cystic Fibrosis.
The investigators know that peripheral muscle weakness and exercise intolerance are prevalent (56%) in cystic fibrosis (Trooster et al, 2009). Physical inactivity is likely to be an important underlying factor. Those conditions are associated with a poor prognosis (Nixon et al, 1992). The effect of intravenous antibiotherapy on peripheral muscle and physical activity remains unclear.
The aim of the study is to evaluate the impact of intravenous antibiotherapy on peripheral muscular strength in patients with cystic fibrosis (adults and children) who receive intravenous antibiotherapy for an acute exacerbation or electively (decline in lung function without exacerbation).
Read the detailed description
Background Peripheral muscle weakness and exercise intolerance are prevalent (56%) in cystic fibrosis (Trooster et al, 2009). Physical inactivity is likely to be an important underlying factor. Those conditions are associated with a poor prognosis (Nixon et al, 1992). The effect of intravenous antibiotherapy on peripheral muscle and physical activity remains unclear. Wieboldt et al showed that quadriceps strength at the hospital admission for an exacerbation was lower than before and one month after hospitalisation while Burtin et al showed that individual changes in quadriceps force were correlated with daily time spent activities of at least moderate intensity (Wieboldt et al, 2012; Burtin et al, 2013). The effect of intravenous antibiotherapy itself is poorly known in cystic fibrosis. Moreover, they did not study the impact on muscular strength of hospitalisation versus home treatment. In contrast, in COPD, it is well known that exacerbations are associated with a decline of muscle mass and strength and that repeated exacerbations lead to a more rapid decrease in fat free mass (Spruit et al, 2003; Jones et al, 2015; Joppa et al, 2016).
Hypothesis We think that exacerbations aggravate factors underlying muscle weakness as physical inactivity, systemic inflammation and anabolic status. Moreover, hospitalisation itself might be a reason of inactivity as patients spent all the day inside their room compared to patients who follow their treatment at home and continue their usual life.
Aim The aim of our study is to evaluate the impact of an intravenous antibiotherapy on peripheral muscular strength in patients with cystic fibrosis.
Methods We would compare patients (adults and children) who receive intravenous antibiotherapy for an acute exacerbation, with patients who receive elective intravenous antibiotherapy (decline in lung function without exacerbation). We will also compare hospitalised patients who receive specific exercise training, with patients who follow their antibiotherapy at home without specific exercise training. We will have a stable patients group as control. To evaluate muscular strength we plan to measure quadriceps force at the beginning of the cure and at the end with a functional test, the 1-minute Sit-to-Stand test and a strength (isometric) test, with the Microfet2dynamometer. Those test are not invasive, easy to realise and have already been used in other studies (Ozalevli, 2005). We will quantify the physical activity level of the patients with an accelerometer that they will carry during 72 hours, during the first week of the treatment.
- Conditions
- Cystic Fibrosis
- Being tested
- Microfet Dynamometer, 1 minute sit to stand test, Accelerometer
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfet DynamometerDevice
To evaluate muscular strength, the investigators will measure quadriceps force at the beginning of the cure and at the end with a functional test, the 1-minute Sit-to-Stand test, and a maximal isometric force test, with the Microfet2dynamometer. Those tests are not invasive and easy to realise.
The investigators will estimate the physical activity of the patients with an accelerometer that they will each carry 72 hours, during the cure.
Patients who undergo their cure at the hospital will follow a specific training program with the physiotherapist.
1 minute sit to stand testBehavioural
To evaluate muscular strength, the investigators will measure quadriceps force at the beginning of the cure and at the end with a functional test, the 1-minute Sit-to-Stand test, and a maximal isometric force test, with the Microfet2dynamometer. Those tests are not invasive and easy to realise.
The investigators will estimate the physical activity of the patients with an accelerometer that they will each carry 72 hours, during the cure.
Patients who undergo their cure at the hospital will follow a specific training program with the physiotherapist.
AccelerometerDevice
To evaluate muscular strength, the investigators will measure quadriceps force at the beginning of the cure and at the end with a functional test, the 1-minute Sit-to-Stand test, and a maximal isometric force test, with the Microfet2dynamometer. Those tests are not invasive and easy to realise.
The investigators will estimate the physical activity of the patients with an accelerometer that they will each carry 72 hours, during the cure.
Patients who undergo their cure at the hospital will follow a specific training program with the physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Acute IV AB for exacerbation at hospital | Active comparator | The study will compare muscular strength of hospitalised patients who receive specific exercise training, with patients who follow their antibiotherapy at home without specific exercise training.
Interventions: microfet dynamometer, 1 minute sit to stand test, accelerometer. Receives: Device: Microfet Dynamometer; Behavioral: 1 minute sit to stand test; Device: Accelerometer |
| Acute IV AB for exacerbation at home | Experimental | The study will compare muscular strength of hospitalised patients who receive specific exercise training, with patients who follow their antibiotherapy at home without specific exercise training.
Interventions: microfet dynamometer, 1 minute sit to stand test, accelerometer. Receives: Device: Microfet Dynamometer; Behavioral: 1 minute sit to stand test; Device: Accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from peripheral muscular strength at 14 days.
To evaluate the impact of intravenous antibiotherapy on peripheral muscular strength. Is the impact negative or positive?
Measured: At day 0 and day 14 of IV AB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Oct 2017
- Primary completion30 Sep 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hardy, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- hardy Sophie, MD, Principal investigator, St Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117764
- Sponsor's protocol ID
- Hardy
- Status last verified
- Jun 2020
- First submitted
- 31 Mar 2017
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 1-minute-sit-to-stand Test is Practical to Assess and Follow the Muscle Weakness in Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT03117764
- Acronym / sponsor ID
- Hardy
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 18 Apr 2017 (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.
The investigators know that peripheral muscle weakness and exercise intolerance are prevalent (56%) in cystic fibrosis (Trooster et al, 2009). Physical inactivity is likely to be an important underlying factor. Those conditions are associated with a poor prognosis (Nixon et al, 1992). The effect of intravenous antibiotherapy on peripheral muscle and physical activity remains unclear.
The aim of the study is to evaluate the impact of intravenous antibiotherapy on peripheral muscular strength in patients with cystic fibrosis (adults and children) who receive intravenous antibiotherapy for an acute exacerbation or electively (decline in lung function without exacerbation).
Detailed description
Background Peripheral muscle weakness and exercise intolerance are prevalent (56%) in cystic fibrosis (Trooster et al, 2009). Physical inactivity is likely to be an important underlying factor. Those conditions are associated with a poor prognosis (Nixon et al, 1992). The effect of intravenous antibiotherapy on peripheral muscle and physical activity remains unclear. Wieboldt et al showed that quadriceps strength at the hospital admission for an exacerbation was lower than before and one month after hospitalisation while Burtin et al showed that individual changes in quadriceps force were correlated with daily time spent activities of at least moderate intensity (Wieboldt et al, 2012; Burtin et al, 2013). The effect of intravenous antibiotherapy itself is poorly known in cystic fibrosis. Moreover, they did not study the impact on muscular strength of hospitalisation versus home treatment. In contrast, in COPD, it is well known that exacerbations are associated with a decline of muscle mass and strength and that repeated exacerbations lead to a more rapid decrease in fat free mass (Spruit et al, 2003; Jones et al, 2015; Joppa et al, 2016).
Hypothesis We think that exacerbations aggravate factors underlying muscle weakness as physical inactivity, systemic inflammation and anabolic status. Moreover, hospitalisation itself might be a reason of inactivity as patients spent all the day inside their room compared to patients who follow their treatment at home and continue their usual life.
Aim The aim of our study is to evaluate the impact of an intravenous antibiotherapy on peripheral muscular strength in patients with cystic fibrosis.
Methods We would compare patients (adults and children) who receive intravenous antibiotherapy for an acute exacerbation, with patients who receive elective intravenous antibiotherapy (decline in lung function without exacerbation). We will also compare hospitalised patients who receive specific exercise training, with patients who follow their antibiotherapy at home without specific exercise training. We will have a stable patients group as control. To evaluate muscular strength we plan to measure quadriceps force at the beginning of the cure and at the end with a functional test, the 1-minute Sit-to-Stand test and a strength (isometric) test, with the Microfet2dynamometer. Those test are not invasive, easy to realise and have already been used in other studies (Ozalevli, 2005). We will quantify the physical activity level of the patients with an accelerometer that they will carry during 72 hours, during the first week of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute IV AB for exacerbation at hospital | Active comparator | Device: Microfet Dynamometer, Behavioral: 1 minute sit to stand test, Device: AccelerometerThe study will compare muscular strength of hospitalised patients who receive specific exercise training, with patients who follow their antibiotherapy at home without specific exercise training. Interventions: microfet dynamometer, 1 minute sit to stand test, accelerometer. |
| Acute IV AB for exacerbation at home | Experimental | Device: Microfet Dynamometer, Behavioral: 1 minute sit to stand test, Device: AccelerometerThe study will compare muscular strength of hospitalised patients who receive specific exercise training, with patients who follow their antibiotherapy at home without specific exercise training. Interventions: microfet dynamometer, 1 minute sit to stand test, accelerometer. |
Who may qualify
- Ages
- 6 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with cystic fibrosis following the definition of Rosentein et al (1997), who undergo an intravenous antibiotic cure for an acute exacerbation or electively since we notice a decline of respiratory lung function
Key exclusion criteria (4 listed)
- orthopaedic conditions interfering with mobility or the assessment of skeletal muscle force,
- a pregnancy,
- a pulmonary graft
- a negative response for the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microfet DynamometerTo evaluate muscular strength, the investigators will measure quadriceps force at the beginning of the cure and at the end with a functional test, the 1-minute Sit-to-Stand test, and a maximal isometric force test, with the Microfet2dynamometer. Those tests are not invasive and easy to realise. The investigators will estimate the physical activity of the patients with an accelerometer that they will each carry 72 hours, during the cure. Patients who undergo their cure at the hospital will follow a specific training program with the physiotherapist. | Device | Acute IV AB for exacerbation at home, Acute IV AB for exacerbation at hospital |
| 1 minute sit to stand testTo evaluate muscular strength, the investigators will measure quadriceps force at the beginning of the cure and at the end with a functional test, the 1-minute Sit-to-Stand test, and a maximal isometric force test, with the Microfet2dynamometer. Those tests are not invasive and easy to realise. The investigators will estimate the physical activity of the patients with an accelerometer that they will each carry 72 hours, during the cure. Patients who undergo their cure at the hospital will follow a specific training program with the physiotherapist. | Behavioural | Acute IV AB for exacerbation at home, Acute IV AB for exacerbation at hospital |
| AccelerometerTo evaluate muscular strength, the investigators will measure quadriceps force at the beginning of the cure and at the end with a functional test, the 1-minute Sit-to-Stand test, and a maximal isometric force test, with the Microfet2dynamometer. Those tests are not invasive and easy to realise. The investigators will estimate the physical activity of the patients with an accelerometer that they will each carry 72 hours, during the cure. Patients who undergo their cure at the hospital will follow a specific training program with the physiotherapist. | Device | Acute IV AB for exacerbation at home, Acute IV AB for exacerbation at hospital |
Primary outcome
Change from peripheral muscular strength at 14 days.
Time frame: At day 0 and day 14 of IV AB
To evaluate the impact of intravenous antibiotherapy on peripheral muscular strength. Is the impact negative or positive?
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 29 Jun 2020.
- Individual participant dataSharing planned: No
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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.
hardy Sophie, MD principal investigator
St Luc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfet Dynamometer, 1 minute sit to stand test and Accelerometer in people with Cystic Fibrosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 4 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 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Change from peripheral muscular strength at 14 days. (time frame: At day 0 and day 14 of IV AB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2020.