Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000766617
Ethics application status
Approved
Date submitted
10/07/2014
Date registered
18/07/2014
Date last updated
9/04/2019
Date data sharing statement initially provided
9/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of combining manual therapy with exercise for stable mild chronic obstructive pulmonary disease: a
randomised controlled trial
Scientific title
The effect of combining manual therapy with exercise for stable mild chronic obstructive pulmonary disease: a
randomised controlled trial
Secondary ID [1] 284955 0
Nil known
Universal Trial Number (UTN)
U1111-1159-3374
Trial acronym
MT COPD trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 292441 0
Condition category
Condition code
Respiratory 292753 292753 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Exercise
Arm 2: Manual therapy and exercise

Exercise: 36 x 30 minute exercise sessions over an 18 week period at an average rate of 2x/week. Administered by respiratory physiotherapists. Exercise consists of gentle aerobic exercise routines.
Manual Therapy: 15 x 20 minute manual therapy sessions over a 6 week period at an average rate of 2-3x/week. Administered by chiropractors and/or osteopaths. Manual therapy consists of massage and thoracic spinal manipulation.
Intervention code [1] 289782 0
Treatment: Other
Comparator / control treatment
Active Control: Standardised exercise regime for COPD.
This program is the exercise component of the existing pulmonary rehabilitation program at Sutherland Hospital. It consists of a mix of aerobic, resistance & flexibility exercises performed at moderate intensity
Control group
Active

Outcomes
Primary outcome [1] 292601 0
Lung function assessed by spirometry
Timepoint [1] 292601 0
Baseline, 4, 8, 16, 24, 32, and 48 weeks
Secondary outcome [1] 309313 0
Exercise capacity as measured by 6 minute walking test
Timepoint [1] 309313 0
Baseline, 4, 8, 16, 24, 32 and 48 weeks
Secondary outcome [2] 309314 0
C-Reactive protein and leukocyte levels assessed through blood samples (10ml)
Timepoint [2] 309314 0
Baseline, 4, 8, 24 and 48 weeks
Secondary outcome [3] 309496 0
Quality of Life measured by St Georges Respiratory Questionnaire (SGRQ) and Hospital of Anxiety and Depression (HAD) scale.
Timepoint [3] 309496 0
Baseline, 4, 8, 16, 24, 32 and 48 weeks

Eligibility
Key inclusion criteria
1. Existing diagnosis of mild COPD (60% < FEV1 < 80%)
2. Stable COPD (no exacerbations for preceding 6 months)
3. Current non-smoker (non-smoking for > 6 months)
Minimum age
50 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to complete 6 minute walking test unassisted
2. History of auto-immune disease that may have permanently altered systemic inflammatory biomarkers
3. Contra-indication for thoracic spinal manipulation (Bone density T score < -2.5 and/or Z score < -1)
4. Thoracic joint instability
5. Acute pain on thoracic joint range of motion testing
6. Below normal chest wall musculature for age and gender
7. High level of anxiety related to receiving thoracic spinal manipulation
8. Completed a pulmonary rehabilitation program within the previous 12 months

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)
Volunteers, who meet the inclusion criteria will be given an information sheet and asked to sign the consent form. They will then undergo a screening for contra-indications to
thoracic spinal manipulation. After a volunteer has passed the screening test they will be enrolled in the trial and given a trial specific ID number. Baseline measurements for each participant will then be taken. Participants will then be allocated to one of the two trial groups according to a computer generated random number sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation

Minimum clinically important difference in lung volume (FVC) = 200 ml
Standard deviation = 480ml (obtained from previous studies)
Power = 0.8 (80%)
Alpha = 0.05
Minimum sample size for two sample t-test = 92 per group
Minimum cohort size (i.e. 2 groups) is 2 x 92 = 184
Assuming a drop-out rate = 10%
Minimum cohort size = 202 (2 Groups @ 101)

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Interim analysis of 24 week data of first 60 participants showed no difference between groups.
Date of first participant enrolment
Anticipated
21/07/2014
Actual
4/11/2014
Date of last participant enrolment
Anticipated
20/07/2018
Actual
20/05/2018
Date of last data collection
Anticipated
20/06/2019
Actual
Sample size
Target
202
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2713 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 8424 0
2228 - Miranda

Funding & Sponsors
Funding source category [1] 289581 0
Commercial sector/Industry
Name [1] 289581 0
Chiropractors Association of Australia (NSW)
Country [1] 289581 0
Australia
Funding source category [2] 293721 0
Hospital
Name [2] 293721 0
St George & Sutherland Medical Research Foundation
Country [2] 293721 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road
North Ryde
NSW 2109
Country
Australia
Secondary sponsor category [1] 288265 0
Hospital
Name [1] 288265 0
Sutherland Hospital
Address [1] 288265 0
126 Kareena Road
Miranda
NSW 2228
Country [1] 288265 0
Australia
Secondary sponsor category [2] 288266 0
Individual
Name [2] 288266 0
Associate Professor Subramanyam Vemulpad
Address [2] 288266 0
Department of Chiropractic
Building C5C Room 351
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country [2] 288266 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291317 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 291317 0
Ethics committee country [1] 291317 0
Australia
Date submitted for ethics approval [1] 291317 0
Approval date [1] 291317 0
23/06/2014
Ethics approval number [1] 291317 0
13/004

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

Contacts
Principal investigator
Name 49826 0
Dr Roger Engel
Address 49826 0
Department of Chiropractic Room 354, 17 Wally's Walk Macquarie University Balaclava Road North Ryde NSW 2109
Country 49826 0
Australia
Phone 49826 0
+61 2 98506387
Fax 49826 0
+61 2 98509389
Email 49826 0
[email protected]
Contact person for public queries
Name 49827 0
Roger Engel
Address 49827 0
Department of Chiropractic
Building C5C Room 354
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country 49827 0
Australia
Phone 49827 0
+61 2 98506387
Fax 49827 0
+61 2 98509389
Email 49827 0
[email protected]
Contact person for scientific queries
Name 49828 0
Roger Engel
Address 49828 0
Department of Chiropractic
Building C5C Room 354
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country 49828 0
Australia
Phone 49828 0
+61 2 98506387
Fax 49828 0
+61 2 98509389
Email 49828 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Didn't receive consent for sharing data in ethics approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1823Study protocol    366692-(Uploaded-09-04-2019-10-42-50)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of combining manual therapy with exercise for mild chronic obstructive pulmonary disease: Study protocol for a randomised controlled trial.2017https://dx.doi.org/10.1186/s13063-017-2027-z
N.B. These documents automatically identified may not have been verified by the study sponsor.