Breathing Control Exercises in Patients With Chronic Obstructive Pulmonary Disease.
Primary Purpose
Severe Chronic Obstructive Pulmonary Disease
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Standard Occupational Therapy
Occupational Therapy with Breathing Control Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Severe Chronic Obstructive Pulmonary Disease focused on measuring COPD, Chronic Obstructive Pulmonary Disease, Occupational therapy, Breathing control
Eligibility Criteria
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
Sites / Locations
- J Bracops HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Occupational Therapy
Occupational Therapy with Breathing Control Exercises
Arm Description
This group will receive standard occupational therapy sessions
This group will receive the same component of the control group + breathing control exercises
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change in dyspnea
Dyspnea is rated with a visual analogic scale (0 to 100mm).
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.
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
Full Information
NCT ID
NCT05199987
First Posted
January 5, 2022
Last Updated
April 6, 2022
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT05199987
Brief Title
Breathing Control Exercises in Patients With Chronic Obstructive Pulmonary Disease.
Official Title
Impact of Occupational Therapy With Breathing Control Exercises in Patients With Chronic Obstructive Pulmonary Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Anticipated)
Study Completion Date
June 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Chronic Obstructive Pulmonary Disease
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Occupational therapy, Breathing control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Occupational Therapy
Arm Type
Active Comparator
Arm Description
This group will receive standard occupational therapy sessions
Arm Title
Occupational Therapy with Breathing Control Exercises
Arm Type
Experimental
Arm Description
This group will receive the same component of the control group + breathing control exercises
Intervention Type
Behavioral
Intervention Name(s)
Standard Occupational Therapy
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Occupational Therapy with Breathing Control Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in St George's Respiratory Questionnaire score
Description
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.
Time Frame
At baseline and after 6 weeks of pulmonary rehabilitation
Secondary Outcome Measure Information:
Title
Change in health-related quality of life
Description
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.
Time Frame
At baseline and after 6 weeks of pulmonary rehabilitation
Title
Change in dyspnea
Description
Dyspnea is rated with a visual analogic scale (0 to 100mm).
Time Frame
At rest and after the effort, at baseline as well as after 6 weeks of pulmonary rehabilitation
Title
Change in hand grip strength
Description
Hand grip strength test is assessed via a hand dynamometer (JAMAR). The best value of three repetitions of the best hand is reported.
Time Frame
At baseline and after 6 weeks of pulmonary rehabilitation
Title
Change in functional capacity
Description
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
Time Frame
At baseline and after 6 weeks of pulmonary rehabilitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
J Bracops Hospital
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurore de Brouchoven de Bergeyck
Phone
003225561212
12. IPD Sharing Statement
Learn more about this trial
Breathing Control Exercises in Patients With Chronic Obstructive Pulmonary Disease.
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