Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001119684
Ethics application status
Approved
Date submitted
3/10/2014
Date registered
22/10/2014
Date last updated
16/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of osteopathic manual therapy with breathing re-training on dysfunctional breathing, exercise economy and the autonomic nervous system
Scientific title
The effect of osteopathic manual therapy with breathing re-training on symptoms of dysfunctional breathing, exercise economy and heart rate variability in active adults
Secondary ID [1] 285181 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysfunctional Breathing 292779 0
Condition category
Condition code
Respiratory 293075 293075 0 0
Other respiratory disorders / diseases
Neurological 293076 293076 0 0
Studies of the normal brain and nervous system
Physical Medicine / Rehabilitation 293570 293570 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Osteopathic Manual Therapy + Breathing Re-training

Osteopathic Manual Therapy is provided by qualified, experienced osteopaths. Therapy will entail a semi-structured 30-minute osteopathy treatment administered weekly for 4 weeks. Treatment will consist of a selection of manual techniques applied mainly to the neck, thorax, lower back and abdomen with postural advice if indicated.

For breathing re-training, participants will be instructed through an individually-paced, progressive programme. Final year osteopathy students will assess the breathing function of participants at study onset and provide instruction for breathing re-training techniques in a 15-minute session. Participants will be asked to practice these techniques as often as possible, incorporated into their normal daily activities, but at least for 10 minutes, 2x per day for 4 weeks. They will also have access to an online video demonstrating these techniques that they can refer to.

Compliance to the breathing retraining will be retrospectively monitored weekly by osteopath practitioners. Practitioners will complete standardised treatment notes for each osteopathy treatment session. Both the structural changes and breathing retraining outcomes will be monitored.
Intervention code [1] 290038 0
Rehabilitation
Intervention code [2] 290041 0
Treatment: Other
Intervention code [3] 290042 0
Behaviour
Comparator / control treatment
Participants are randomised to immediate or 4-week delayed start of treatment. The group randomised to delayed start will act as a control group for the period of the delay.
Control group
Active

Outcomes
Primary outcome [1] 292938 0
Self-Evaluation of Breathing Questionnaire (SEBQ)
Timepoint [1] 292938 0
4 weeks
Primary outcome [2] 292939 0
Exercise Economy at 3 individually-prescribed workloads

Workload intensity will be determined from a prior VO2max test completed on a cycle ergometer. After completing a 5-minute warm-up, participants will complete 3, 5-minute cycling exercise bouts at individually-prescribed workloads, undertaken consecutively without rest, at a constant pedal cadence of 70 revolutions per minute, and equating to approximately 40%, 55% and 70% of VO2max.

Exercise economy will be assessed by quantifying average oxygen consumption in the final 3 minutes of each exercise bout, measured using a Moxus metabolic cart.
Timepoint [2] 292939 0
4 weeks
Primary outcome [3] 292940 0
Resting heart-rate variability

Heart-rate variability will be recorded for 7 days, for 6 minutes upon waking. Data is measured via Polaris RS800 heart rate monitor using Kubios heart-rate variability analysis software.
Timepoint [3] 292940 0
4 weeks
Secondary outcome [1] 309980 0
Nijmegen Questionnaire (for hyperventilation syndrome)
Timepoint [1] 309980 0
4 weeks
Secondary outcome [2] 309982 0
Resting peak expiratory flow rate (PEFR)

Measured via hand-held spirometer.
Timepoint [2] 309982 0
4 weeks
Secondary outcome [3] 309983 0
Resting forced expiratory volume in 1 s (FEV1)

Measured via hand-held spirometer.
Timepoint [3] 309983 0
4 weeks
Secondary outcome [4] 309984 0
Resting forced vital capacity (FVC)

Measured via hand-held spirometer.
Timepoint [4] 309984 0
4 weeks
Secondary outcome [5] 309985 0
Resting upper chest to abdomen breathing distension
Timepoint [5] 309985 0
4 weeks

Assessed via respiratory inductive plethysmography. This device measures the circumference and change in distension of the upper and lower chest.
Secondary outcome [6] 309986 0
Breath-hold time
Timepoint [6] 309986 0
4 weeks

Timed, using a stopwatch, at the end of a normal tidal volume expiration (at functional residual capacity).
Secondary outcome [7] 309987 0
Post-exercise heart rate recovery

Measured, using a Polaris RS800 heart-rate monitor, as change in heart-rate over 3 minutes immediately following the completion of all 3 exercise bouts, whilst sitting stationary on the cycle ergometer.
Timepoint [7] 309987 0
4 weeks
Secondary outcome [8] 310668 0
Resting heart rate

Measured via Polaris RS800 heart-rate monitor as average heart-rate over 7 days, for 6 minutes upon waking.
Timepoint [8] 310668 0
4 weeks
Secondary outcome [9] 310669 0
Resting end tidal CO2

Measured using a Moxus metabolic cart and open-circuit spirometry, for 30 s prior to warm-up whilst sitting stationary on a cycle ergometer.
Timepoint [9] 310669 0
4 weeks
Secondary outcome [10] 310732 0
Borg Ratings of Perceived Exertion (RPE) Scale

Assessed at 3 minutes and 5 minutes of each 5 minute exercise bout at individually-prescribed workloads equating to approximately 40%, 55% and 70% of VO2max, cycling at a constant pedal cadence of 70 revolutions per minute.
Timepoint [10] 310732 0
4 weeks

Eligibility
Key inclusion criteria
*Participate in aerobic exercise for more than 4 hours per week
*Body mass index no less than 18.5 kg/m2 and not greater than 30 kg/m2
*Perceive that breathing may be limiting their sporting performance
*Understand written and verbal English
*Upon screening, exhibit an SEBQ score of 10 or greater
*In a Functional Movement Screen, exhibit a dysfunction in the neck, thoracic or lumbar region
Minimum age
19 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Current smoker or smoked in last 6 months
*Respiratory-related hospitalisations in the last 6 months
*Diagnosed emotional disorders
*Diagnosed cardiac condition or dysfunction
*Diagnosed autonomic nervous system pathology or dysfunction

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was not involved in participant recruitment and not in contact with prospective participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using the website http://www.randomization.org
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants were randomly assigned to 4-week delayed start of treatment, thus creating a randomised controlled trial for the first 4 weeks of treatment. All participants eventually received 4 weeks of treatment. Secondary analysis of the whole cohort was also performed.

Participants were not told that some were being deliberately randomised to a delayed start.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed ANOVA model (1 repeated-measures factor and 1 independent measures factor) for RCT analysis.

Paired t-tests for single cohort analysis.

A sample size of 15 for the entire cohort would be required to detect change effect sizes of 0.8, assuming a level of significance of 0.05 and statistical power of 0.8. An effect size of 0.8 equates to a change of approximately 9 points in SEBQ (Mitchell & Technology, 2011) or 0.2 L/min in VO2 (Bacon, Myers, & Karageorghis, 2012) for economy. Because participants are randomised into two groups, requiring an even number, and some people may not be able to complete the study (Immediate- and Delayed-Start), an initial sample size of 18 is proposed. It is acknowledged that the power to detect differences between the two groups in the RCT analysis allowed by the design is more limited with only 8 participants per group. Nonetheless, an effect size of 1.6, equating to a difference in SEBQ of 18.4 and in economy 0.4 L/min could still be detected.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/10/2014
Actual
16/11/2014
Date of last participant enrolment
Anticipated
2/04/2015
Actual
25/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
19
Recruitment outside Australia
Country [1] 6297 0
New Zealand
State/province [1] 6297 0
Auckland region

Funding & Sponsors
Funding source category [1] 289793 0
University
Name [1] 289793 0
Unitec Institute of Technology
Country [1] 289793 0
New Zealand
Primary sponsor type
University
Name
Unitec Institute of Technology
Address
Carrington Rd, Mt Albert
Private Bag 92025
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 288484 0
None
Name [1] 288484 0
Address [1] 288484 0
Country [1] 288484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291529 0
Unitec Research Ethics Committee
Ethics committee address [1] 291529 0
Ethics committee country [1] 291529 0
New Zealand
Date submitted for ethics approval [1] 291529 0
07/11/2013
Approval date [1] 291529 0
22/05/2014
Ethics approval number [1] 291529 0
2013-1080

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50742 0
Dr Catherine Bacon
Address 50742 0
Unitec Institute of Technology,
Carrington Rd, Mt Albert,
Private Bag 92025
Victoria Street West,
Auckland 1142
Country 50742 0
New Zealand
Phone 50742 0
+64 9 849 6794
Fax 50742 0
Email 50742 0
[email protected]
Contact person for public queries
Name 50743 0
Catherine Bacon
Address 50743 0
Unitec Institute of Technology,
Carrington Rd, Mt Albert,
Private Bag 92025
Victoria Street West,
Auckland 1142
Country 50743 0
New Zealand
Phone 50743 0
+64 9 849 6794
Fax 50743 0
Email 50743 0
[email protected]
Contact person for scientific queries
Name 50744 0
Catherine Bacon
Address 50744 0
Unitec Institute of Technology,
Carrington Rd, Mt Albert,
Private Bag 92025
Victoria Street West,
Auckland 1142
Country 50744 0
New Zealand
Phone 50744 0
+64 9 849 6794
Fax 50744 0
Email 50744 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIPreliminary development of a complex intervention for osteopathic management of dysfunctional breathing2016https://doi.org/10.1016/j.ijosm.2016.04.004
N.B. These documents automatically identified may not have been verified by the study sponsor.