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
ACTRN12616000946415
Ethics application status
Approved
Date submitted
14/07/2016
Date registered
18/07/2016
Date last updated
28/11/2018
Date data sharing statement initially provided
28/11/2018
Date results provided
28/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Personalised DVD home exercise programs to improve the physical and mental health of older patients after functional decline
Scientific title
Evaluating the effect of providing a home-based tailored DVD exercise program in addition to usual care on physical and mental status of older patients after functional decline : A pre-post trial
Secondary ID [1] 289630 0
nil known
Universal Trial Number (UTN)
U1111-1185-1642
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fracture 299417 0
fall 299418 0
functional decline 299419 0
Condition category
Condition code
Injuries and Accidents 299396 299396 0 0
Fractures
Musculoskeletal 299397 299397 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 299398 299398 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Personalised exercise program prescribed by physiotherapist. The exercises are placed on a DVD for the patient to complete as a home program with the patient choosing the frequency of completing the program. Exercise to be performed for 7 weeks. All exercises personalised for participant by physiotherapist after one hour consultation. Participant performs same exercise routine for 7 weeks - participant chooses duration and number of repetitions to perform. Exercises are videoed in the clinic and a DVD is given to participants to use at home to complete the exercise. Participants keep a diary to record their exercise adherence.
Intervention code [1] 295244 0
Treatment: Other
Intervention code [2] 295245 0
Behaviour
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298869 0
Functional mobility measured with timed up and go and ten meter walk test
Timepoint [1] 298869 0
7 weeks after exercise program prescribed
Primary outcome [2] 298870 0
Health related quality of life measured with Eq-5D
Timepoint [2] 298870 0
7 weeks after exercise
Primary outcome [3] 298871 0
Levels of physical activitity using CHAMPS questionnaire
Timepoint [3] 298871 0
7 weeks after exercise program prescribed
Secondary outcome [1] 325495 0
5. Participants confidence and motivation (composite secondary outcome) to engage in exercise program using SEE scale for exercise
Timepoint [1] 325495 0
7 weeks after exercise program prescribed

Eligibility
Key inclusion criteria
60 years or younger than 86 years, approximately 3 months post-operatively following a hip fracture or other fracture or medical condition resulting in functional decline, medically stable, English speaking, cognitively intact and able to give informed consent
Minimum age
60 Years
Maximum age
86 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parkinson’s Disease (PD), previous history of stroke. cognitive impairment or diagnosis of dementia

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not required for pre-post study all participants allocated to intervention
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Differences in continuous outcome measures will be compared (pre and post intervention) using dependent t tests, or their non-parametric alternative. CHAMPS MET groups will be compared pre and post using Chi-square analysis.
We will also examine the effect size to calculate a sample size for future larger randomised trials.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/07/2016
Actual
1/09/2016
Date of last participant enrolment
Anticipated
28/02/2017
Actual
30/10/2017
Date of last data collection
Anticipated
Actual
30/12/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6129 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 13571 0
6160 - Fremantle
Recruitment postcode(s) [2] 13572 0
6162 - South Fremantle
Recruitment postcode(s) [3] 13573 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 294064 0
Charities/Societies/Foundations
Name [1] 294064 0
Fremantle Hospital Medical Research Foundation
Country [1] 294064 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Anne-Marie Hill
Address
The University of Notre Dame Australia
Institute for Health Research
32 Mouat Street, Fremantle, WA 6959
PO Box 1225, Fremantle, WA 6959

Curtin University
School of Physiotherapy and Exercise Science
Kent Street Bentley WA 6102
GPO Box U1987 Perth WA 6845
Country
Australia
Secondary sponsor category [1] 292892 0
University
Name [1] 292892 0
The University of Notre Dame Australia
Address [1] 292892 0
32 Mouat Street, Fremantle, WA 6959
PO Box 1225, Fremantle, WA 6959
Country [1] 292892 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295476 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 295476 0
Ethics committee country [1] 295476 0
Australia
Date submitted for ethics approval [1] 295476 0
Approval date [1] 295476 0
Ethics approval number [1] 295476 0
Ethics committee name [2] 295477 0
The University of Notre Dame Australia HREC
Ethics committee address [2] 295477 0
Ethics committee country [2] 295477 0
Australia
Date submitted for ethics approval [2] 295477 0
27/10/2015
Approval date [2] 295477 0
17/12/2015
Ethics approval number [2] 295477 0
015146F

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

Contacts
Principal investigator
Name 67250 0
A/Prof Anne-Marie Hill
Address 67250 0
The University of Notre Dame Australia
Institute for Health Research
32 Mouat Street, Fremantle, WA 6959
PO Box 1225, Fremantle, WA 6959


Curtin University
School of Physiotherapy and Exercise Science
Kent Street Bentley WA 6102
GPO Box U1987 Perth WA 6845
Country 67250 0
Australia
Phone 67250 0
+61892664104
Fax 67250 0
Email 67250 0
[email protected]
Contact person for public queries
Name 67251 0
Anne-Marie Hill
Address 67251 0
Curtin University
School of Physiotherapy and Exercise Science
Kent Street Bentley WA 6102
GPO Box U1987 Perth WA 6845
Country 67251 0
Australia
Phone 67251 0
+61892664104
Fax 67251 0
Email 67251 0
[email protected]
Contact person for scientific queries
Name 67252 0
Anne-Marie Hill
Address 67252 0
Curtin University
School of Physiotherapy and Exercise Science
Kent Street Bentley WA 6102
GPO Box U1987 Perth WA 6845
Country 67252 0
Australia
Phone 67252 0
+61892664104
Fax 67252 0
Email 67252 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not planned for in in original trial


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.