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Trial registered on ANZCTR


Registration number
ACTRN12610000909022
Ethics application status
Approved
Date submitted
25/10/2010
Date registered
26/10/2010
Date last updated
15/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Minimising functional decline amongst older adults with a novel intervention against a traditional intervention.
Scientific title
Minimising functional decline in the frail older adult with a Nintendo WiiActive exercise programme against a gym-based exercise programme.
Secondary ID [1] 252949 0
Singhealth services foundation research grant SHF/FG397S/2009
Universal Trial Number (UTN)
U1111-1117-5893
Trial acronym
Frail older adult managements (FOAM)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gait speed 258480 0
Quality of life 258481 0
Endurance 258482 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258647 258647 0 0
Physiotherapy
Musculoskeletal 258648 258648 0 0
Osteoarthritis
Musculoskeletal 258649 258649 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Wii Active exercise programme 1x/week and approximately an hour (rest time inclusive), sessions are in small groups supervised by a physiotherapist over a period of 12 weeks.

Concurrently, home exercise 2x/week on non-programme days. Each session between 0.5-1 hour.

Wii intervention 15-20 minutes, stretching 5 minutes, balance training 10 minutes, resistance training 10 minutes, 10 minutes variable training based on subject needs including pain management.

Home programme: Stretching, balance and agility training, strength training and cardiovascular training.
Intervention code [1] 257479 0
Rehabilitation
Intervention code [2] 257480 0
Lifestyle
Comparator / control treatment
Traditional exercise programme involving aerobic, balance and strength training 1x/week and approximately an hour (rest time inclusive), sessions are in small groups supervised by a physiotherapist over a period of 12 weeks.

Concurrently, home exercise 2x/week on non-programme days. Each session between 0.5-1 hour.

Cardiovascular training 15-20 minutes, stretching 5 minutes, balance training 10 minutes, strength training 10 minutes, 10 minutes variable training based on subject needs including pain management.

Home programme: Stretching, balance and agility training, strength training and cardiovascular training.
Control group
Active

Outcomes
Primary outcome [1] 259493 0
Gait speed (m/s) from short physical performance battery (SPPB) 4m walk test. Normative value is 0.8m/s because acceleration was not factored into the test.
Timepoint [1] 259493 0
Baseline and 13th week
Primary outcome [2] 259495 0
6 minutes walk test for endurance assessment
Timepoint [2] 259495 0
Baseline, 13th week
Secondary outcome [1] 266084 0
Short Falls Efficacy - International (Short FES-I)
Timepoint [1] 266084 0
Baseline, 13th week
Secondary outcome [2] 266085 0
Quality of Life SF-36
Timepoint [2] 266085 0
Baseline, 13th week
Secondary outcome [3] 266086 0
Short Physical Performance Battery (SPPB)
Timepoint [3] 266086 0
Baseline, 13th week

Eligibility
Key inclusion criteria
Community dwelling
Poor fall efficacy
Moderately frail (short physical performance battery score 5-9)
Ambulatory independent (assistive devices accepted: walking stick and quad-stick)
Minimum age
60 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Permanent bed-bound
Disabled in ambulation / requires a walking frame or rollator frame for ambulation
Significant cognitive disorder
Untreated aortic stenosis or ischemia
Unrepaired aortic, cerebral or abdominal aneurysm
End-stage illness or disease
Life expectancy less than a year
Cerebral haemorrhage within the past 3 months
Fractures in healing phase
Surgery within the past 6 months
Pulmonary embolism or deep vein thrombosis (DVT) within 3 months
Uncontrolled medical condition(s)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation concealed in sealed envelopes by an independent co-investigator not involved as an assessor nor treater.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2993 0
Singapore
State/province [1] 2993 0

Funding & Sponsors
Funding source category [1] 257929 0
Charities/Societies/Foundations
Name [1] 257929 0
Singhealth Foundation
Address [1] 257929 0
Singapore General Hospital Outram Road S(169608)
Country [1] 257929 0
Singapore
Primary sponsor type
Charities/Societies/Foundations
Name
Singhealth Foundation
Address
Singapore General Hospital Outram Road S(169608)
Country
Singapore
Secondary sponsor category [1] 257120 0
None
Name [1] 257120 0
None
Address [1] 257120 0
None
Country [1] 257120 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The primary aim of this study is to introduce a new intervention into a healthcare system.
Primary hypothesis is that the novel intervention is as effective as the traditional group therapy in preventing functional decline.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31829 0
Address 31829 0
Country 31829 0
Phone 31829 0
Fax 31829 0
Email 31829 0
Contact person for public queries
Name 15076 0
Kwok Boon Chong
Address 15076 0
Block 3 Level 1 Rehabilitation Centre Physiotherapy Singapore General Hospital Outram Road S(169608)
Country 15076 0
Singapore
Phone 15076 0
+65 2 97828332
Fax 15076 0
Email 15076 0
kwok.boon.chong@sgh.com.sg
Contact person for scientific queries
Name 6004 0
Kwok Boon Chong
Address 6004 0
Block 3 Level 1 Rehabilitation Centre Physiotherapy Singapore General Hospital Outram Road S(169608)
Country 6004 0
Singapore
Phone 6004 0
+65 2 97828332
Fax 6004 0
Email 6004 0
kwok.boon.chong@sgh.com.sg

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary