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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

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]

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

Condition category

Condition code

Respiratory

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]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

Comparator/Control group.
Group 1: Exercise
Standardised exercise regime.

Control group

Active

Outcomes

Primary outcome [1]

Change in lung function as measured by spirometry.

Timepoint [1]

Baseline
3 weeks (end of intervention)
6 weeks (3 weeks post-intervention)
9 weeks (6 weeks post-intervention)

Primary outcome [2]

Change in chest expansion as measured by tape measure.

Timepoint [2]

Baseline
3 weeks (end of intervention)
6 weeks (3 weeks post-intervention)
9 weeks (6 weeks post-intervention)

Primary outcome [3]

Change in quality of life as measured by SF-36.

Timepoint [3]

Baseline
3 weeks (end of intervention)
6 weeks (3 weeks post-intervention)
9 weeks (6 weeks post-intervention)

Secondary outcome [1]

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]

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]

2480 - Lismore

Recruitment postcode(s) [2]

4225 - Coolangatta

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Osteopathy Australia

Address [1]

4/11 Railway St, Chatswood NSW 2067

Country [1]

Australia

Primary sponsor type

University

Name

Southern Cross University

Address

PO Box 157
Lismore
NSW 2480

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Macquarie University

Address [1]

Balaclava Road
North Ryde
NSW 2109

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SCU Human Research Ethics Committee (HREC)

Ethics committee address [1]

PO Box 157
Lismore 
NSW 2480

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/07/2016

Approval date [1]

13/09/2016

Ethics approval number [1]

ECN-16-211

Ethics committee name [2]

Macquarie University HREC

Ethics committee address [2]

Research Office
Research Hub, Building C5C East
Macquarie University
NSW 2109

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

04/05/2017

Approval date [2]

07/06/2017

Ethics approval number [2]

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]

/AnzctrAttachments/371507-Protocol Version 2 10 September 2016.docx (Protocol)

Attachments [2]

/AnzctrAttachments/371507-ECN-16-211 NEAF Approval.pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/371507-Consent Form.doc (Participant information/consent)

Attachments [4]

/AnzctrAttachments/371507-Information Sheet.doc (Participant information/consent)

Contacts

Principal investigator

Name

Dr Roger Engel

Address

Department of Chiropractic
Macquarie University
Building C5C, Room 354
Balaclava Road
North Ryde NSW 2109

Country

Australia

Phone

+61 2 9850 6387

Fax

+61 2 9850 9389

roger.engel@mq.edu.au

Contact person for public queries

Name

Sandra Grace

Address

School of Health and Human Sciences
Southern Cross University
PO Box 157
Lismore NSW 2480

Country

Australia

Phone

+61 2 6620 3646

Fax

+61 2 6620 3700

sandra.grace@scu.edu.au

Contact person for scientific queries

Name

Roger Engel

Address

Department of Chiropractic
Macquarie University
Building C5C, Room 354
Balaclava Road
North Ryde NSW 2109

Country

Australia

Phone

+61 2 9850 6387

Fax

+61 2 9850 9389

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

Source	Title	Year of Publication	DOI
Embase	The effect of manual therapy and exercise on age-related lung function: Study protocol for a randomised controlled trial.	2019	https://dx.doi.org/10.1186/s13063-019-3257-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically