ClinicalTrials.gg
Status unknownNCT00895219HVSUpdated May 8, 2009

Physiotherapy and Dysfunctional Breathing

A Phase 3 interventional study of Breathing re-training and Breathing re-training and musculoskeletal techniques in Hyperventilation, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2009-05-08.

Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperventilation

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Keywords

  • Hyperventilation
  • Dysfunctional breathing
  • Physiotherapy
  • Musculoskeletal techniques
03

In context

Hyperventilation

43 studies on the registry are indexed under Hyperventilation; 6 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 31 interventional studies indexed under Hyperventilation.

Browse Hyperventilation studies →

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 141 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • active disease
  • osteoporotic disease
  • dysfunctional breathing as a consequence of respiratory or cardiac disease
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    1

    Breathing re-training

    Other: Breathing re-training

  • Active comparator
    2

    Breathing re-training and musculoskeletal physiotherapy techniques

    Other: Breathing re-training and musculoskeletal techniques

Interventions

  • OtherBreathing re-training

    Breathing re-training

  • OtherBreathing re-training and musculoskeletal techniques

    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.

06

What researchers measure

Primary outcomes

  1. Nijmegen Questionnaire

    Time frame: 0, 2, 4, 8, 12 and 26 weeks

Secondary outcomes

  1. Six-minute walking test

    Time frame: 0, 2, 4, 8, 12 & 26 weeks

07

Study locations

1 site
  • Royal Brompton Hospital
    London, SW3 6NP, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2007, a primary completion of Jul 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2009
First posted
May 8, 2009
Start
Jul 2007
Primary completionEst.
Jul 2009
CompletionEst.
Dec 2009
Last update
May 8, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00895219
First posted
May 8, 2009
Start date
Jul 2007
Primary completion
Jul 2009 (estimated)
Completion
Dec 2009 (estimated)
Last update
May 8, 2009

Study contacts

Margaret E Hodson, MD
study director · Royal Brompton & Harefield NHS Foundation Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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