Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis

Terminated

• Conditions: ALS (Amyotrophic Lateral Sclerosis)
• Interventions: Other: Diaphragmatic endurance test

• Registration Number: NCT02528071
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease which involves respiratory muscles and can lead at short term to respiratory failure. The occurrence of respiratory failure is associated with morbidity and an increased mortality. To date, respiratory muscle weakness is predicted from the reduction of vital capacity, maximal inspiratory force, nocturnal symptoms and hypercapnia. Even taken together, the predictive value of these indices is low.

The investigators hypothesize that an endurance test of diaphragmatic work would be more sensitive to respiratory muscle involvement than maximal respiratory force.

Consequently, the investigators assessed diaphragmatic performance through an isocapnic hyperventilation test (IHT) in patients at the onset of ALS and, then regularly up to the occurrence of respiratory failure. The investigators make the hypothesis that IHT will be altered earlier than maximal inspiratory force

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-29
• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Primary Completion: 2020-10-28
• Study Completion: 2020-10-28
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-31
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Diaphragmatic endurance test	ALS patients performing measurements of maximal respiratory forces, diaphragmatic endurance during a diaphragmatic endurance test and phrenic nerve activity at the onset of the disease and repeated every 3 months up to respiratory failure or death
Control	Diaphragmatic endurance test	Healthy controls performing measurements of maximal respiratory forces, diaphragmatic endurance during a diaphragmatic endurance test and phrenic nerve activity. This arm will enable to establish reference values of IHT

Primary Outcome Measures

Name	Time	Method
Endurance time	Day 1	Difference in endurance time during the IHT between healthy controls and ALS patients when diagnosis is established

Secondary Outcome Measures

Name	Time	Method
Reference values of the diaphragmatic endurance test	Day 1	Reference values of the diaphragmatic endurance test in healthy controls according to age, by 10 years range.
Latency of phrenic nerve	At Day 1 and every 3 months of follow-up (3 years)	It is the relationship between phrenic nerve activity and diaphragmatic endurance in ALS patients
Slope of endurance time decrease	At Day 1 and every 3 months of follow-up (3 years)	Slope of endurance time decrease with time in ALS patients measured during IHT
Reference values of phrenic nerve activity	Day 1	Reference values of phrenic nerve activity in healthy controls according to age. It is measured with diaphragmatic Electromyogram by cervical electrical stimulation.
Amplitude of phrenic nerve	At Day 1 and every 3 months of follow-up (3 years)	It is the relationship between phrenic nerve activity and diaphragmatic endurance in ALS patients

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France