Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001013055
Ethics application status
Approved
Date submitted
5/01/2010
Date registered
18/11/2010
Date last updated
10/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of progressive resistance training on falls, balance and quality of life in older adults with impaired balance.
Scientific title
Progressive Resistance Training for falls, balance and quality of life in older adults with impaired balance: A randomised controlled trial.
Secondary ID [1] 1273 0
nil
Universal Trial Number (UTN)
U1111-1113-1317
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired Balance
Falls
Ageing 256471 0
Condition category
Condition code
Musculoskeletal 256638 256638 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Progressive Resistance Training
- Twice a week for 12 weeks
- Each session 45 mins - 1 hour duration
- Aerobic warm up and cool down involving either treadmill or bike for 3-5 minutes at the beginning and end of each session.
- The intensity will be set between 70-80% of 1-Repetition Maximum (1-RM), two sets of 10-15 repetitions.
- 8-10 lower limbs exercises
- The exercise will be administered by an Exercise Physiologist; initially 1:1, and then in small groups with close supervision.
Intervention code [1] 255755 0
Rehabilitation
Comparator / control treatment
Wait list control.
The control group will be offered the exercise intervention after the 12 week study period.
Control group
Active

Outcomes
Primary outcome [1] 257530 0
Balance - Berg Balance Scale (BBS)
Timepoint [1] 257530 0
Baseline and post intervention (12 weeks)
Secondary outcome [1] 262760 0
Incidence of Falls, measured via patient diary
Timepoint [1] 262760 0
Baseline and post intervention (12 weeks)
Secondary outcome [2] 262761 0
Quality of Life - Assessment of Quality of Life (AQoL)
Timepoint [2] 262761 0
Baseline and post intervention (12 weeks)
Secondary outcome [3] 262762 0
Strength - One-Repetition Assessment of Lower limb strength. Knee flexion, Knee Extension, Leg Press, Hip Abduction, Hip Extension
Timepoint [3] 262762 0
Baseline and post intervention (12 weeks)

Eligibility
Key inclusion criteria
Inclusion critera:
- Referral to Centre for Physical Activity in Ageing (CPAA)
- 65 yrs of age or older
- Berg Balance Scale (BBS) score of <45/56; and/or one or more falls in the last 12 months; or reason for referral to improve balance.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
- Current participation in a supervised strength training program.
- Contraindications to high-intensity resistance training e.g. rheumatoid arthritis, fibromyalgia, neurological conditions etc.
- History of dementia or cognitive impairment.

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)
Sealed opaque envelopes
Central randmisation by phone by external party
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256241 0
Hospital
Name [1] 256241 0
Royal Adelaide Hospital
Country [1] 256241 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 251571 0
Hospital
Name [1] 251571 0
Centre for Physical Activity in Ageing (CPAA)
Address [1] 251571 0
Hampstead Rehab Centre
Hampstead Rd
Northfield, SA 5085
Country [1] 251571 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258333 0
Royal Adelaide Hospital
Ethics committee address [1] 258333 0
Ethics committee country [1] 258333 0
Australia
Date submitted for ethics approval [1] 258333 0
08/01/2010
Approval date [1] 258333 0
13/01/2010
Ethics approval number [1] 258333 0

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

Contacts
Principal investigator
Name 30659 0
Address 30659 0
Country 30659 0
Phone 30659 0
Fax 30659 0
Email 30659 0
Contact person for public queries
Name 13906 0
Dr Amanda Foley-Gooding
Address 13906 0
Centre for Physical Activity in Ageing (CPAA)
Hampstead Rehabilitation Centre
Hampstead Rd
Northfield, SA, 5085
Country 13906 0
Australia
Phone 13906 0
+61 8 8222 1782
Fax 13906 0
+61 8 8222 1828
Email 13906 0
[email protected]
Contact person for scientific queries
Name 4834 0
Dr Amanda Foley-Gooding
Address 4834 0
Centre for Physical Activity in Ageing (CPAA)
Hampstead Rehab Centre
Hampstead Rd
Northfield, SA, 5085
Country 4834 0
Australia
Phone 4834 0
+61 8 8222 1782
Fax 4834 0
+61 8 8222 1828
Email 4834 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.