Severe Chronic Obstructive Pulmonary DiseaseNCT05199987
Breathing Control Exercises in Patients With Chronic Obstructive Pulmonary Disease.
A study testing Standard Occupational Therapy in people with Severe Chronic Obstructive Pulmonary Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Chronic Obstructive Pulmonary Disease
- What is being tested?
- Standard Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jan 2022to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- Standard Occupational Therapy, Occupational Therapy with Breathing Control Exercises
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Occupational therapy, Breathing control
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Occupational TherapyBehavioural
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 ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Occupational Therapy | Active comparator | This group will receive standard occupational therapy sessions Receives: Behavioral: Standard Occupational Therapy |
| Occupational Therapy with Breathing Control Exercises | Experimental | This group will receive the same component of the control group + breathing control exercises Receives: Behavioral: Occupational Therapy with Breathing Control Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and after 6 weeks of pulmonary rehabilitation
Secondary outcomes (4)
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.
Measured: At baseline and after 6 weeks of pulmonary rehabilitation
Change in dyspnea
Dyspnea is rated with a visual analogic scale (0 to 100mm).
Measured: 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.
Measured: 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
Measured: At baseline and after 6 weeks of pulmonary rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start31 Jan 2022
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Poncin, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199987
- Sponsor's protocol ID
- ErgoControl
- Status last verified
- Apr 2024
- First submitted
- 5 Jan 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Occupational Therapy With Breathing Control Exercises in Patients With Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT05199987
- Acronym / sponsor ID
- ErgoControl
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Occupational therapy, Breathing control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Occupational Therapy | Active comparator | Behavioral: Standard Occupational TherapyThis group will receive standard occupational therapy sessions |
| Occupational Therapy with Breathing Control Exercises | Experimental | Behavioral: Occupational Therapy with Breathing Control ExercisesThis group will receive the same component of the control group + breathing control exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Occupational TherapyStandard 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). | Behavioural | Standard Occupational Therapy |
| Occupational Therapy with Breathing Control ExercisesIncludes 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. | Behavioural | Occupational Therapy with Breathing Control Exercises |
Primary outcome
Change in St George's Respiratory Questionnaire score
Time frame: 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.
4 secondary outcomes
Change in health-related quality of life
Time frame: At baseline and after 6 weeks of pulmonary rehabilitation
Change in dyspnea
Time frame: At rest and after the effort, at baseline as well as after 6 weeks of pulmonary rehabilitation
Change in hand grip strength
Time frame: At baseline and after 6 weeks of pulmonary rehabilitation
Change in functional capacity
Time frame: At baseline and after 6 weeks of pulmonary rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Occupational Therapy in people with Severe Chronic Obstructive Pulmonary Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in St George's Respiratory Questionnaire score (time frame: At baseline and after 6 weeks of pulmonary rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.