Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001317482
Ethics application status
Approved
Date submitted
16/09/2016
Date registered
20/09/2016
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Date results information initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of manual therapy and exercise on age-dependent lung function: a randomised controlled trial.
Scientific title
The effect of manual therapy and exercise on age-dependent lung function: a randomised controlled trial.
Secondary ID [1] 290168 0
None
Universal Trial Number (UTN)
U1111-1187-6962
Trial acronym
The MELT trial
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Lung function 300302 0
Condition category
Condition code
Respiratory 300166 300166 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention groups:
Group 1: Exercise
Group 2: Thoracic mobilisation + exercise
Group 3: Thoracic manipulation + exercise

Exercise will involve a standardised 10 minute treadmill walking program at a speed and inclination that is considered 'comfortable' for the participant.

Thoracic mobilisation will involve soft tissue therapy followed by a joint mobilisation protocol administered to the muscles of the posterior chest wall and the thoracic spine T2-T12), costo-vertebral and costo-transverse joints (2nd-10th) respectively. This protocol will include 5 minutes of soft tissue therapy to the muscles of the posterior chest wall followed by 5 repetitions of joint mobilisation (Maitland Grades III-IV) in each of the following 4 directions: flexion/extension, left and right rotation, left and right transverse, and left and right ribs. The total time for a mobilisation session is 15 minutes.

Thoracic manipulation will involve soft tissue therapy followed by a joint manipulation protocol administered to the muscles of the posterior chest wall and the thoracic spine T2-T12), costo-vertebral and costo-transverse joints (2nd-10th) respectively. This protocol will include 5 minutes of soft tissue therapy to the muscles of the posterior chest wall followed by 2 manipulations (Maitland Grade V) administered to the upper/middle and middle/lower thoracic spine and ribs. Each manipulation will be administered as a 'group' manipulation that involves multiple thoracic inter-vertebral, cost-vertebral and costo-transverse joints The total time for a mobilisation session is 15 minutes.

A register of attendance at the intervention sessions (exercise, mobilisation and manipulation) will be kept for each participant.

Masters of Osteopathy interns will deliver mobilisation and manipulation intervention.
Master of Clinical Exercise Physiology interns will supervise exercise performance.

All three interventions will be administered 6 times over a 3 week period @ 2 times per week.

The trial will be conducted in Southern Cross University's Lismore and Gold Coast Health Clinics.
Intervention code [1] 295926 0
Prevention
Intervention code [2] 295931 0
Treatment: Other
Comparator / control treatment
Comparator/Control group.
Group 1: Exercise
Standardised exercise regime.
Control group
Active

Outcomes
Primary outcome [1] 299656 0
Change in lung function as measured by spirometry.
Timepoint [1] 299656 0
Baseline
3 weeks (end of intervention)
6 weeks (3 weeks post-intervention)
9 weeks (6 weeks post-intervention)
Primary outcome [2] 299657 0
Change in chest expansion as measured by tape measure.
Timepoint [2] 299657 0
Baseline
3 weeks (end of intervention)
6 weeks (3 weeks post-intervention)
9 weeks (6 weeks post-intervention)
Primary outcome [3] 299658 0
Change in quality of life as measured by SF-36.
Timepoint [3] 299658 0
Baseline
3 weeks (end of intervention)
6 weeks (3 weeks post-intervention)
9 weeks (6 weeks post-intervention)
Secondary outcome [1] 327761 0
Occurrence of adverse event following mobilisation or manipulation intervention.
Known adverse events include localised muscle soreness and/or pain, restriction in movement, radiating pain or bone fracture. The presence of these will be assessed through self-reporting by participant in the study and confirmed on X-Ray where appropriate.
Timepoint [1] 327761 0
Each of the 6 intervention sessions (weeks 1-3).
Sessions occur twice a week for 3 weeks.

Eligibility
Key inclusion criteria
i. No history of respiratory disease
ii. Currently non-smoking (preceding 6 months)
iii. Able to walk unaided and unassisted on a treadmill for 10 minutes
Minimum age
50 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
i. Inability to walk unaided and unassisted on a treadmill
ii. Contra-indication to thoracic manual therapy (mobilisation/manipulation)
Osteoporosis
Thoracic joint instability
Acute pain on thoracic joint range of motion testing
Below normal chest wall musculature for age and gender
High level of anxiety related to receiving thoracic spinal mobilisation or manipulation
iii. Inability to understand English
iv. People with a cognitive impairment, an intellectual disability or a mental illness

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
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 sample size for difference for any of the interventions = 112 per group
Minimum cohort size (i.e. 3 groups) is 3 x 112 = 336
Assuming a drop-out rate = 10%
Minimum cohort size = 372 (3 Groups @ 124)

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 144 participants showed no difference in outcomes across groups so primary hypothesis disproved.
Date of first participant enrolment
Anticipated
20/10/2016
Actual
4/11/2016
Date of last participant enrolment
Anticipated
29/06/2018
Actual
14/12/2017
Date of last data collection
Anticipated
31/08/2018
Actual
1/03/2018
Sample size
Target
306
Accrual to date
Final
144
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 14332 0
2480 - Lismore
Recruitment postcode(s) [2] 14334 0
4225 - Coolangatta

Funding & Sponsors
Funding source category [1] 294536 0
Commercial sector/Industry
Name [1] 294536 0
Osteopathy Australia
Country [1] 294536 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
PO Box 157
Lismore
NSW 2480
Country
Australia
Secondary sponsor category [1] 293407 0
University
Name [1] 293407 0
Macquarie University
Address [1] 293407 0
Balaclava Road
North Ryde
NSW 2109
Country [1] 293407 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295973 0
SCU Human Research Ethics Committee (HREC)
Ethics committee address [1] 295973 0
PO Box 157
Lismore
NSW 2480
Ethics committee country [1] 295973 0
Australia
Date submitted for ethics approval [1] 295973 0
24/07/2016
Approval date [1] 295973 0
13/09/2016
Ethics approval number [1] 295973 0
ECN-16-211
Ethics committee name [2] 298465 0
Macquarie University HREC
Ethics committee address [2] 298465 0
Research Office
Research Hub, Building C5C East
Macquarie University
NSW 2109
Ethics committee country [2] 298465 0
Australia
Date submitted for ethics approval [2] 298465 0
04/05/2017
Approval date [2] 298465 0
07/06/2017
Ethics approval number [2] 298465 0
5201700554

Summary
Brief summary
Ageing is associated with a range of anatomical and physiological changes that include the respiratory system. These changes begin as early as 40 years of age and include stiffening of the spine and chest wall. This stiffening has an impact on breathing mechanics and is a cause of the progressive decline in lung function typically associated with ageing. The aim of this trial is to investigate whether reducing stiffness in the spine and chest wall improves lung function in people over 50 years of age. The trial is designed as a randomised controlled trial with 306 healthy people between the ages of 50 and 65 years randomly allocated to one of three equal groups.
Group 1 (Control) will receive a standardised exercise program performed on a
treadmill.
Group 2 will receive a mobilisation protocol designed to increase joint mobility in the
thoracic spine and ribs followed by the same exercise program.
Group 3 will receive a manipulation protocol designed to increase joint mobility in the thoracic spine and ribs followed by the same exercise program.
Each participant will receive six intervention sessions over a period of three weeks. Outcome measurements will be taken by assessors who are unaware of
the group a participant has been allocated to. They include non-invasive lung function
measurements, chest expansion and a respiratory function questionnaire. These
measurements will be taken on four occasions: before the first intervention (baseline), at the end of the intervention period (3 weeks), and then at 3 and 6 weeks post-intervention (i.e. in the 6th and 9th weeks of the trial). The last two measuring points are designed to assess whether the effects of intervention are ongoing. Lung function will be measured using spirometry (exhaling into a tube) and chest expansion measured using a tape measure. It is expected that manual therapy plus exercise will improve lung function more than exercise alone. It is also expected that improvements in lung function will be different for the two manual therapy interventions.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1113 1113 0 0
/AnzctrAttachments/371507-Protocol Version 2 10 September 2016.docx (Protocol)
Attachments [2] 1114 1114 0 0
/AnzctrAttachments/371507-ECN-16-211 NEAF Approval.pdf (Ethics approval)
Attachments [3] 1115 1115 0 0
/AnzctrAttachments/371507-Consent Form.doc (Participant information/consent)
Attachments [4] 1116 1116 0 0
/AnzctrAttachments/371507-Information Sheet.doc (Participant information/consent)

Contacts
Principal investigator
Name 69086 0
Dr Roger Engel
Address 69086 0
Department of Chiropractic
Macquarie University
Building C5C, Room 354
Balaclava Road
North Ryde NSW 2109
Country 69086 0
Australia
Phone 69086 0
+61 2 9850 6387
Fax 69086 0
+61 2 9850 9389
Email 69086 0
roger.engel@mq.edu.au
Contact person for public queries
Name 69087 0
A/Prof Sandra Grace
Address 69087 0
School of Health and Human Sciences
Southern Cross University
PO Box 157
Lismore NSW 2480
Country 69087 0
Australia
Phone 69087 0
+61 2 6620 3646
Fax 69087 0
+61 2 6620 3700
Email 69087 0
sandra.grace@scu.edu.au
Contact person for scientific queries
Name 69088 0
Dr Roger Engel
Address 69088 0
Department of Chiropractic
Macquarie University
Building C5C, Room 354
Balaclava Road
North Ryde NSW 2109
Country 69088 0
Australia
Phone 69088 0
+61 2 9850 6387
Fax 69088 0
+61 2 9850 9389
Email 69088 0
roger.engel@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data
When will data be available (start and end dates)?
Data will be available from 14/12/18 to 30/11/2019.
Available to whom?
All researchers on application.
Available for what types of analyses?
For meta-analysis.
How or where can data be obtained?
Attached as data file to article.


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
EmbaseThe effect of manual therapy and exercise on age-related lung function: Study protocol for a randomised controlled trial.2019https://dx.doi.org/10.1186/s13063-019-3257-z
N.B. These documents automatically identified may not have been verified by the study sponsor.