Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12618000889257
Ethics application status
Approved
Date submitted
21/05/2018
Date registered
28/05/2018
Date last updated
28/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity undertaken by people with motor neuron disease. What activities and how much are they doing?
Scientific title
Physical activity undertaken by people with motor neuron disease. What activities and how much are they doing?
Secondary ID [1] 294949 0
None
Universal Trial Number (UTN)
U1111-1214-0205
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor neuron disease 307946 0
Condition category
Condition code
Neurological 306980 306980 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be asked to report what and how much physical activities they have done in the last 7 days. It is a once off questionnaire and should take approximately 10-15 minutes to complete.
Intervention code [1] 301272 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305964 0
Physical Activity Scale for the Elderly (PASE) score
Timepoint [1] 305964 0
First physiotherapy appointment during data collection period.
Secondary outcome [1] 347122 0
Forced vital capacity - measured using spirometry or collected from medical record if available.
Timepoint [1] 347122 0
First physiotherapy appointment during data collection period
Secondary outcome [2] 347129 0
ALSFRS - Revised version. The ALSFRS-R is a composite outcome measure widely used in ALS trials. It comprises of 4 sub-categories: bulbar, fine motor, gross motor and breathing. For this study, only the items in the gross motor section will be asked. These items are:
Item 7: Turning in bed and adjusting bedding
Item 8: Walking
Item 9: Climbing stairs
Timepoint [2] 347129 0
First physiotherapy appointment during the data collection period
Secondary outcome [3] 347290 0
NIV use - assessed by asking participants about their decision regarding NIV implementation and use of it.
Timepoint [3] 347290 0
First physiotherapy appointment during the data collection period.

Eligibility
Key inclusion criteria
Confirmed diagnosis of motor neuron disease
Is able to walk with or without assistance
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No longer able to walk.
Has any other neurological diagnosis

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The data collection will occur over a 12 months period. Any patient meeting the inclusion criteria will be recruited for the study. It is anticipated that we will have approximately 200 participants over this period.

Descriptive statistics will be used to present participant characteristics. Data analysis will determine if a relationship exists between ALSFRS-R scores, NIV use, FVC and physical activity choice.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/06/2018
Actual
Date of last participant enrolment
Anticipated
31/05/2019
Actual
Date of last data collection
Anticipated
31/05/2019
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10951 0
Calvary Health Care Bethlehem Ltd - Caulfield
Recruitment postcode(s) [1] 22732 0
3162 - Caulfield

Funding & Sponsors
Funding source category [1] 299534 0
Hospital
Name [1] 299534 0
Calvary Health Care Bethlehem
Country [1] 299534 0
Australia
Primary sponsor type
Individual
Name
Trinh Nguyen
Address
Physiotherapy Department
Calvary Health Care Bethlehem
476 Kooyong Road
Caulfield South 3162
Country
Australia
Secondary sponsor category [1] 298836 0
Individual
Name [1] 298836 0
Karol Connors
Address [1] 298836 0
Physiotherapy Department
Calvary Health Care Bethlehem
476 Kooyong Road
Caulfield South 3162
Country [1] 298836 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300432 0
Calvary Health Care Bethlehem Research Ethics & Ethics Committee
Ethics committee address [1] 300432 0
Ethics committee country [1] 300432 0
Australia
Date submitted for ethics approval [1] 300432 0
Approval date [1] 300432 0
26/04/2018
Ethics approval number [1] 300432 0
18021201

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

Contacts
Principal investigator
Name 83646 0
Ms Trinh Nguyen
Address 83646 0
Calvary Health Care Bethlehem
476 Kooyong Road
Caulfield South 3162
Country 83646 0
Australia
Phone 83646 0
+61 03 9595 3494
Fax 83646 0
Email 83646 0
[email protected]
Contact person for public queries
Name 83647 0
Trinh Nguyen
Address 83647 0
Calvary Health Care Bethlehem
476 Kooyong Road
Caulfield South 3162
Country 83647 0
Australia
Phone 83647 0
+61 03 9595 3494
Fax 83647 0
Email 83647 0
[email protected]
Contact person for scientific queries
Name 83648 0
Trinh Nguyen
Address 83648 0
Calvary Health Care Bethlehem
476 Kooyong Road
Caulfield South 3162
Country 83648 0
Australia
Phone 83648 0
+61 03 9595 3494
Fax 83648 0
Email 83648 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.