Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000092695
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
5/08/2005
Date last updated
5/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is exercising once a week enough to maintain the strength and function of older adults post discharge from a day rehab centre?
Scientific title
The effectiveness of a once a week, community-based exercise program
in maintaining the physical function, independence and program adherence
of older adults post physical rehabilitation.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
musculo-skeletal degeneration 172 0
Injury or deconditioning involving the spine and/or lower limbs 173 0
Condition category
Condition code
Musculoskeletal 192 192 0 0
Other muscular and skeletal disorders
Injuries and Accidents 193 193 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 194 194 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High intensity, community based exercise performed once vs twice a week
Intervention code [1] 94 0
Rehabilitation
Comparator / control treatment
he control group is usual care- participants will be offered either the opportunity to continue exercising (at their own cost and without transport provided) or to attend a 6 week course of hydro or functional mobility once a week, or no further treatment after discharge
Control group
Active

Outcomes
Primary outcome [1] 233 0
Timed up and Go Test (Physical Function)
Timepoint [1] 233 0
Measurements taken at baseline (on admission to DRC), at discharge from the Day Rehab Centre, at 12 weeks post discharge and at 12 months post discharge
Primary outcome [2] 234 0
1-Repetition Maximum (Muscle Strength)
Timepoint [2] 234 0
Measurements taken at baseline (on admission to DRC), at discharge from the Day Rehab Centre, at 12 weeks post discharge and at 12 months post discharge
Secondary outcome [1] 524 0
Glasgow Pain Scale
Timepoint [1] 524 0
Measurements will be collected at baseline (on admission to the DRC), at discharge from the DRC, at 12 weeks post discharge and at 9 months post discharge from the DRC.
Secondary outcome [2] 525 0
Berg Balance Scale
Timepoint [2] 525 0
Measurements will be collected at baseline (on admission to the DRC), at discharge from the DRC, at 12 weeks post discharge and at 9 months post discharge from the DRC.
Secondary outcome [3] 526 0
Patient Specific Scale
Timepoint [3] 526 0
Measurements will be collected at baseline (on admission to the DRC), at discharge from the DRC, at 12 weeks post discharge and at 9 months post discharge from the DRC.
Secondary outcome [4] 527 0
Barthel Index & OARS MFAQ
Timepoint [4] 527 0
Measurements will be collected at baseline (on admission to the DRC), at discharge from the DRC, at 12 weeks post discharge and at 9 months post discharge from the DRC.
Secondary outcome [5] 528 0
Falls Efficacy Scale
Timepoint [5] 528 0
Measurements will be collected at baseline (on admission to the DRC), at discharge from the DRC, at 12 weeks post discharge and at 9 months post discharge from the DRC.
Secondary outcome [6] 529 0
Exercise Benefits/Barriers Scale
Timepoint [6] 529 0
Measurements will be collected at baseline (on admission to the DRC), at discharge from the DRC, at 12 weeks post discharge and at 9 months post discharge from the DRC.
Secondary outcome [7] 530 0
Gait speed
Timepoint [7] 530 0
Measurements will be collected at baseline (on admission to the DRC), at discharge from the DRC, at 12 weeks post discharge and at 9 months post discharge from the DRC.
Secondary outcome [8] 531 0
30-Second Chair Stand Test
Timepoint [8] 531 0
Measurements will be collected at baseline (on admission to the DRC), at discharge from the DRC, at 12 weeks post discharge and at 9 months post discharge from the DRC.
Secondary outcome [9] 532 0
Six-minute Walk Test
Timepoint [9] 532 0
Measurements will be collected at baseline (on admission to the DRC), at discharge from the DRC, at 12 weeks post discharge and at 9 months post discharge from the DRC.
Secondary outcome [10] 533 0
AQol.
Timepoint [10] 533 0
Measurements will be collected at baseline (on admission to the DRC), at discharge from the DRC, at 12 weeks post discharge and at 9 months post discharge from the DRC.

Eligibility
Key inclusion criteria
Primary diagnosis of musculo-skeletal impairment involving the spine and/or lower limbs or non-specific general de-conditioning and reduced functional mobility.Attended Day Rehabilitation Centre for initial assessment.Greater than or equal to 60 years of age.
Minimum age
60 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary diagnosis of neurological impairment or cardiac or respiratory dysfunction.Current client of the Day Rehabilitation CentreLess than 60 years of ageDiagnosed dementia or cognitively impaired.

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 envelopes, opened in sequential order by external party
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
12 month follow up
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 249 0
Government body
Name [1] 249 0
NHMRC
Country [1] 249 0
Australia
Funding source category [2] 250 0
Hospital
Name [2] 250 0
Royal Adelaide Hospital
Country [2] 250 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 190 0
Hospital
Name [1] 190 0
RAH
Address [1] 190 0
Country [1] 190 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1051 0
University of South Australia
Ethics committee address [1] 1051 0
Ethics committee country [1] 1051 0
Australia
Date submitted for ethics approval [1] 1051 0
Approval date [1] 1051 0
Ethics approval number [1] 1051 0
Ethics committee name [2] 1052 0
Royal Adelaide Hospital
Ethics committee address [2] 1052 0
Ethics committee country [2] 1052 0
Australia
Date submitted for ethics approval [2] 1052 0
Approval date [2] 1052 0
Ethics approval number [2] 1052 0

Summary
Brief summary
The proposed research project will investigate whether high-intensity, community-based exercise programs performed once a week are sufficient to maintain or improve a variety of subjective and objective outcomes including the physical function, balance, independence and program adherence of older adults post-discharge from a Day Rehabilitation Centre (DRC). The â¿¿once a weekâ¿¿ exercise intervention will be directly compared with â¿¿twice a weekâ¿¿ exercise, and with usual care for a period of 12 weeks post discharge. Participants will be followed up at the end of the intervention period and at 12 months post discharge from the DRC. The cost effectiveness of the interventions will also be determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35735 0
Address 35735 0
Country 35735 0
Phone 35735 0
Fax 35735 0
Email 35735 0
Contact person for public queries
Name 9283 0
Susan Hillier
Address 9283 0
Division Health Sciences
University of South Australia
North Tce
Adelaide SA 5000
Country 9283 0
Australia
Phone 9283 0
+61 8 83022544
Fax 9283 0
Email 9283 0
[email protected]
Contact person for scientific queries
Name 211 0
Amanda Foley
Address 211 0
Centre for Physical Activity and Ageing (CPAA)
Hampstead Rehabilitation Centre
207 - 255 Hampstead Rd
Northfield SA 5085
Country 211 0
Australia
Phone 211 0
+61 8 82221782
Fax 211 0
+61 8 82221828
Email 211 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.