NCT00895219

Brief Summary

Traditionally, the physiotherapy management of people with dysfunctional breathing or hyperventilation syndrome is breathing re-training. There is increasing clinical evidence that structural and functional changes develop in the muscles and connective tissues of the chest wall, abdomen and back when the upper chest accessory pattern of breathing is used over time. When treatment includes breathing techniques only it is difficult for a person with chronic hyperventilation, who has developed muscle and connective tissue changes, to revert to using the normal lower chest diaphragmatic breathing pattern. In clinical practice when the problems which have developed in the musculoskeletal system are addressed, the patient reverts more quickly to the lower chest pattern of breathing but there is as yet little evidence to support this clinical finding.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 8, 2009

Status Verified

April 1, 2009

Enrollment Period

2 years

First QC Date

May 7, 2009

Last Update Submit

May 7, 2009

Conditions

Keywords

HyperventilationDysfunctional breathingPhysiotherapyMusculoskeletal techniques

Outcome Measures

Primary Outcomes (1)

  • Nijmegen Questionnaire

    0, 2, 4, 8, 12 and 26 weeks

Secondary Outcomes (1)

  • Six-minute walking test

    0, 2, 4, 8, 12 & 26 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Breathing re-training

Other: Breathing re-training

2

ACTIVE COMPARATOR

Breathing re-training and musculoskeletal physiotherapy techniques

Other: Breathing re-training and musculoskeletal techniques

Interventions

Breathing re-training

1

Breathing re-training and musculoskeletal physiotherapy techniques including mobilisation techniques to normalise muscle and joint restrictions, doming of the diaphragm to enhance contraction and relaxation, and rib raising to free restriction in rib cage motion.

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of dysfunctional breathing (Nijmegen score of more than 23)

You may not qualify if:

  • active metastatic disease
  • osteoporotic disease
  • dysfunctional breathing as a consequence of respiratory or cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Hyperventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Margaret E Hodson, MD

    Royal Brompton & Harefield NHS Foundation Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

July 1, 2007

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

May 8, 2009

Record last verified: 2009-04

Locations