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Trial registered on ANZCTR


Registration number
ACTRN12612000224820
Ethics application status
Approved
Date submitted
17/02/2012
Date registered
22/02/2012
Date last updated
17/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilates: fitness fad or next frontier in falls prevention and bone health? A pilot randomised controlled trial.
Scientific title
A pilot randomised controlled study of older community dwelling individuals at risk of suffering a fall injury, that will determine the impact of physiotherapist delivered Pilates exericse on falls and falls injury risk.
Secondary ID [1] 279961 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental falls 285878 0
Osteopenia 285879 0
Osteoporosis 285880 0
Condition category
Condition code
Physical Medicine / Rehabilitation 286065 286065 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 286066 286066 0 0
Other injuries and accidents
Musculoskeletal 286067 286067 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:
The intervention group will receive the Physiotherapist delivered Pilates exercise program. This includes a 60 minute program twice weekly for 12 weeks as well as a 20 minute tailored daily home exercise program.

Arm 2:
The intervention group will receive the Physiotherapist delivered Pilates exercise program. This includes a 60 minute program twice weekly for 24 weeks as well as a 20 minute tailored daily home exercise program.

The physiotherapist delivered Pilates exercise for both intervention arms will include progressive balance and lower limb strength exercises that utilise Pilates equipment such as a Reformer, Trapeze Table, Wunda Chair and Swiss ball. All exercises will include 5 minutes of warm-up exercises at the start of the session and a 5 minute cool-down at the end of the session. Balance exercises will include standing with a decreased base of support (for example in single leg stance); reaching and extending the limbs forwards and sideways whilst keeping the trunks stable; controlled movements of the body; minimal use of hands for support; sensory challenges with eyes closed, head turns, unstable surfaces; and dual tasking (ball throwing). Lower limb strength exercises will be performed predominantly in standing positions and will involve moving the leg against resistance of the springs in the Pilates equipment. For example, standing and stepping down on the peddle of the Wunda Chair.

Participants in both intervention arms will receive standardised falls prevention and bone health advice in the form of a booklet from Osteoporosis Australia "Exercise and Fracture Prevention: A Guide for Consumers".

Participants in both intervention arms will be provided information surrounding their balance, falls risk and lower limb strength following the completion of the baseline, 12-week and 24-week physical assessments. Their performance will be compared to age normal values and the areas requiring focus to reduce falls risk will be identified. All participants will be encouraged to discuss these results with the Medical practitioner and any other health professionals involved with their care.

The Medical practitioners of participants in both intervention arm's will receive a copy of the 'Falls facts for doctors' that details best practice recommendations and a summary of their patients physical assessment results at baseline, 12 weeks and 24 weeks.

Medical practitioners of participants in Arm 2 will receive a copy of the 24 week DXA results.
Intervention code [1] 284294 0
Prevention
Intervention code [2] 284295 0
Treatment: Other
Intervention code [3] 284296 0
Rehabilitation
Comparator / control treatment
Arm 3 and 4:
The control groups will continue to receive their usual care from their Medical Practitioner and other health care practitioners that they choose to access.

Participants in both control arms will receive standardised falls prevention and bone health advice in the form of a booklet from Osteoporosis Australia "Exercise and Fracture Prevention: A Guide for Consumers".

Participants in both control arms will be provided with information surrounding their balance, falls risk and lower limb strength following the completion of the baseline, 12 week and 24 week physical assessments. Their performance will be compared to age normal values and the areas requiring focus to reduce falls risk will be identified. All participants will be encouraged to discuss these results with their Medical practitioner and any other health professionals involved with their care.

Medical practitioners for both control arm participants will receive a copy of the 'Falls facts for doctors' that details best practice recommendations and a summary of the participant's physical assessment results.

Only Arm 4 participant's will undergo a DXA scan at 24 weeks. A copy of the results of these DXA scans will be provided to Arm 4 participants Medical practitioners.

Following the 24 week assessment participants in both arms will be offered a Pilates exercise class free of charge as an incentive to participate in the study.
Control group
Active

Outcomes
Primary outcome [1] 286546 0
Arm 1, 2, 3 and 4:
Number of falls assessed by the rate of falls (per-person-per-year). Falls will be recorded on the participants falls diary and verified by the monthly telephone follow-up.
Timepoint [1] 286546 0
At baseline, and 12 and 24 weeks after intervention commencement
Primary outcome [2] 286547 0
Arm 1, 2, 3 and 4:
Change to standing balance as measured by seven physical performance tests proven to be valid and reliable measures of balance: 1. The Step Test 2. Functional Reach test 3. Timed Up & Go 4. Lateral Reach test 5. Clinical test of Sensory Interaction on Balance 6. Dynamic Gait Index 7. Four Square Step test
Timepoint [2] 286547 0
At baseline, and 12 and 24 weeks after intervention commencement
Primary outcome [3] 286548 0
Arm 2 and 4:
Change in lumbar spine (L2-L4) and femoral neck bone mineral density as assessed via Dual-emission X-ray absorptiometry (DXA).
Timepoint [3] 286548 0
At baseline and at 24-28 weeks after the baseline assessment after the intervention commencement.
Secondary outcome [1] 296133 0
Arm 1, 2, 3 and 4:
Lower limb strength as assessed using the Timed Sit-to-Stand test.
Timepoint [1] 296133 0
At baseline and at 12 and 24 weeks after intervention commencement.
Secondary outcome [2] 296134 0
Arm 1, 2, 3 and 4:
Flexibility of lower limb as measured using the straight leg raise and knee-to-wall
Timepoint [2] 296134 0
At baseline and at 12 and 24 weeks after intervention commencement.
Secondary outcome [3] 296135 0
Arm 1, 2, 3 and 4:
Physical characteristics of age, weight, height and calculated body mass index.
Timepoint [3] 296135 0
At baseline and at 12 and 24 weeks after intervention commencement.
Secondary outcome [4] 296136 0
Arm 1, 2, 3 and 4:
Quality of life assessed using the EQ-5D.
Timepoint [4] 296136 0
At baseline and at 24 weeks after intervention commencement.
Secondary outcome [5] 296137 0
Arm 1, 2, 3 and 4:
Activity level as assessed using the Human Activity Profile.
Timepoint [5] 296137 0
At baseline and at 24 weeks after intervention commencement.
Secondary outcome [6] 296138 0
Arm 1, 2, 3 and 4:
Falls efficacy as assessed using the short version of the Activities-specific Balance Confidence (ABC-6) scale.
Timepoint [6] 296138 0
At 12 and 24 weeks after intervention commencement.
Secondary outcome [7] 296139 0
Arm 1 and 2: Compliance as measured by recording the number of Pilates sessions attended and amount of home exercises completed.
Timepoint [7] 296139 0
At baseline and at 24 weeks after intervention commencement.
Secondary outcome [8] 298148 0
Arm 1 and 2:
Satisfaction as measured using a 5-point Likert scale Satisfaction survey.
Timepoint [8] 298148 0
at 24 weeks after intervention commencement.

Eligibility
Key inclusion criteria
Arms 1, 2, 3 and 4:
Community-dwelling men and women (i) identified as being at high risk of suffering a fall related injury on screening assessment; (ii) aged 60 years or over; and (iii) able to negotiate a set of 10 stairs independently without a gait aid. Medical clearance will be required from each participant's Medical practitioner to certify him/her as able to participate in moderate intensity physiotherapist supervised exercise before being accepted into the trial.

And:

Arm 2 and 4:
Community-dwelling men and women that have low bone mineral density (t-score > 1SD below age related normal score) as diagnosed from a DXA scan within the last 6 months at a selected imaging centre.
Minimum age
60 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Arm 1, 2, 3 and 4:
Participants will be excluded if they: (i) have a telephone Mini-Mental State Examination score of <17; (ii) are already attending Pilates or other formal exercise class (60 minutes or more per week) for 4 or more weeks in the previous 12 weeks; (iii) currently or recently have or have had an acute medical condition; (iv) have had cancer within the past 5 years and/or currently undergoing active treatment for cancer or (v) suffering from uncontrolled chronic conditions that would interfere with the safety and conduct of the assessments or Pilates exercise intervention.

Arm 2 and 4: As stated above with the additional exclusion criteria of: (i) have received hormone therapy in the last 2 years; or (ii) have commenced taking medication(s) known to affect bone metabolism in the previous 90 days

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)
Enrolment: The study will be advertised via posters and flyers in 1. Physiotherapy and Pilates studio's, including the Physiotherapy practice where the intervention will be delivered; 2. Local GP practice; 3. The Medical Imaging centre where the DXA scans will be performed; 4. Monash University e-News. The posters and flyers will prompt people to contact the research team for further information. Potential participants will then undergo a telephone screening for eligibility. If deemed eligible for inclusion in the study participants will be invitied to attend a baseline assessment at which time written informed consent will be obtained. Following recruitment all participants will undergo a baseline assessment. The baseline assessment will be prior to randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. A Monash University statistician will obtain a computer generated random number sequence to detemine group allocation. Each group allocation in the sequence will then be placed in a numbered opaque envelope. The allocation contained within each envelope will then be checked by a second person agaist the randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5015 0
3004

Funding & Sponsors
Funding source category [1] 284730 0
University
Name [1] 284730 0
Faculty of Medicine, Nursing and Health Sciences Strategic Grant Scheme Monash University
Country [1] 284730 0
Australia
Primary sponsor type
University
Name
Faculty of Medicine, Nursing and Health Sciences Strategic Grant Scheme Monash University
Address
Faculty of Medicine, Nursing and Health Sciences
Monash University,
Wellington Road Clayton
Victoria 3800
Country
Australia
Secondary sponsor category [1] 283627 0
None
Name [1] 283627 0
Address [1] 283627 0
Country [1] 283627 0
Other collaborator category [1] 260550 0
Commercial sector/Industry
Name [1] 260550 0
Dynamic Stability
Address [1] 260550 0
Level 1, 161-165 Swan Street
Richmond
Victoria 3121
Country [1] 260550 0
Australia
Other collaborator category [2] 260551 0
Other
Name [2] 260551 0
Richmond Hill Medical Centre
Address [2] 260551 0
2 Royal Place
Richmond
Victoria 3121
Country [2] 260551 0
Australia
Other collaborator category [3] 260552 0
Commercial sector/Industry
Name [3] 260552 0
Healthcare Diagnostic Imaging
Address [3] 260552 0
Epworth Hospital
Level 2, 89 Bridge Road
Richmond
Victoria 3121
Country [3] 260552 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286738 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 286738 0
Ethics committee country [1] 286738 0
Australia
Date submitted for ethics approval [1] 286738 0
Approval date [1] 286738 0
Ethics approval number [1] 286738 0
CF12/0364 - 2012000165

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

Contacts
Principal investigator
Name 33793 0
Address 33793 0
Country 33793 0
Phone 33793 0
Fax 33793 0
Email 33793 0
Contact person for public queries
Name 17040 0
Dr Anna Barker
Address 17040 0
Senior Research Fellow
Centre of Research Excellence in Patient Safety
School of Public Health and Preventive Medicine

Faculty of Medicine, Nursing and Health Sciences
Monash University, The Alfred Centre
Level 6, 99 Commerical Road
Melbourne Victoria 3004
Country 17040 0
Australia
Phone 17040 0
+61 3 9903 0946
Fax 17040 0
+61 3 9903 0556
Email 17040 0
anna.barker@monash.edu
Contact person for scientific queries
Name 7968 0
Dr Anna Barker
Address 7968 0
Senior Research Fellow
Centre of Research Excellence in Patient Safety
School of Public Health and Preventive Medicine

Faculty of Medicine, Nursing and Health Sciences
Monash University, The Alfred Centre
Level 6, 99 Commerical Road
Melbourne Victoria 3004
Country 7968 0
Australia
Phone 7968 0
+61 3 9903 0946
Fax 7968 0
+61 3 9903 0556
Email 7968 0
anna.barker@monash.edu

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.