Clinical trial NCT04395937: Effects of Regular Submaximal Exercise on Asthma Control and Quality of Life in Patients With Persistent Symptoms
Official title: Effects of Submaximal Regular Physical Exercise on Quality of Life, Symptomatic Control, and Bronchial and Systemic Inflammatory Markers in Patients With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Asthma
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The effects of regular exercise on asthma control has not yet been well demonstrated.

The aim of this study is to investigate the impact of submaximal physical exercise on quality of life, on symptomatic control, and on bronchial and systemic inflammatory markers in patients with persistant asthma.

Detailed description: While it is well known that intense physical exercise can generate bronchospasm and limit exercise performance, it recently appeared that regular physical exercise practiced aerobically could improve the clinical status of asthmatic patients.

The investigators are planning a 12-week randomized controlled study to assess the effect of regular aerobic exercise on quality of life, asthma control, bronchial hyperresponsiveness and bronchial and systemic inflammation in patients with persistent asthma

The hypothesis is that regular physical exercise increases control and quality of life and reduces inflammation and bronchial hyperresponsiveness compared to simple physiotherapy sessions.

Eligibility criteria: Inclusion Criteria:

* asthmatic patient
* aged 18- 90 years
* ACQ \> 1.5
* stable background treatment comprising at least one inhaled corticosteroid or an anti-leukotriene

Exclusion Criteria:

* IMC \> 35
* severe osteoarthritis of the knees and hips
* unstable angor
* Severe uncontrolled hypertension

Primary outcomes:
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: 3 months
measure: Asthma Control Questionnaire (ACQ)
timeFrame: 3 months
measure: FEV1 (Forced Expiratory volume in 1 second)
timeFrame: 3 months
measure: fall in FEV1 during ergospirometric measurement
timeFrame: 3 months
measure: Amount of eosinophils and neutrophils in sputum
timeFrame: 3 months
measure: FeNo (fractional exhaled nitric oxide)
timeFrame: 3 months
measure: PC20M (measures the concentration of metacholine necessary to bring down the FEV1 by 20% compared to its base value)
timeFrame: 3 months
measure: Vo2max (maximum oxygen consumption)
timeFrame: 3 months
measure: PMA (Maximum aerobic power)
timeFrame: 3 months
measure: sputum cell counts
timeFrame: 3 months
measure: Hospital Anxiety and depression scale (HAD)
timeFrame: 3 months
measure: Asthma control test (ACT)
timeFrame: 3 months
measure: FVC (Forced Vital Capacity)
timeFrame: 3 months
measure: TLC (Total Lung Capacity)
timeFrame: 3 months
measure: DLCO (Diffusing Capacity of the Lung for Carbon Monoxide)
timeFrame: 3 months
measure: KCO (transfer coefficient of the lung for carbon monoxide)
timeFrame: 3 months
measure: FRC (Functional Residual Capacity)
timeFrame: 3 months
measure: RV (Residual Volume)
timeFrame: 3 months
measure: sGaw (Specific airway conductance)
timeFrame: 3 months
measure: maximal inspiratory power
timeFrame: 3 months
measure: maximal expiratory power
timeFrame: 3 months
measure: isometric force of long finger grasp
timeFrame: 3 months
measure: maximum isometric force of the quadriceps
timeFrame: 3 months
measure: VOCs
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Chu Liege
state: Liege
Study officials:
References: