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

Sponsor
Centre Hospitalier Régional d'Orléans (Other)
Overall Status
Recruiting
CT.gov ID
NCT04668638
Collaborator
(none)
40
1
2
21.7
1.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Respiratory rehabilitation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Patients will be divided into two groups: Group 1 (Control Group) will not immediately receive respiratory rehabilitation but between the 2nd and 4th months postdiagnosis. Group 2 (Intervention Group) will immediately receive rehabilitation between the diagnosis and the 2nd month postdiagnosis.Patients will be divided into two groups:Group 1 (Control Group) will not immediately receive respiratory rehabilitation but between the 2nd and 4th months postdiagnosis. Group 2 (Intervention Group) will immediately receive rehabilitation between the diagnosis and the 2nd month postdiagnosis.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Impact of Respiratory Rehabilitation on Quality of Life, Measures by the SF-36 Score, in Patients With Hyperventilation Syndrome: Crossover, Prospective and Randomized Study
Actual Study Start Date :
Mar 10, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Control group

Group 1 (Control Group) will not immediately receive respiratory rehabilitation but between the 2nd and 4th months postdiagnosis.

Other: Respiratory rehabilitation
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.

Other: Respiratory rehabilitation
Respiratory rehabilitation includes education, hypoventilation exercises, diaphragmatic breathing exercises, relaxation, retraining, others.

Outcome Measures

Primary Outcome Measures

  1. Incidence of respiratory rehabilitation on Quality of life [Day 0]

    Quality of life will be evaluated with the SF-36 score

  2. Incidence of respiratory rehabilitation on Quality of life [Month 2]

    Quality of life will be evaluated with the SF-36 score

  3. Incidence of respiratory rehabilitation on Quality of life [Month 4]

    Quality of life will be evaluated with the SF-36 score

Secondary Outcome Measures

  1. Change in symptomatology [Day 0]

    Change in symptomatology will be evaluated on the Nijmegen questionnaire

  2. Change in symptomatology [Month 2]

    Change in symptomatology will be evaluated on the Nijmegen questionnaire

  3. Change in symptomatology [Month 4]

    Change in symptomatology will be evaluated on the Nijmegen questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHR d'Orléans Orléans France

Sponsors and Collaborators

  • Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Louis-François BIRNESSER, CHR Orléans

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier:
NCT04668638
Other Study ID Numbers:
  • CHRO-2020-19
First Posted:
Dec 16, 2020
Last Update Posted:
Jan 4, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Régional d'Orléans
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2022