Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000388415
Ethics application status
Approved
Date submitted
23/07/2007
Date registered
24/07/2007
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of massage and joint mobilisation in the management of long term breathing problems
Scientific title
The effect of including spinal manipulation in the management of chronic obstructive pulmonary disease within a standardised pulmonary rehabilitation program
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emphysema, chronic bronchitis 1970 0
Condition category
Condition code
Respiratory 2068 2068 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: massage (15 minutes), spinal manipulation (5 minutes) at 2 x week for 8 weeks
Intervention code [1] 1903 0
Treatment: Other
Comparator / control treatment
Comparator: pulmonary rehabilitation exercise program (treadmill walking, fixed cycling, free and fixed weight training, simple floor exercises) at 2 x week for 16 weeks
Control group
Active

Outcomes
Primary outcome [1] 3153 0
Spirometry
Timepoint [1] 3153 0
At initial and 4 week intervals
Primary outcome [2] 3154 0
Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1st second (FEV-1)
Timepoint [2] 3154 0
At initial and 4 week intervals
Primary outcome [3] 3155 0
FVC/FEV1 ratio
Timepoint [3] 3155 0
At initial and 4 week intervals
Primary outcome [4] 3156 0
Oxygen saturation
Timepoint [4] 3156 0
At initial and 4 week intervals
Primary outcome [5] 3157 0
Heart rate
Timepoint [5] 3157 0
At initial and 4 week intervals
Primary outcome [6] 3158 0
6 Minute Walking Test: Distance
Timepoint [6] 3158 0
At initial and 4 week intervals
Secondary outcome [1] 4897 0
Hospital Anxiety Depression (HAD) scale
Timepoint [1] 4897 0
At initial assessment and end of trial (16 weeks).
Secondary outcome [2] 4898 0
St George's Respiratory Questionnaire
Timepoint [2] 4898 0
At initial assessment and end of trial (16 weeks).

Eligibility
Key inclusion criteria
Referral to the Sutherland heart & lung health team (SHALT) pulmonary rehabilitation exercise program at Sutherland Hospital; non-smoking for 12 months.
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-ambulatory; bone density readings of a T score <-2.5 and/or a Z score < -1; the presence of any contra-indication to spinal manipulation of the thoracic spine and/or posterior rib articulations.

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 to intervention groups was concealed by using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation was done by simple randomisation using coin-tossing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/07/2007
Actual
23/07/2007
Date of last participant enrolment
Anticipated
Actual
24/04/2009
Date of last data collection
Anticipated
Actual
20/07/2009
Sample size
Target
45
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 2214 0
University
Name [1] 2214 0
Macquarie University
Country [1] 2214 0
Australia
Primary sponsor type
Individual
Name
Roger Engel
Address
Balaclava Road North Ryde NSW 2109
Country
Australia
Secondary sponsor category [1] 1997 0
Individual
Name [1] 1997 0
Peter Gonski - SOUTHCARE Sutherland Hospital, Sydney. Australia
Address [1] 1997 0
126 Kareena Road Miranda NSW 2228
Country [1] 1997 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4050 0
Macquarie University Ethics Review Committee (Human Research)
Ethics committee address [1] 4050 0
Ethics committee country [1] 4050 0
Australia
Date submitted for ethics approval [1] 4050 0
Approval date [1] 4050 0
30/03/2007
Ethics approval number [1] 4050 0
HE23MAR2007-D05054
Ethics committee name [2] 4051 0
South Eastern Sydney Illawara Human Research Ethics Committee
Ethics committee address [2] 4051 0
Ethics committee country [2] 4051 0
Australia
Date submitted for ethics approval [2] 4051 0
Approval date [2] 4051 0
11/07/2007
Ethics approval number [2] 4051 0
07/41 Engel

Summary
Brief summary
The rib cage, spine and muscles of the chest wall play an important role in breathing. Pulmonary rehabilitation exercise programs have been shown to improve pulmonary function and quality of life in people suffering from emphysema and/or chronic bronchitis. This trial tests a new treatment aimed at improving the outcomes of an existing pulmonary rehabilitation exercise program. Massage and joint mobilisation will be applied to the joints and muscles of the chest wall in people undertaking a standardised pulmonary rehabilitation exercise program in an attempt to increase the improvement in lung function normally associated with such programs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27717 0
Dr Roger Engel
Address 27717 0
Room 354, 17 Wally's Walk
Balaclava Road
North Ryde
Macquarie University
Country 27717 0
Australia
Phone 27717 0
+61298506387
Fax 27717 0
Email 27717 0
[email protected]
Contact person for public queries
Name 11092 0
Roger Engel
Address 11092 0
Department of Chiropractic
Macquarie University NSW 2109
Country 11092 0
Australia
Phone 11092 0
+61 2 9850 6387
Fax 11092 0
+61 2 9850 9389
Email 11092 0
[email protected]
Contact person for scientific queries
Name 2020 0
Roger Engel
Address 2020 0
Department of Chiropractic
Macquarie University NSW 2109
Country 2020 0
Australia
Phone 2020 0
+61 2 9850 6387
Fax 2020 0
+61 2 9850 9389
Email 2020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Full de-identified data set
When will data be available (start and end dates)?
01/01/2017 - 31/12/2018
Available to whom?
All researchers on application
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Excel data file.


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
No additional documents have been identified.