Breathing & Mild Physical Exercise Therapy for Asthma

NCT01509443 | Completed

• 1 other identifier: RA-2011-015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma; Obesity; Breathing exercise

Outcome Measures

Primary Outcomes (1)

• Change in Post-bronchodilator Forced Expired Volume in one second (FEV1)

  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.

  At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)

Secondary Outcomes (3)

• Improvement in other pulmonary functions as well as quality of life assessment

  At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)

• Change in Fraction of exhaled nitric oxide (FeNO)

  At baseline (pre-exercise) and two diiferent time points (3 and 6 months of post-exercise)

• Change in Immunological Markers

  At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)

Study Arms (2)

Interventional

EXPERIMENTAL

Participants will receive standard asthmatic treatment and breathing/mild physical exercise

Other: Exercise

Control Arm

NO INTERVENTION

The control arm will receive standard medical care for asthma

Interventions

Exercise OTHER

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).

Also known as: Deep breathing and mild physical exercise

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dasman Diabetes Institute: lead

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, 15462, Kuwait

Location

MeSH Terms

Conditions

Asthma; Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rasheed Ahmad, PhD

  Principal Investigator, Dasman Diabetes Institute

  PRINCIPAL INVESTIGATOR

• Fahad Al-Ghimlas, MD

  Co-Principal Investigator, Dasman Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 13, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2019
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)