Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000518369
Ethics application status
Approved
Date submitted
26/09/2008
Date registered
2/10/2008
Date last updated
9/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of spinal manipulation on lung function in asymptomatic people with a history of respiratory disease
Scientific title
The effect of spinal manipulation on lung function in asymptomatic people with a history of respiratory disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung function in individuals 'at risk' of developing chronic obstructive pulmonary disease (COPD stage 0) 3754 0
Condition category
Condition code
Respiratory 3933 3933 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
therapeutic massage to the posterior thoracic muscles for 15 minutes, spinal manipulation of the thoracic vertebral and costal joints for 5 minutes, standardised 6 minute walking treadmill exercise routine 3 x week for 3 weeks. All participants receive exercise; half of the participants receive massage and spinal manipulation before exercise
Intervention code [1] 3467 0
Prevention
Comparator / control treatment
Exercise 3 x week for 3 weeks: 6 minute standardised treadmill walking
Control group
Active

Outcomes
Primary outcome [1] 4829 0
Primary outcome 1: spirometry measurements of forced vital capacity (FVC) & forced expiratory volume in 1st second (FEV1)
Timepoint [1] 4829 0
Timepoints: pre and post intervention session i.e 3 x week over 3 weeks
Primary outcome [2] 4830 0
Primary outcome 2: respiratory inductive plethysmography
Timepoint [2] 4830 0
Timepoints: pre and post intervention session i.e 3 x week over 3 weeks
Secondary outcome [1] 8150 0
Total change in lung function via spirometry (initial and final FVC & FEV1)
Timepoint [1] 8150 0
at initial and final interventions and 3 weeks post intervention i.e. 6 weeks after initial intervention

Eligibility
Key inclusion criteria
History of respiratory disease
Below normal spirometry
Ambulatory
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current respiratory disease
Non-ambulatory
Contra-indicated to spinal manipulation

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3929 0
University
Name [1] 3929 0
Macquarie University
Country [1] 3929 0
Australia
Primary sponsor type
Individual
Name
Roger Engel
Address
Department of Health & Chiropractic
Macquarie University
Sydney
New South Wales 2109
Country
Australia
Secondary sponsor category [1] 3523 0
None
Name [1] 3523 0
Address [1] 3523 0
Country [1] 3523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5994 0
Macquarie University Ethics Review Committee (Human Research)
Ethics committee address [1] 5994 0
Macquarie University
Sydney
New South Wales 2109
Ethics committee country [1] 5994 0
Australia
Date submitted for ethics approval [1] 5994 0
Approval date [1] 5994 0
30/05/2008
Ethics approval number [1] 5994 0
HE30MAY2008-D05923

Summary
Brief summary
The aim of this project is to investigate the relationship between the spine, rib cage and associated muscles and lung function following the administration of spinal manipulation and exercise. The project will be conducted on healthy people with a previous history of respiratory disease who have either normal or below normal current lung function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28979 0
Address 28979 0
Country 28979 0
Phone 28979 0
Fax 28979 0
Email 28979 0
Contact person for public queries
Name 12136 0
Roger Engel
Address 12136 0
Department of Health & Chiropractic
Macquarie University
Sydney
New South Wales 2109
Country 12136 0
Australia
Phone 12136 0
+61 2 9850 6387
Fax 12136 0
+61 2 9850 9389
Email 12136 0
[email protected]
Contact person for scientific queries
Name 3064 0
Roger Engel
Address 3064 0
Department of Health & Chiropractic
Macquarie University
Sydney
New South Wales 2109
Country 3064 0
Australia
Phone 3064 0
+61 2 9850 6387
Fax 3064 0
+61 2 9850 9389
Email 3064 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
No additional documents have been identified.