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Breathing Versus Aerobic Exercises on Asthma Control

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Breathing exercise
Aerobic exercise
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Clinical control, Exercise

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Asthma moderate and severe
  • Asthma will diagnosed (Global Initiative for Asthma -GINA)
  • Body Mass Index <35 kg/ m2
  • Sedentary
  • Medical treatment, for at least 6 months
  • Clinically stable

Exclusion Criteria:

  • Smokers
  • Cardiac disease
  • Chronic Obstructive Pulmonary Disease
  • Active Cancer
  • Pregnant

Sites / Locations

  • Hospital das Clínicas da FMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Breathing Exercise

Aerobic Exercise

Arm Description

It will be based on Yoga´s breathing technique (Eliade, 1996) and will be focus on to stimulate nasal and diaphragmatic breathings, to increase expiratory time, to slow respiratory flow and to regulate the breathing rhythm. Breathing exercises will be divided into 3 phases (lasting one month each) with progressive intensity every 8 sessions and will be part of the routine of breathing exercises the following exercises: I) Kapalabhati ; II) Uddhiyana ;III) Surya Bedhana

Exercise will be performed on a treadmill, with the initial intensity of 60% of the maximum predicted heart rate for patient´s age (Tanaka et al, 2001) reaching a maximal of 80% during the training. The intensity values will be calculated using Karvonen's formule (1957).Aerobic training sessions that will consist in 40 minutes divided in 5 minutes of warm-up, 35 minutes of aerobic training and 5 minutes of cool down. Exercise intensity will be increased if the patient do not present any increase in asthma symptoms during the exercise for 2 consecutive training days. The program will be performed twice a week, for 3 months.

Outcomes

Primary Outcome Measures

Change from Clinical Control
Clinical control will be evaluated by Asthma Control Questionnaire (ACQ)

Secondary Outcome Measures

Change from psychosocial morbidity
The psychosocial morbidity will be quantified by health factors related to quality of life (Asthma quality of life questionnaire- AQLQ) and depression and anxiety levels (HAD score)
Change from Daily life physical activity (DLPA)
Daily life physical activity will be assessed using an accelerometer (power Walker SW 610, Japan) that records the total daily number of steps and those performed at moderate intensity ( >110 steps per minute)

Full Information

First Posted
February 3, 2014
Last Updated
February 14, 2014
Sponsor
University of Sao Paulo General Hospital
Collaborators
University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02065258
Brief Title
Breathing Versus Aerobic Exercises on Asthma Control
Official Title
Comparison Between Breathing and Aerobic Exercises on Clinical Control, Psychosocial Morbidity, Thoracoabdominal Kinematics, and Airway Inflammation in Patients With Moderate-to-severe Asthma: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Asthma is a chronic inflammatory airway disease characterized by reversible obstruction, inflammation and hyperresponsiveness to different stimulus. Aerobic and breathing exercises have been demonstrated to benefit asthmatic patients; however, there is no evidence comparing the effectiveness of the treatments. Objective: To compare the effects of aerobic and breathing exercises on clinical control (primary outcome), psychosocial morbidity and daily life physical activity (secondary outcome) in patients with moderate-to-severe persistent asthma. In addition, thoracoabdominal kinematics, heart rate variability and airway and systemic inflammation will be evaluated. The initial hypothesis will be that both exercises present improved clinical control of asthma. Methods: Forty-eight asthmatic adults will be randomly divided into 2 groups: aerobic (AG) and breathing exercises (BG). All treatments will be performed twice a week for 3 months, totalizing 24 sessions of 40 minutes each. Both groups will complete an educational program consisting of 2 classes at the beginning of the interventions. Before and after interventions, the following parameters will be quantified: clinical control, health related quality of life, levels of anxiety and depression, maximal exercise capacity, autonomic nervous imbalance, daily living physical activity, thoracoabdominal kinematics, inflammatory cells in the sputum, fraction of exhaled nitric oxide (FENO) and systemic inflammatory cytokines. Asthma symptoms will be quantified monthly using diaries. Kolmogorov-Smirnov test will be used to analyze the data normality, and a two-way ANOVA with repeated measures with appropriate post hoc test (Student Newman Keuls) will be used to compare the inter and intra-groups differences
Detailed Description
Both groups completed an educational program that consisted of two classes held once a week, each lasting 2 hours. Presentations and group discussions were done, including information about asthma pathophysiology, medication skills, self-monitoring techniques, and environmental control and avoidance strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Clinical control, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breathing Exercise
Arm Type
Active Comparator
Arm Description
It will be based on Yoga´s breathing technique (Eliade, 1996) and will be focus on to stimulate nasal and diaphragmatic breathings, to increase expiratory time, to slow respiratory flow and to regulate the breathing rhythm. Breathing exercises will be divided into 3 phases (lasting one month each) with progressive intensity every 8 sessions and will be part of the routine of breathing exercises the following exercises: I) Kapalabhati ; II) Uddhiyana ;III) Surya Bedhana
Arm Title
Aerobic Exercise
Arm Type
Active Comparator
Arm Description
Exercise will be performed on a treadmill, with the initial intensity of 60% of the maximum predicted heart rate for patient´s age (Tanaka et al, 2001) reaching a maximal of 80% during the training. The intensity values will be calculated using Karvonen's formule (1957).Aerobic training sessions that will consist in 40 minutes divided in 5 minutes of warm-up, 35 minutes of aerobic training and 5 minutes of cool down. Exercise intensity will be increased if the patient do not present any increase in asthma symptoms during the exercise for 2 consecutive training days. The program will be performed twice a week, for 3 months.
Intervention Type
Other
Intervention Name(s)
Breathing exercise
Other Intervention Name(s)
Yoga
Intervention Description
It will be based on Yoga´s breathing technique (Eliade, 1996) and will be focus on to stimulate nasal and diaphragmatic breathings, to increase expiratory time, to slow respiratory flow and to regulate the breathing rhythm. Breathing exercises will be divided into 3 phases (lasting one month each) with progressive intensity every 8 sessions. All participants will be required to maintain their normal medical regimens during the interventions. Will be part of the routine of breathing exercises the following exercises: I) Kapalabhati, II) Uddhiyana
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Other Intervention Name(s)
Aerobic training
Intervention Description
Exercise will be performed on a treadmill (Imbramed Export Plus, Brazil) with the initial intensity of 60% of the maximum predicted heart rate for patient´s age (Tanaka et al, 2001) reaching a maximal of 80% during the training. The intensity values will be calculated using Karvonen's formule (1957). Exercise intensity will be increased if the patient do not present any increase in asthma symptoms during the exercise for 2 consecutive training days. Before and after every session, patients will perform a peak expiratory flow test and if values were lower than 70% of the patient´s maximum value, they will be advised to use the rescue dose of bronchodilator prescribed the their physician
Primary Outcome Measure Information:
Title
Change from Clinical Control
Description
Clinical control will be evaluated by Asthma Control Questionnaire (ACQ)
Time Frame
After 3 months of intervetion
Secondary Outcome Measure Information:
Title
Change from psychosocial morbidity
Description
The psychosocial morbidity will be quantified by health factors related to quality of life (Asthma quality of life questionnaire- AQLQ) and depression and anxiety levels (HAD score)
Time Frame
After 3 months of intervetion
Title
Change from Daily life physical activity (DLPA)
Description
Daily life physical activity will be assessed using an accelerometer (power Walker SW 610, Japan) that records the total daily number of steps and those performed at moderate intensity ( >110 steps per minute)
Time Frame
After 3 months of intervetion
Other Pre-specified Outcome Measures:
Title
Change from Thoracoabdominal kinematics
Description
Thoracoabdominal kinematics will be evaluated by using optoelectronic plethysmography (OEP system, BTS, Italy) as previously described Aliverti et al, 2006.
Time Frame
After 3 months of intervention
Title
Change from Heart rate variability
Description
Heart rate variability will be assessed using heart rate variability (HRV) by a hert rate monitor ( Polar S810i, Finland) previously validated (Gamelin, Berthoin & Bosquet, 2006).
Time Frame
After 3 months of interventions
Title
Change from Airway and systemic inflammation
Description
Airway inflammation will be quantified using the induced sputum , exhaled fraction of nitric oxide . Systemic inflammation will be evaluated by level of plasmatic inflammatory mediators Th1 ( IL-6, TNF) , Th2 (IL-4, IL-5 and IL-13) and anti-inflammatory ( IL-10 and IL-1ra)
Time Frame
After 3 months of interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Asthma moderate and severe Asthma will diagnosed (Global Initiative for Asthma -GINA) Body Mass Index <35 kg/ m2 Sedentary Medical treatment, for at least 6 months Clinically stable Exclusion Criteria: Smokers Cardiac disease Chronic Obstructive Pulmonary Disease Active Cancer Pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celso Carvalho, PhD
Phone
+55 11 30697451
Email
cscarval@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celso RF Carvalho, PT, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas da FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05360-160
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celso RF Carvalho, PhD
First Name & Middle Initial & Last Name & Degree
Milene G Saccomani, Msc
First Name & Middle Initial & Last Name & Degree
Karen B Evaristo
First Name & Middle Initial & Last Name & Degree
Milton A Martins, MD
First Name & Middle Initial & Last Name & Degree
Rafael Stelmach, MD
First Name & Middle Initial & Last Name & Degree
Alberto Cukier, MD
First Name & Middle Initial & Last Name & Degree
Regina M Carvalho-Pinto, MD
First Name & Middle Initial & Last Name & Degree
Marcos Rojo, Dr
First Name & Middle Initial & Last Name & Degree
Danilo F Santaella, Dr
First Name & Middle Initial & Last Name & Degree
Beatriz M Saraiva-Romanholo, PhD
First Name & Middle Initial & Last Name & Degree
Denise Paisani, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32773365
Citation
Evaristo KB, Mendes FAR, Saccomani MG, Cukier A, Carvalho-Pinto RM, Rodrigues MR, Santaella DF, Saraiva-Romanholo BM, Martins MA, Carvalho CRF. Effects of Aerobic Training Versus Breathing Exercises on Asthma Control: A Randomized Trial. J Allergy Clin Immunol Pract. 2020 Oct;8(9):2989-2996.e4. doi: 10.1016/j.jaip.2020.06.042. Epub 2020 Aug 6.
Results Reference
derived
PubMed Identifier
25326140
Citation
Evaristo KB, Saccomani MG, Martins MA, Cukier A, Stelmach R, Rodrigues MR, Santaella DF, Carvalho CR. Comparison between breathing and aerobic exercise on clinical control in patients with moderate-to-severe asthma: protocol of a randomized trial. BMC Pulm Med. 2014 Oct 17;14:160. doi: 10.1186/1471-2466-14-160.
Results Reference
derived

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Breathing Versus Aerobic Exercises on Asthma Control

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