search
Back to results

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

Primary Purpose

Hyperventilation Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Respiratory rehabilitation
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperventilation Syndrome focused on measuring Hyperventilation syndrome, Respiratory rehabilitation, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'OrléansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control group

Intervention group

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of respiratory rehabilitation on Quality of life
Quality of life will be evaluated with the SF-36 score
Incidence of respiratory rehabilitation on Quality of life
Quality of life will be evaluated with the SF-36 score
Incidence of respiratory rehabilitation on Quality of life
Quality of life will be evaluated with the SF-36 score

Secondary Outcome Measures

Change in symptomatology
Change in symptomatology will be evaluated on the Nijmegen questionnaire
Change in symptomatology
Change in symptomatology will be evaluated on the Nijmegen questionnaire
Change in symptomatology
Change in symptomatology will be evaluated on the Nijmegen questionnaire

Full Information

First Posted
December 9, 2020
Last Updated
February 15, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
search

1. Study Identification

Unique Protocol Identification Number
NCT04668638
Brief Title
Impact of Respiratory Rehabilitation on Quality of Life in Patients With Hyperventilation Syndrome
Acronym
RESPIR-HVS
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperventilation Syndrome
Keywords
Hyperventilation syndrome, Respiratory rehabilitation, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
Group 1 (Control Group) will not immediately receive respiratory rehabilitation but between the 2nd and 4th months postdiagnosis.
Arm Title
Intervention group
Arm Type
Other
Arm Description
Group 2 (Intervention Group) will immediately receive rehabilitation between the diagnosis and the 2nd month postdiagnosis.
Intervention Type
Other
Intervention Name(s)
Respiratory rehabilitation
Intervention Description
Respiratory rehabilitation includes education, hypoventilation exercises, diaphragmatic breathing exercises, relaxation, retraining, others.
Primary Outcome Measure Information:
Title
Incidence of respiratory rehabilitation on Quality of life
Description
Quality of life will be evaluated with the SF-36 score
Time Frame
Day 0
Title
Incidence of respiratory rehabilitation on Quality of life
Description
Quality of life will be evaluated with the SF-36 score
Time Frame
Month 2
Title
Incidence of respiratory rehabilitation on Quality of life
Description
Quality of life will be evaluated with the SF-36 score
Time Frame
Month 4
Secondary Outcome Measure Information:
Title
Change in symptomatology
Description
Change in symptomatology will be evaluated on the Nijmegen questionnaire
Time Frame
Day 0
Title
Change in symptomatology
Description
Change in symptomatology will be evaluated on the Nijmegen questionnaire
Time Frame
Month 2
Title
Change in symptomatology
Description
Change in symptomatology will be evaluated on the Nijmegen questionnaire
Time Frame
Month 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie DESPUJOLS
Phone
+33238744071
Email
aurelie.despujols@chr-orleans.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie POUGOUE TOUKO
Phone
+33238744086
Email
elodie.pougoue-touko@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis-François BIRNESSER
Organizational Affiliation
CHR Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orléans
City
Orléans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas LEBRUN
Phone
+33238514444
Email
nicolas.lebrun@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Nicolas LEBRUN

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8620731
Citation
Gardner WN. The pathophysiology of hyperventilation disorders. Chest. 1996 Feb;109(2):516-34. doi: 10.1378/chest.109.2.516. No abstract available.
Results Reference
background
PubMed Identifier
3708188
Citation
Lewis RA, Howell JB. Definition of the hyperventilation syndrome. Bull Eur Physiopathol Respir. 1986 Mar-Apr;22(2):201-5.
Results Reference
background
PubMed Identifier
11337441
Citation
Thomas M, McKinley RK, Freeman E, Foy C. Prevalence of dysfunctional breathing in patients treated for asthma in primary care: cross sectional survey. BMJ. 2001 May 5;322(7294):1098-100. doi: 10.1136/bmj.322.7294.1098.
Results Reference
background
PubMed Identifier
20768329
Citation
Lewis T, Cotton, Barcroft J, Dufton D, Milroy TR, Parsons TR. BREATHLESSNESS IN SOLDIERS SUFFERING FROM IRRITABLE HEART. Br Med J. 1916 Oct 14;2(2911):517-9. doi: 10.1136/bmj.2.2911.517. No abstract available.
Results Reference
background
PubMed Identifier
4009520
Citation
van Dixhoorn J, Duivenvoorden HJ. Efficacy of Nijmegen Questionnaire in recognition of the hyperventilation syndrome. J Psychosom Res. 1985;29(2):199-206. doi: 10.1016/0022-3999(85)90042-x.
Results Reference
background
PubMed Identifier
1855568
Citation
Vansteenkiste J, Rochette F, Demedts M. Diagnostic tests of hyperventilation syndrome. Eur Respir J. 1991 Apr;4(4):393-9.
Results Reference
background
PubMed Identifier
7918753
Citation
Nixon PG. Effort syndrome: hyperventilation and reduction of anaerobic threshold. Biofeedback Self Regul. 1994 Jun;19(2):155-69. doi: 10.1007/BF01776488.
Results Reference
background
PubMed Identifier
24269004
Citation
Chenivesse C, Similowski T, Bautin N, Fournier C, Robin S, Wallaert B, Perez T. Severely impaired health-related quality of life in chronic hyperventilation patients: exploratory data. Respir Med. 2014 Mar;108(3):517-23. doi: 10.1016/j.rmed.2013.10.024. Epub 2013 Nov 7.
Results Reference
background
PubMed Identifier
6388711
Citation
Kraft AR, Hoogduin CA. The hyperventilation syndrome. A pilot study on the effectiveness of treatment. Br J Psychiatry. 1984 Nov;145:538-42. doi: 10.1192/bjp.145.5.538.
Results Reference
background
PubMed Identifier
8926595
Citation
Van De Ven LL, Mouthaan BJ, Hoes MJ. Treatment of the hyperventilation syndrome with bisoprolol: a placebo-controlled clinical trial. J Psychosom Res. 1995 Nov;39(8):1007-13. doi: 10.1016/0022-3999(95)00508-0.
Results Reference
background
PubMed Identifier
7367465
Citation
Hoes MJ, Colla P, Folgering H. Clomipramine treatment of hyperventilation syndrome. Pharmakopsychiatr Neuropsychopharmakol. 1980 Jan;13(1):25-8. doi: 10.1055/s-2007-1019606.
Results Reference
background
PubMed Identifier
23728685
Citation
Jones M, Harvey A, Marston L, O'Connell NE. Breathing exercises for dysfunctional breathing/hyperventilation syndrome in adults. Cochrane Database Syst Rev. 2013 May 31;(5):CD009041. doi: 10.1002/14651858.CD009041.pub2.
Results Reference
background

Learn more about this trial

Impact of Respiratory Rehabilitation on Quality of Life in Patients With Hyperventilation Syndrome

We'll reach out to this number within 24 hrs