Clinical trial NCT04668638: Impact of Respiratory Rehabilitation on Quality of Life in Patients With Hyperventilation Syndrome
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
Overall status: RECRUITING
Phase: NA
Conditions: Hyperventilation Syndrome
Keywords: Hyperventilation syndrome
Respiratory rehabilitation
Quality of Life
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Incidence of respiratory rehabilitation on Quality of life
timeFrame: Day 0
measure: Incidence of respiratory rehabilitation on Quality of life
timeFrame: Month 2
measure: Incidence of respiratory rehabilitation on Quality of life
timeFrame: Month 4
Secondary outcomes:
measure: Change in symptomatology
timeFrame: Day 0
measure: Change in symptomatology
timeFrame: Month 2
measure: Change in symptomatology
timeFrame: Month 4
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orléans
Study officials:
affiliation: CHR Orléans
name: Louis-François BIRNESSER
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Lewis RA, Howell JB. Definition of the hyperventilation syndrome. Bull Eur Physiopathol Respir. 1986 Mar-Apr;22(2):201-5.
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.
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.
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.
citation: Vansteenkiste J, Rochette F, Demedts M. Diagnostic tests of hyperventilation syndrome. Eur Respir J. 1991 Apr;4(4):393-9.
citation: Nixon PG. Effort syndrome: hyperventilation and reduction of anaerobic threshold. Biofeedback Self Regul. 1994 Jun;19(2):155-69. doi: 10.1007/BF01776488.
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.
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.
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.
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.
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;2013(5):CD009041. doi: 10.1002/14651858.CD009041.pub2.