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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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)
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 3
Type of endpoint(s)
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 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
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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)
Address [1] 289581 0
P.O. Box 61
St Leonards
NSW 1590
Country [1] 289581 0
Funding source category [2] 293721 0
Name [2] 293721 0
St George & Sutherland Medical Research Foundation
Address [2] 293721 0
Suite 8/13 Hogben Street, KOGARAH NSW 2217
Country [2] 293721 0
Primary sponsor type
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Secondary sponsor category [1] 288265 0
Name [1] 288265 0
Sutherland Hospital
Address [1] 288265 0
126 Kareena Road
NSW 2228
Country [1] 288265 0
Secondary sponsor category [2] 288266 0
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

Ethics approval
Ethics application status
Ethics committee name [1] 291317 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 291317 0
Room G71 East Wing
Edmund Blackett Building
Prince of Wales Hospital
Ethics committee country [1] 291317 0
Date submitted for ethics approval [1] 291317 0
Approval date [1] 291317 0
Ethics approval number [1] 291317 0

Brief summary
The aim of this study is to measure the medium to long term effects on lung function, exercise capacity and quality of life of a new combination of interventions for people with COPD. The interventions are manual therapy and exercise. The rationale behind the study is that manual therapy delivers short-term improvements in respiratory mechanics which delays the onset of exercise-induced breathlessness. This permits an increase in exercise performance and ultimately exercise capacity. As exercise capacity is an indicator of mortality in COPD, any increase represents an improvement in the long-term prognosis of the disease.
Trial website
Trial related presentations / publications
Engel RM, Vemulpad S, Beath K. Short term effects of combining manual therapy and exercise on moderate chronic obstructive pulmonary disease (COPD): a randomized pilot study. Journal of Manipulative Physiological Therapeutics, 2013. 36: p. 490-496.

Engel RM, Gonski P, Beath K, Vemulpad S. Medium term effects of including manual therapy in a pulmonary rehabilitation program for chronic obstructive pulmonary disease (COPD): a randomized controlled pilot trial. Journal of Manual and Manipulative Therapies. 2014. doi: 10.1179/2042618614Y.0000000074.
Public notes

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
Phone 49826 0
+61 2 98506387
Fax 49826 0
+61 2 98509389
Email 49826 0
Contact person for public queries
Name 49827 0
Dr Roger Engel
Address 49827 0
Department of Chiropractic
Building C5C Room 354
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country 49827 0
Phone 49827 0
+61 2 98506387
Fax 49827 0
+61 2 98509389
Email 49827 0
Contact person for scientific queries
Name 49828 0
Dr Roger Engel
Address 49828 0
Department of Chiropractic
Building C5C Room 354
Macquarie University
Balaclava Road
North Ryde
NSW 2109
Country 49828 0
Phone 49828 0
+61 2 98506387
Fax 49828 0
+61 2 98509389
Email 49828 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
Didn't receive consent for sharing data in ethics approval.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 1823 0
Study protocol
Citation [1] 1823 0
Link [1] 1823 0
Email [1] 1823 0
Other [1] 1823 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary