Breathing Control Exercises in Patients With Chronic Obstructive Pulmonary Disease.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)

Overall Status

Recruiting

CT.gov ID

NCT05199987

Collaborator

(none)

Enrollment

Location

Arms

4.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Severe Chronic Obstructive Pulmonary Disease	Behavioral: Standard Occupational Therapy Behavioral: Occupational Therapy with Breathing Control Exercises	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 31, 2022

Anticipated Primary Completion Date :

Jun 15, 2022

Anticipated Study Completion Date :

Jun 15, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in St George's Respiratory Questionnaire score [At baseline and after 6 weeks of pulmonary rehabilitation]
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 [At baseline and after 6 weeks of pulmonary rehabilitation]
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 [At rest and after the effort, at baseline as well as after 6 weeks of pulmonary rehabilitation]
Dyspnea is rated with a visual analogic scale (0 to 100mm).
Change in hand grip strength [At baseline and after 6 weeks of pulmonary rehabilitation]
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 [At baseline and after 6 weeks of pulmonary rehabilitation]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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