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Trial registered on ANZCTR


Registration number
ACTRN12617000737336
Ethics application status
Approved
Date submitted
16/05/2017
Date registered
19/05/2017
Date last updated
19/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Group exercise for people with chronic physical impairment.
Scientific title
A randomised, cross-over control trial to assess the efficacy of group exercise to maintain or improve physical function in people with chronic physical impairment.
Secondary ID [1] 291968 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 303313 0
Stroke 303314 0
Falls 303315 0
Chronic physical impairment 303341 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302755 302755 0 0
Physiotherapy
Neurological 302770 302770 0 0
Parkinson's disease
Stroke 302771 302771 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At time of enrolment, all participants will have already been attending exercise groups, and will have been given an individualised home exercise programme.
During the 20-week intervention period, participants will continue to attend the exercise groups that they were attending at time of enrolment in the study. They will also be given the option to attend a second exercise group per week for this period.
Exercise duration is 45 minutes, at the hospital.
Groups are run by an experienced Physiotherapist, with up to 15 participants per group.
Groups are stratified to participant ability, and, to some extent, health condition.
All groups offer functional strength training, and balance training, and participants are encouraged to work at an effort of 6-8/10 for the duration of the class.
Choice of exercises is tailored to the ability and needs of the group members.
Parkinson's Disease- specific groups focus on exaggerated amplitude movements.
Attendance is recorded at each group.
Patients are also encouraged to exercise at home, at least 3 times per week in addition to the exercise group(s).
Intervention code [1] 298095 0
Rehabilitation
Comparator / control treatment
Cross-over control. In the control phase, participants are to cease group attendance for 20 weeks, but are encouraged to continue with their home exercise programme.
Control group
Active

Outcomes
Primary outcome [1] 302143 0
Falls, self-reported in falls diary
Timepoint [1] 302143 0
After 20 weeks of attending groups, and after 20 weeks of not attending groups
Secondary outcome [1] 334950 0
QOL-6D
Timepoint [1] 334950 0
After 20 weeks of attending groups, and after 20 weeks of not attending groups
Secondary outcome [2] 334951 0
10 metre walk test
Timepoint [2] 334951 0
After 20 weeks of attending groups, and after 20 weeks of not attending groups
Secondary outcome [3] 334952 0
6-minute walk test
Timepoint [3] 334952 0
After 20 weeks of attending groups, and after 20 weeks of not attending groups
Secondary outcome [4] 334953 0
Berg Balance Score
Timepoint [4] 334953 0
After 20 weeks of attending groups, and after 20 weeks of not attending groups
Secondary outcome [5] 334954 0
Timed get-up-and-go test
Timepoint [5] 334954 0
After 20 weeks of attending groups, and after 20 weeks of not attending groups
Secondary outcome [6] 334955 0
Five-times sit-to-stand test
Timepoint [6] 334955 0
After 20 weeks of attending groups, and after 20 weeks of not attending groups

Eligibility
Key inclusion criteria
People with ongoing physical impairment affecting their mobility, due to neurological illness or otherwise.
Able and willing to attend hospital weekly.
Already attending weekly exercise groups at time of initiation of trial.
Capable and safe to exercise in a group setting- GP clearance required.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medically unsuitable for semi-supervised exercise- including uncontrolled hypertension, diabetes with poor glucose control, unstable angina, uncontrolled cardiac failure, symptomatic hypotension, severe aortic stenosis, acute infection or fever, resting tachycardia or arrhythmia.
Inability to give written informed consent.
Inability to exercise independently or with a carer who attends with them.

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)
Central randomisation after all participants are enrolled.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An intention-to-treat analysis of each outcome variable will be performed using within-subject differences for those allocated to sequence AB compared with those allocated to sequence BA.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/06/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8025 0
St Joseph's Hospital - Auburn
Recruitment postcode(s) [1] 16011 0
2144 - Auburn

Funding & Sponsors
Funding source category [1] 296478 0
Hospital
Name [1] 296478 0
St Joseph's Hospital
Country [1] 296478 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
390 Victoria St Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 295436 0
None
Name [1] 295436 0
Address [1] 295436 0
Country [1] 295436 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297700 0
St Vincent's Hospital HREC
Ethics committee address [1] 297700 0
Ethics committee country [1] 297700 0
Australia
Date submitted for ethics approval [1] 297700 0
01/12/2016
Approval date [1] 297700 0
16/05/2017
Ethics approval number [1] 297700 0
16/236

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

Contacts
Principal investigator
Name 74874 0
Mrs Johannah Campbell
Address 74874 0
Physiotherapy Department
St Joseph's Hospital
2A Normanby Road
Auburn NSW 2144
Country 74874 0
Australia
Phone 74874 0
+61,2,97490385
Fax 74874 0
Email 74874 0
johannah.campbell@svha.org.au
Contact person for public queries
Name 74875 0
Johannah Campbell
Address 74875 0
Physiotherapy Department
St Joseph's Hospital
2A Normanby Rd
Auburn NSW 2144
Country 74875 0
Australia
Phone 74875 0
+61,2,97490385
Fax 74875 0
Email 74875 0
johannah.campbell@svha.org.au
Contact person for scientific queries
Name 74876 0
Johannah Campbell
Address 74876 0
Physiotherapy Department
St Joseph's Hospital
2A Normanby Rd
Auburn NSW 2144
Country 74876 0
Australia
Phone 74876 0
+61,2,97490385
Fax 74876 0
Email 74876 0
johannah.campbell@svha.org.au

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.