Breathing & Mild Physical Exercise Therapy for Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Dasman Diabetes Institute
Sponsor:
Information provided by (Responsible Party):
Rasheed Ahmad, PhD, Dasman Diabetes Institute
ClinicalTrials.gov Identifier:
NCT01509443
First received: January 2, 2012
Last updated: May 19, 2013
Last verified: December 2011
  Purpose

Overall goal: To apply the investigators' well defined simple, few-minute breathing/ mild physical exercise program and evaluate its efficacy/benefits for the improvement of clinico-immunological outcome in obese patients with asthma.

Rationale & Hypothesis: Different breathing exercise regimens currently recommended are not well defined and in certain cases may worsen dyspnea or even trigger an asthma attack. Therefore, it is important to evaluate the overall usefulness of a breathing exercise as a therapeutic intervention of asthma. In this regard, the investigators have designed an easy, few-minute breathing exercise program as a treatment modality for asthma and to evaluate its efficacy in improving associated clinico-immunological symptoms. The investigators hypothesize that the investigators' well-designed breathing/mild physical exercise intervention for obese patients will help alleviate the stress and symptoms of asthma by reducing the chronic low-grade systemic inflammation and thus potentiate the beneficial outcome of medication to render a better control over the disease and to improve the quality of life in obese patients.

Clinical relevance/Significance:

The investigators expect that their exercise module will help reduce inflammation caused by asthma, and thereby relieving symptoms of asthma. If successful, this would allow regular individualized exercise module to be recommended as a part of therapy for people with asthma, which could possibly reduce the dosage as well as frequency of taking medicine that they need.


Condition Intervention
Asthma
Other: Exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Application of Breathing Exercise Program to Improve Asthma in Obese Patients: Effects on Clinico-immunological Parameters

Resource links provided by NLM:


Further study details as provided by Dasman Diabetes Institute:

Primary Outcome Measures:
  • Change in Post-bronchodilator Forced Expired Volume in one second (FEV1) [ Time Frame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise) ] [ Designated as safety issue: No ]
    Investigators are expecting positive changes (improvement) in Forced Expired Volume in one second (FEV1) over the course of time. FEV1 is an indicator of improvement in the lung functions and, therefore, asthma control.


Secondary Outcome Measures:
  • Improvement in other pulmonary functions as well as quality of life assessment [ Time Frame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise) ] [ Designated as safety issue: No ]
    Other pulmonary function tests will be measured for the assessment of pulmonary function. A standard Asthma Control Questionnaire will be used to measure improvement in the quality of life

  • Change in Fraction of exhaled nitric oxide (FeNO) [ Time Frame: At baseline (pre-exercise) and two diiferent time points (3 and 6 months of post-exercise) ] [ Designated as safety issue: No ]
  • Change in Immunological Markers [ Time Frame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise) ] [ Designated as safety issue: No ]
    To determine how the protocol specific intervention affects Immunological Markers.


Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional
Participants will receive standard asthmatic treatment and breathing/mild physical exercise
Other: Exercise
Participants will perform 2-4 sessions of the prescribed exercise every day (One session: deep breathing 5-10 times; upper body stretching 5-10 times).
Other Name: Deep breathing and mild physical exercise
No Intervention: Control Arm
The control arm will receive standard medical care for asthma

Detailed Description:

Asthmatics particularly obese have major constraints impeding regular physical activity and exercise. Indeed, the few studies that have resorted to the option of exercise in asthmatic patients also recognized the exacerbation of associated symptoms as a major limitation of this approach. Considering the other obstacles that are often involved, such as lack of time and motivation, inadequate social support and lack of access to facilities etc, it is therefore all the more necessary to design a simple, feasible and carefully tailored breathing exercise modality in obese patients with asthma, and to study its impact on the improvement of clinico-immunological parameters, lung function and overall quality of life. To this end, investigators have developed a safe and feasible light breathing exercise program for individuals with asthma based on our previous observations.

Study Aims & Objectives:

The investigators' main goal is to apply a well defined simple exercise program that includes physical and breathing exercise lessons and evaluate its effects on the improvement of clinico-immunological outcome in obese patients with asthma. There are three main objectives based on clinic-immunological outcome.

  1. To assess the improvement of asthma control, lung function and airways hyper-reactivity after the intervention.
  2. To test if the proposed intervention will result in the improvement of pro-inflammatory profiles.
  3. To determine if physical and psychological performances as well as health related quality of life are positively impacted by the proposed exercise modality.

About 200 individuals with asthma will be enrolled in this study and divided into two groups: The intervention group and controls. The intervention group will receive standard asthma care along with breathing/mild physical exercise. The control group will be the asthmatic patients who are not willing to receive the exercise intervention. At study entry, participants will undergo a clinical assessment which includes physical exam, asthma control/ quality of life questionnaires, pulmonary function tests, and lung inflammation test (Exhaled Nitric Oxide). To monitor participants throughout the study, follow up visits will be done at 6, 12, 18 and 24 weeks after starting the exercise. About 40 ml blood will be collected at baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise). The blood samples will be used for pro-inflammatory profiles. Duration of the study will be three years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals who report a physician-made diagnosis of asthma
  • Non-smokers and ex-smokers (should have stopped smoking at least 1 year ago)

Exclusion Criteria:

  • Contraindications to exercise
  • Inability to exercise
  • Current smokers or those who stopped smoking within the last week
  • Presence of other lung diseases besides asthma
  • Patients on systemic steroids
  • Major co-morbidities inhibiting participants from being involved in an exercise program
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509443

Contacts
Contact: Fahad Al-Ghimlas, MD 965 2224 2999 ext 4909 fahad.alghimlas@dasmaninstitute.org
Contact: Rasheed Ahmad, PhD +965 2224 2999 ext 4311 rasheed.ahmad@dasmaninstitute.org

Locations
Kuwait
Dasman Diabetes Institute Recruiting
Kuwait, Kuwait, 15462
Contact: Fahad Al-Ghimlas, MD    965 2224 2999 ext 4909    fahad.alghimlas@dasmaninstitute.org   
Contact: Rasheed Ahmad, PhD    965 2224 2999 ext 4311    rasheed.ahmad@dasmaninstitute.org   
Sub-Investigator: Amal Hasan, PhD         
Sub-Investigator: Cynthia Lehe, MSc         
Sponsors and Collaborators
Dasman Diabetes Institute
Investigators
Principal Investigator: Rasheed Ahmad, PhD Principal Investigator, Dasman Diabetes Institute
Principal Investigator: Fahad Al-Ghimlas, MD Co-Principal Investigator, Dasman Diabetes Institute
  More Information

No publications provided

Responsible Party: Rasheed Ahmad, PhD, Principal Investigator, Dasman Diabetes Institute
ClinicalTrials.gov Identifier: NCT01509443     History of Changes
Other Study ID Numbers: RA-2011-015
Study First Received: January 2, 2012
Last Updated: May 19, 2013
Health Authority: Kuwait: Office of Research Affairs/ Ethical Review Committee, Dasman Diabetes Institute

Keywords provided by Dasman Diabetes Institute:
Asthma
Obesity
Breathing exercise

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014