Effects of Regular Submaximal Exercise on Asthma Control and Quality of Life in Patients With Persistent Symptoms

Chronic Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04395937
• Other study ID #: B707202042981
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2021
• Source: University of Liege
• Contact: Stephanie Ziant
• Phone: +3243668568
• Email: sziant[@]chuliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Asthma

Intervention

Other:
• exercises
One hour twice a week to practice respiratory exercises, postural exercises, muscular exercises

Locations

Country	Name	City	State
Belgium	Chu Liege	Liège	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Quality of Life Questionnaire (AQLQ)	A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease 32 items with 2-week recall, 4 different domains : Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items) 7-point Likert scale (7 = not impaired at all - 1 = severely impaired) Scores range 1-7, with higher scores indicating better quality of life. Change from Baseline AQLQ at 3 months	3 months
Primary	Asthma Control Questionnaire (ACQ)	A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment.; 7 items; 1 week recall (for items on symptoms and rescue inhaler use) ACQ has a multidimensional construct assessing symptoms (5 items--self-administered) and rescue bronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%) Scores range between 0 (totally controlled) and 6 (severely uncontrolled). Change from Baseline ACQ at 3 months	3 months
Primary	FEV1 (Forced Expiratory volume in 1 second)	Change from Baseline FEV1 at 3 months	3 months
Primary	fall in FEV1 during ergospirometric measurement	Change from Baseline fall in FEV1 during ergospirometric measurement	3 months
Primary	Amount of eosinophils and neutrophils in sputum	Change from baseline in amount of eosinophils and neutrophils in sputum	3 months
Primary	FeNo (fractional exhaled nitric oxide)	change from baseline FENO at 3 months	3 months
Primary	PC20M (measures the concentration of metacholine necessary to bring down the FEV1 by 20% compared to its base value)	Change from baseline PC20M at 3 months	3 months
Primary	Vo2max (maximum oxygen consumption)	change from baseline Vo2Max at 3 months	3 months
Primary	PMA (Maximum aerobic power)	change from baseline PMA at 3 months	3 months
Primary	sputum cell counts	change from baseline	3 months
Primary	Hospital Anxiety and depression scale (HAD)	The questionnaire comprises seven questions for anxiety and seven questions for depression For each item, 4 response modes coded from 0 to 3. The anxiety and depression items are alternating. In addition, an alteration in the order of the ratings was carried out to avoid biases linked to their repetition.; An overall score is calculated by adding the 14 items but also 2 subtotals corresponding to the 2 subscales. The higher the scores, the higher the symptomatology.; From 0 to 7 : absence of anxiety disorders and depressive disorders From 8 to 10 : anxiety and depressive disorders suspected From 11 to 21 : severe anxiety and depressive disorders	3 months
Primary	Asthma control test (ACT)	change from baseline A questionnaire to determine if patient's asthma symptoms are well controlled. A score varying between 1 and 5 is assigned to each question. A score varying between 1 and 5 is assigned to each question. The higher the total score, the better the asthma is controlled From 1 to 14 : Uncontrolled asthma From 15 to 19 : Partially Controlled Asthma From 20 to 25 : Well controlled asthma	3 months
Primary	FVC (Forced Vital Capacity)	FVC is the greatest total amount of air the patient can forcefully breathe out after breathing in as deeply as possible Change from Baseline FVC1 at 3 months	3 months
Primary	TLC (Total Lung Capacity)	It is the total volume of air in the lungs after a maximal inspiration change from baseline TLC at 3 months	3 months
Primary	DLCO (Diffusing Capacity of the Lung for Carbon Monoxide)	Measures the efficiency of the gas transfer characteristics of the lungs change from baseline DLCO at 3 months	3 months
Primary	KCO (transfer coefficient of the lung for carbon monoxide)	change from baseline KCO at 3 months	3 months
Primary	FRC (Functional Residual Capacity)	The volume of air present in the lungs at the end of passive expiration Change from baseline FRC at 3 months	3 months
Primary	RV (Residual Volume)	It is the amount of air remaining in the lungs after a maximal expiration Change from baseline RV at 3 months	3 months
Primary	sGaw (Specific airway conductance)	Change from baseline sGaw at 3 months	3 months
Primary	maximal inspiratory power	Measured in KPa Change from baseline	3 months
Primary	maximal expiratory power	Measured in KPa Change from baseline	3 months
Primary	isometric force of long finger grasp	measured using a Jamar dynamometer change from baseline	3 months
Primary	maximum isometric force of the quadriceps	measured using a dynamometer Change from baseline	3 months
Primary	VOCs	volatils organics compounds change form baseline	3 months