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

Primary Purpose

Chronic Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
exercises
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Asthma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu LiegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

respiratory physiotherapy

respiratory physiotherapy and physical exercises

control group

Arm Description

exercises to improve the way of breathing

intensity determined by the VO2max measured during ergospirometric measure

Outcomes

Primary Outcome Measures

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
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
FEV1 (Forced Expiratory volume in 1 second)
Change from Baseline FEV1 at 3 months
fall in FEV1 during ergospirometric measurement
Change from Baseline fall in FEV1 during ergospirometric measurement
Amount of eosinophils and neutrophils in sputum
Change from baseline in amount of eosinophils and neutrophils in sputum
FeNo (fractional exhaled nitric oxide)
change from baseline FENO at 3 months
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
Vo2max (maximum oxygen consumption)
change from baseline Vo2Max at 3 months
PMA (Maximum aerobic power)
change from baseline PMA at 3 months
sputum cell counts
change from baseline
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
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
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
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
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
KCO (transfer coefficient of the lung for carbon monoxide)
change from baseline KCO at 3 months
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
RV (Residual Volume)
It is the amount of air remaining in the lungs after a maximal expiration Change from baseline RV at 3 months
sGaw (Specific airway conductance)
Change from baseline sGaw at 3 months
maximal inspiratory power
Measured in KPa Change from baseline
maximal expiratory power
Measured in KPa Change from baseline
isometric force of long finger grasp
measured using a Jamar dynamometer change from baseline
maximum isometric force of the quadriceps
measured using a dynamometer Change from baseline
VOCs
volatils organics compounds change form baseline

Secondary Outcome Measures

Full Information

First Posted
May 4, 2020
Last Updated
May 23, 2022
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT04395937
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Asthma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
respiratory physiotherapy
Arm Type
Active Comparator
Arm Description
exercises to improve the way of breathing
Arm Title
respiratory physiotherapy and physical exercises
Arm Type
Experimental
Arm Description
intensity determined by the VO2max measured during ergospirometric measure
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
exercises
Intervention Description
One hour twice a week to practice respiratory exercises, postural exercises, muscular exercises
Primary Outcome Measure Information:
Title
Asthma Quality of Life Questionnaire (AQLQ)
Description
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
Time Frame
3 months
Title
Asthma Control Questionnaire (ACQ)
Description
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
Time Frame
3 months
Title
FEV1 (Forced Expiratory volume in 1 second)
Description
Change from Baseline FEV1 at 3 months
Time Frame
3 months
Title
fall in FEV1 during ergospirometric measurement
Description
Change from Baseline fall in FEV1 during ergospirometric measurement
Time Frame
3 months
Title
Amount of eosinophils and neutrophils in sputum
Description
Change from baseline in amount of eosinophils and neutrophils in sputum
Time Frame
3 months
Title
FeNo (fractional exhaled nitric oxide)
Description
change from baseline FENO at 3 months
Time Frame
3 months
Title
PC20M (measures the concentration of metacholine necessary to bring down the FEV1 by 20% compared to its base value)
Description
Change from baseline PC20M at 3 months
Time Frame
3 months
Title
Vo2max (maximum oxygen consumption)
Description
change from baseline Vo2Max at 3 months
Time Frame
3 months
Title
PMA (Maximum aerobic power)
Description
change from baseline PMA at 3 months
Time Frame
3 months
Title
sputum cell counts
Description
change from baseline
Time Frame
3 months
Title
Hospital Anxiety and depression scale (HAD)
Description
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
Time Frame
3 months
Title
Asthma control test (ACT)
Description
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
Time Frame
3 months
Title
FVC (Forced Vital Capacity)
Description
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
Time Frame
3 months
Title
TLC (Total Lung Capacity)
Description
It is the total volume of air in the lungs after a maximal inspiration change from baseline TLC at 3 months
Time Frame
3 months
Title
DLCO (Diffusing Capacity of the Lung for Carbon Monoxide)
Description
Measures the efficiency of the gas transfer characteristics of the lungs change from baseline DLCO at 3 months
Time Frame
3 months
Title
KCO (transfer coefficient of the lung for carbon monoxide)
Description
change from baseline KCO at 3 months
Time Frame
3 months
Title
FRC (Functional Residual Capacity)
Description
The volume of air present in the lungs at the end of passive expiration Change from baseline FRC at 3 months
Time Frame
3 months
Title
RV (Residual Volume)
Description
It is the amount of air remaining in the lungs after a maximal expiration Change from baseline RV at 3 months
Time Frame
3 months
Title
sGaw (Specific airway conductance)
Description
Change from baseline sGaw at 3 months
Time Frame
3 months
Title
maximal inspiratory power
Description
Measured in KPa Change from baseline
Time Frame
3 months
Title
maximal expiratory power
Description
Measured in KPa Change from baseline
Time Frame
3 months
Title
isometric force of long finger grasp
Description
measured using a Jamar dynamometer change from baseline
Time Frame
3 months
Title
maximum isometric force of the quadriceps
Description
measured using a dynamometer Change from baseline
Time Frame
3 months
Title
VOCs
Description
volatils organics compounds change form baseline
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Ziant
Phone
+3243668568
Email
sziant@chuliege.be
Facility Information:
Facility Name
Chu Liege
City
Liège
State/Province
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
stephanie ziant
Phone
+3243668568
First Name & Middle Initial & Last Name & Degree
Florence Schleich

12. IPD Sharing Statement

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

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