Breathing Control Exercises in Patients With Chronic Obstructive Pulmonary Disease.

Impact of Occupational Therapy With Breathing Control Exercises in Patients With Chronic Obstructive Pulmonary Disease.

The purpose of this study is to test whether breathing control exercises embedded in occupational therapy sessions have an impact on quality of life and dyspnea in patients with chronic obstructive pulmonary disease (COPD).

Study Overview

• Status: Completed
• Conditions: Severe Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Standard Occupational Therapy; Behavioral: Occupational Therapy with Breathing Control Exercises

Detailed Description

Dyspnea is one of the most important and debilitating symptoms in patients with COPD and is often the starting point to the vicious cycle of physical inactivity. As a consequence of increased dyspnea, patients adapt themselves by reducing the amount of all activities of daily living performed, with a consequent reduction in quality of life.

Occupational therapists are involved in pulmonary rehabilitation programs aiming to improve the biopsychosocial condition of COPD patients. However, the specific roles and intervention of occupational therapists are not well-defined, and standardized protocols are lacking. The implementation of breathing control exercises in occupational therapy sessions, aiming among other things to regulate patient's breathing during their activities of daily living, could be a starting point for a more effective management of patients with COPD. This could ultimately participate in the improvement of quality of life in patients with COPD.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Anderlecht, Belgium, 1070
    • J Bracops Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Confirmed diagnostic of COPD
• Severity of COPD: global initiative for chronic obstructive lung disease (GOLD) classification III or IV
• Undergoing a pulmonary rehabilitation program in J. Bracops Hospital

Exclusion Criteria:

• Cardiac or orthopedic complications limiting participation in occupational therapy sessions
• Active smoking
• Inability to understand the French language orally or in writing
• Cognitive impairments limiting understanding of instructions and participation in occupational therapy sessions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Occupational Therapy; This group will receive standard occupational therapy sessions	Behavioral: Standard Occupational Therapy; Standard occupational therapy sessions include patient therapeutic education (implementation of strategies and/or technical aids promoting autonomy and independence), walking and stair exercises in real-life conditions (weighted shopping bag, unstable ground, ...), as well as work on activities of daily living aiming to improve toileting skills (includes individual assessment, the use of technical aids depending of this assessment, and personalised strategies to conserve energy).
Experimental: Occupational Therapy with Breathing Control Exercises; This group will receive the same component of the control group + breathing control exercises	Behavioral: Occupational Therapy with Breathing Control Exercises; Includes the same treatment than the one described in standard occupation therapy but with the addition of 30-minute sessions per day on breathing control exercises. These exercises included the reproduction of gestures reproducing daily activities and simultaneous explanations of breathing techniques that the patient can perform in order to set up strategies for saving breath during exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in St George's Respiratory Questionnaire score	Overall health, daily life, and perceived well-being are assessed via the St George's Respiratory Questionnaire and its three domains: "symptoms", "activities" and "impact". The score for each domain and the total score ranged from 0 to 100, with 100 indicating a very poor quality of life.	At baseline and after 6 weeks of pulmonary rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in health-related quality of life	Health-related quality of life is assessed via the CAT (COPD assessment test) score. The assessment consists of eight questions, with a score associated with each question ranging from 0 to 5, with 0 indicating no impact on quality of life. The total score ranges from 0 to 40. The higher the score, the greater the impact on quality of life.	At baseline and after 6 weeks of pulmonary rehabilitation
Change in dyspnea	Dyspnea is rated with a visual analogic scale (0 to 100mm).	At rest and after the effort, at baseline as well as after 6 weeks of pulmonary rehabilitation
Change in hand grip strength	Hand grip strength test is assessed via a hand dynamometer (JAMAR). The best value of three repetitions of the best hand is reported.	At baseline and after 6 weeks of pulmonary rehabilitation
Change in functional capacity	Functional capacity is assessed with the five-time sit-to-stand test. The time the individual takes to sit down and stand up completely over five repetitions is reported	At baseline and after 6 weeks of pulmonary rehabilitation

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): August 15, 2022

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease; Occupational therapy; Breathing control
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ErgoControl

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No