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1STST and Muscle Weakness in CF Patients

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Microfet Dynamometer
1 minute sit to stand test
Accelerometer
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

6 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hardy Sophie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Acute IV AB for exacerbation at hospital

Acute IV AB for exacerbation at home

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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?

Secondary Outcome Measures

Full Information

First Posted
March 31, 2017
Last Updated
June 25, 2020
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03117764
Brief Title
1STST and Muscle Weakness in CF Patients
Official Title
The 1-minute-sit-to-stand Test is Practical to Assess and Follow the Muscle Weakness in Cystic Fibrosis.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute IV AB for exacerbation at hospital
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Acute IV AB for exacerbation at home
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Microfet Dynamometer
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
1 minute sit to stand test
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Accelerometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from peripheral muscular strength at 14 days.
Description
To evaluate the impact of intravenous antibiotherapy on peripheral muscular strength. Is the impact negative or positive?
Time Frame
At day 0 and day 14 of IV AB

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hardy Sophie, MD
Organizational Affiliation
St Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hardy Sophie
City
Bruxelles
ZIP/Postal Code
1170
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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1STST and Muscle Weakness in CF Patients

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