1STST and Muscle Weakness in CF Patients

Cystic Fibrosis Clinical Trial

Official title:

The 1-minute-sit-to-stand Test is Practical to Assess and Follow the Muscle Weakness in Cystic Fibrosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117764
• Other study ID #: Hardy
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: June 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• orthopaedic conditions interfering with mobility or the assessment of skeletal muscle force,

• a pregnancy,

• a pulmonary graft

• a negative response for the informed consent.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Muscle Weakness
• Paresis

Intervention

Device:
• Microfet Dynamometer
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.

Behavioral:
• 1 minute sit to stand test
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.

Device:
• Accelerometer
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.

Locations

Country	Name	City	State
Belgium	Hardy Sophie	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?	At day 0 and day 14 of IV AB