1STST and Muscle Weakness in CF Patients

NCT03117764 | Completed

• 1 other identifier: Hardy
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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).

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Device: Microfet Dynamometer; Behavioral: 1 minute sit to stand test; Device: Accelerometer

Interventions

Microfet Dynamometer DEVICE

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.

Acute IV AB for exacerbation at home; Acute IV AB for exacerbation at hospital

1 minute sit to stand test BEHAVIORAL

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.

Acute IV AB for exacerbation at home; Acute IV AB for exacerbation at hospital

Accelerometer DEVICE

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.

Acute IV AB for exacerbation at home; Acute IV AB for exacerbation at hospital

Eligibility Criteria

• Age: 6 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• orthopaedic conditions interfering with mobility or the assessment of skeletal muscle force,
• a pregnancy,
• a pulmonary graft
• a negative response for the informed consent.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Hardy Sophie

Brussels, 1170, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• hardy Sophie, MD

  St Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Pneumology assistant

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 18, 2017
• Study Start: October 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: October 31, 2019
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)