Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000350729
Ethics application status
Approved
Date submitted
25/03/2013
Date registered
2/04/2013
Date last updated
24/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a personalised home exercise DVD program on exercise adherence in patients who have fractured their hip
Scientific title
The effects of a personalised home exercise DVD program on exercise adherence in patients who have fractured their hip 12-24 months ago: A feasibility study
Secondary ID [1] 282182 0
nil
Universal Trial Number (UTN)
U1111-1141-0313
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
accidental falls 288695 0
hip fracture 288696 0
Condition category
Condition code
Injuries and Accidents 289045 289045 0 0
Fractures
Physical Medicine / Rehabilitation 289058 289058 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be initially assessed then prescribed a personalised home exercise program. The participant will receive a DVD of the exercises performed by the patient themself, including the Physiotherapist corrections and advice. They will be asked to do their exercises 3 times per week for approximately 30 minutes. Initial consultation of approximately 1 hour followed by 30 minute appointments weekly for 6 weeks. At reappointments, review and motivational interviewing will occur. DVD will not be updated but repetitions and feedback will be reviewed again so that partiicpants increase intensity as judged able by the therapist. Lower limb strength and balance exercises tailored for each participant. participants watch DVD each time they complete exercises. Phone call and exercise diary as well as semi structured interview to measure adherence and response to program. At 6 weeks participants will be asked to continue with their final prescribed programme till the 6 month review.
Intervention code [1] 286789 0
Treatment: Other
Intervention code [2] 286790 0
Behaviour
Intervention code [3] 286803 0
Rehabilitation
Comparator / control treatment
No control group before and after study each participant acts as their own control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289155 0
Participation in activities measure CHAMPS questionnaires
Timepoint [1] 289155 0
At baseline and 6 weeks post intervention and 6 months after the intervention
Primary outcome [2] 289156 0
Reported exercise adherence with exercise diary and semi structured interviews.
Timepoint [2] 289156 0
At baseline and 6 weeks after intervention, and 6months after the intervention
Primary outcome [3] 289172 0
Self efficacy exercise measure SEE
Timepoint [3] 289172 0
Baseline, 6 weeks and 6 months after the intervention
Secondary outcome [1] 301943 0
Functional mobility measures: Timed up and go test, 10 metre self paced walk test
Timepoint [1] 301943 0
At baseline and 6 weeks after intervention

Eligibility
Key inclusion criteria
60-85 years, Hip fracture 12-24 months ago, medically stable, English speaking, Cognitively intact, able to give informed consent
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment, Sensory deficit that prevents patient hearing instructions or viewing a DVD on their TV at home, assessed by checking with patient that they can hear instructions and view DVDs at home, Parkinson’s Disease, previous history of stroke

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)
Swan Districts Hospital (SDH) physiotherapy and nursing staff will be given flyers notifying them of the study outline as well as participant inclusion and exclusion criteria. The SDH Geriatrician will be included in the participant recruitment process as well as participant screening. The majority of the participants are expected to come from recent falls/deconditioned patients via geriatrician referral. Participant flyers will also be placed in the SDH outpatient department for prospective participants to see, expression of interested are then referred to physiotherapist.



Eligible patients will be given the study information verbally by the researcher, and in writing via the information and consent forms. Patients will be encouraged to discuss their proposed participation with family or carers. Patients who subsequently provide informed written consent will be enrolled into the six month study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculated based on determining the feasiblity of being able to provide the intervention. This involves determining how much time the intervention will take to deliver including making the DVD. It has been determined that we will need to assess a minimum of 5 patients to become expert in making the DVD with a real patient. This is based on our trials with normal subjects. This trial is not testing a hypothesis but if the intervention is feasible and older people respond positively we can then progress to a larger pilot study, which does test hypotheses. This trial will examine the feasibility and inform the design, in particular the novel DVD intervention to provide exercise prescription, as well as sample size calculations for future larger randomised controlled trials. We will collect data on aspects of the trial procedure, including number of subjects who consent to participate from the potential cohort of subjects, and the number of drop outs from the study, amount of time required to make the DVD, quality of the finished product and ability of the exercises to be filmed “live” in an outpatient department

Quantitative data will be analysed using descriptive statistics. Qualitative data will be transcribed, coded and thematically analysed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2013
Actual
23/04/2013
Date of last participant enrolment
Anticipated
15/06/2013
Actual
7/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
7
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 795 0
Swan Districts Hospital - Middle Swan
Recruitment postcode(s) [1] 6612 0
6055 - South Guildford
Recruitment postcode(s) [2] 6613 0
6056 - Midland
Recruitment postcode(s) [3] 6614 0
6084 - Bullsbrook
Recruitment postcode(s) [4] 6615 0
6076 - Kalamunda

Funding & Sponsors
Funding source category [1] 286950 0
Self funded/Unfunded
Name [1] 286950 0
nil
Country [1] 286950 0
Primary sponsor type
Individual
Name
Dr Anne-Marie Hill
Address
The University of Notre Dame Australia

School of Physiotherapy, Fremantle Campus
19 Mouat St (Box 1225)
Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 285736 0
None
Name [1] 285736 0
Address [1] 285736 0
Country [1] 285736 0
Other collaborator category [1] 277331 0
Individual
Name [1] 277331 0
Associate Professor Shane Patman
Address [1] 277331 0
The University of Notre Dame Australia

School of Physiotherapy, Fremantle Campus
19 Mouat St (Box 1225)
Fremantle WA 6959
Country [1] 277331 0
Australia
Other collaborator category [2] 277332 0
Individual
Name [2] 277332 0
Mrs Jacqueline Francis-Coad
Address [2] 277332 0
The University of Notre Dame Australia
,
School of Physiotherapy, Fremantle Campus
19 Mouat St (Box 1225)
Fremantle WA 6959
Country [2] 277332 0
Australia
Other collaborator category [3] 277333 0
Individual
Name [3] 277333 0
Mr Luke Moran
Address [3] 277333 0
The University of Notre Dame Australia

School of Physiotherapy, Fremantle Campus
19 Mouat St (Box 1225)
Fremantle WA 6959
Country [3] 277333 0
Australia
Other collaborator category [4] 277334 0
Individual
Name [4] 277334 0
Mr Warren Watts
Address [4] 277334 0
Senior Musculoskeletal Physiotherapist
Physiotherapy Department
Swan Kalamunda Health Service
Eveline Rd
MIdland WA 6056
Country [4] 277334 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289002 0
The University of Notre DAme Australia HREC
Ethics committee address [1] 289002 0
Ethics committee country [1] 289002 0
Australia
Date submitted for ethics approval [1] 289002 0
Approval date [1] 289002 0
07/01/2013
Ethics approval number [1] 289002 0
012112F
Ethics committee name [2] 289003 0
Sir Charles Gairdner Group HREC
Ethics committee address [2] 289003 0
Ethics committee country [2] 289003 0
Australia
Date submitted for ethics approval [2] 289003 0
Approval date [2] 289003 0
21/02/2013
Ethics approval number [2] 289003 0
2012-190

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

Contacts
Principal investigator
Name 38746 0
Dr Anne-Marie Hill
Address 38746 0
The University of Notre Dame Australia
,
School of Physiotherapy, Fremantle Campus
19 Mouat St (Box 1225)
Fremantle WA 6959
Country 38746 0
Australia
Phone 38746 0
+61 8 94330239
Fax 38746 0
+61 8 94330210
Email 38746 0
[email protected]
Contact person for public queries
Name 38747 0
Anne-Marie Hill
Address 38747 0
The University of Notre Dame Australia
,
School of Physiotherapy, Fremantle Campus
19 Mouat St (Box 1225)
Fremantle WA 6959
Country 38747 0
Australia
Phone 38747 0
61 8 9433 0239
Fax 38747 0
+61 8 94330210
Email 38747 0
[email protected]
Contact person for scientific queries
Name 38748 0
Anne-Marie Hill
Address 38748 0
The University of Notre Dame Australia
,
School of Physiotherapy, Fremantle Campus
19 Mouat St (Box 1225)
Fremantle WA 6959
Country 38748 0
Australia
Phone 38748 0
61 8 9433 0239
Fax 38748 0
+61 8 94330210
Email 38748 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.