Impact of Respiratory Rehabilitation on Quality of Life in Patients With Hyperventilation Syndrome (RESPIR-HVS)

February 15, 2023 updated by: Centre Hospitalier Régional d'Orléans

Impact of Respiratory Rehabilitation on Quality of Life, Measures by the SF-36 Score, in Patients With Hyperventilation Syndrome: Crossover, Prospective and Randomized Study

The hyperventilation syndrome is a quite frequent pathology, affecting up to 10% of the general population and 40% of the asthmatic population. Its physiopathology is still badly known and even if it is a benign affection, its associated comorbidities and symptomatology greatly decrease the patients' quality of life. Yet, no medicinal treatments have been proved useful, but prescribers noticed improvements after physiotherapy. Given that the physiotherapy impact on hyperventilation syndrome is not well described in the literature, this study aims to scientifically ascertain physiotherapy benefits on quality of life and symptomatology in hyperventilation syndrome-suffering patients.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Orléans, France
        • Recruiting
        • CHR d'Orléans
        • Contact:
        • Principal Investigator:
          • Nicolas LEBRUN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive hyperventilation syndrome diagnosis
  • Having a social security insurance
  • Being at least 18 years old
  • Having given their written consent

Exclusion Criteria:

  • Being put under guardianship or curatorship
  • Having seen a physiotherapist for a respiratory rehabilitation in the last three months
  • Suffering from a chronic and degenerative pathology (chronic obstructive pulmonary disease, Parkinson's disease, idiopathic fibrosis, …)
  • Not being able to receive the respiratory rehabilitation from our care providers
  • Already having received a rehabilitation for hyperventilation syndrome
  • Not speaking French or not being unable to complete the questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Group 1 (Control Group) will not immediately receive respiratory rehabilitation but between the 2nd and 4th months postdiagnosis.
Respiratory rehabilitation includes education, hypoventilation exercises, diaphragmatic breathing exercises, relaxation, retraining, others.
Other: Intervention group
Group 2 (Intervention Group) will immediately receive rehabilitation between the diagnosis and the 2nd month postdiagnosis.
Respiratory rehabilitation includes education, hypoventilation exercises, diaphragmatic breathing exercises, relaxation, retraining, others.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of respiratory rehabilitation on Quality of life
Time Frame: Day 0
Quality of life will be evaluated with the SF-36 score
Day 0
Incidence of respiratory rehabilitation on Quality of life
Time Frame: Month 2
Quality of life will be evaluated with the SF-36 score
Month 2
Incidence of respiratory rehabilitation on Quality of life
Time Frame: Month 4
Quality of life will be evaluated with the SF-36 score
Month 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in symptomatology
Time Frame: Day 0
Change in symptomatology will be evaluated on the Nijmegen questionnaire
Day 0
Change in symptomatology
Time Frame: Month 2
Change in symptomatology will be evaluated on the Nijmegen questionnaire
Month 2
Change in symptomatology
Time Frame: Month 4
Change in symptomatology will be evaluated on the Nijmegen questionnaire
Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Louis-François BIRNESSER, CHR Orleans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

December 9, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperventilation Syndrome

Clinical Trials on Respiratory rehabilitation

3
Subscribe