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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05199987
Other study ID # ErgoControl
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 31, 2022
Est. completion date August 15, 2022

Study information

Verified date April 2024
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 15, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
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.

Locations

Country Name City State
Belgium J Bracops Hospital Anderlecht

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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