Trial Review

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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
Sex
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
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
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
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
[email protected]
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
[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.