NCT05199987

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

January 5, 2022

Last Update Submit

April 13, 2024

Conditions

Keywords

COPDChronic Obstructive Pulmonary DiseaseOccupational therapyBreathing control

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in health-related quality of life

    At baseline and after 6 weeks of pulmonary rehabilitation

  • Change in dyspnea

    At rest and after the effort, at baseline as well as after 6 weeks of pulmonary rehabilitation

  • Change in hand grip strength

    At baseline and after 6 weeks of pulmonary rehabilitation

  • Change in functional capacity

    At baseline and after 6 weeks of pulmonary rehabilitation

Study Arms (2)

Standard Occupational Therapy

ACTIVE COMPARATOR

This group will receive standard occupational therapy sessions

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

Behavioral: Occupational Therapy with Breathing Control Exercises

Interventions

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).

Standard Occupational Therapy

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.

Occupational Therapy with Breathing Control Exercises

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

J Bracops Hospital

Anderlecht, 1070, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 20, 2022

Study Start

January 31, 2022

Primary Completion

August 15, 2022

Study Completion

August 15, 2022

Last Updated

April 16, 2024

Record last verified: 2024-04

Locations