Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000946213
Ethics application status
Approved
Date submitted
31/05/2018
Date registered
5/06/2018
Date last updated
4/02/2019
Date data sharing statement initially provided
4/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Group-based exercise physiology services for those aged over 50
Scientific title
The effectiveness of group-based exercise physiology services at alleviating multiple morbidities associated with ageing.
Secondary ID [1] 295056 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 308102 0
Osteoporosis
 308103 0
Fall risk 308104 0
Ageing 308127 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307142 307142 0 0
Other physical medicine / rehabilitation
Musculoskeletal 307160 307160 0 0
Osteoporosis
Musculoskeletal 307161 307161 0 0
Other muscular and skeletal disorders
Injuries and Accidents 307162 307162 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three treatment arms. The client will participate in one treatment arm dependent upon the risk factors identified for that individual. Treatments comprise 2 one-hour group-based sessions each week for 10 weeks. The first session each week is 100% exercise, the second session is 50% education and 50% exercise. All sessions are conducted by accredited exercise physiologists. Education content is delivered as an interactive presentation by the facilitator and participants are provided with workbooks containing the education content.
Sarcopenia
Exercise content: Progressive resistance training completed at Borg RPE level between 6 and 8: chest press, leg press, abdominal curl, leg curl, leg extension, rhomboid row, lat pull down. Cardiovascular warm up and stretching for cool down.
Education content: Introduction, strength training, nutrition, muscle hypertrophy and strength.
Osteoporosis
Exercise content: Combination balance exercises in circuit format – heel toe walking, stepping in a box pattern, single leg stand on foam, ball throwing and catching, step ups. Progressive resistance training completed at Borg RPE level between 6 and 8 – dead lifts, weighted squats, shoulder press. Moderate impact loading exercises – stomping, marching, bounding, jumping. Cardiovascular warm up and stretching for cool down.
Education content: Introduction, functional lifting, posture to reduce fracture risk, falls and fractures, exercise and bone health, osteoporosis and osteoarthritis.
Balance
Exercise content: Combination balance exercises in circuit format – heel toe walking, stepping in a box pattern, single leg stand on foam, ball throwing and catching, step ups. Lower body progressive resistance training completed at Borg RPE level between 6 and 8 – leg press, leg curl, leg extensions, hip abduction, hip adduction. Cardiovascular warm up and stretching for cool down.
Education content: Introduction, fall risk factors, fear of falling, role of exercise, lower body strength and falls, how to recover from a fall, osteoporosis and falls, environmental risk factors and hazard identification.

Session attendance records are kept to monitor participant attendance and compliance.
Intervention code [1] 301388 0
Prevention
Intervention code [2] 301389 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306096 0
Isometric leg strength measured by strain gauge
Timepoint [1] 306096 0
Baseline and at the end of the 10 week intervention.
Primary outcome [2] 306122 0
Grip strength measured by grip strength dynamometer
Timepoint [2] 306122 0
Baseline and at the end of the 10 week intervention.
Primary outcome [3] 306123 0
Lower body strength, endurance and muscular power measured by 30 second sit-to-stand
Timepoint [3] 306123 0
Baseline and at the end of the 10 week intervention.
Secondary outcome [1] 347563 0
Body composition as measured by BIA
Timepoint [1] 347563 0
Baseline and at the end of the 10 week intervention.
Secondary outcome [2] 347627 0
Quality of life measured using the EuroQoL 5D 3L
Timepoint [2] 347627 0
Baseline and at the end of the 10 week intervention.
Secondary outcome [3] 347628 0
Functional ability and fall risk measured by Timed up and go test
Timepoint [3] 347628 0
Baseline and at the end of the 10 week intervention.

Eligibility
Key inclusion criteria
Individuals aged 50 years or older who are independently mobile (including with a walking aid). Individuals with a history of, or at risk of, sarcopenia, osteoporosis or poor balance. Risk will be assessed using the clinical judgement of accredited exercise physiologists and will based in the major global risk factors of age and low physical activity levels. Per condition risk will be - Sarcopenia: low leg and grip strength. Osteoporosis: gender, menopause onset, body mass and family history. Poor balance: fall history, low leg strength and poor balance test performance.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who are clinically unstable with contraindications to exercise or those with cognitive impairment or intellectual disability that prevents them from providing personal informed consent to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/06/2018
Actual
24/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 25515 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 299638 0
Other
Name [1] 299638 0
Burnie Brae Ltd
Country [1] 299638 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Faculty of Health and Behavioural Sciences
School of Nursing, Midwifery & Social Work
Chamberlain Building
St Lucia Campus
Queensland 4072
Country
Australia
Secondary sponsor category [1] 298963 0
None
Name [1] 298963 0
Address [1] 298963 0
Country [1] 298963 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300536 0
The University of Queensland Human Research Ethics Committee - B
Ethics committee address [1] 300536 0
Ethics committee country [1] 300536 0
Australia
Date submitted for ethics approval [1] 300536 0
10/05/2018
Approval date [1] 300536 0
04/06/2018
Ethics approval number [1] 300536 0

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

Contacts
Principal investigator
Name 83982 0
Dr Sharon Hetherington
Address 83982 0
Burnie Brae
60 Kuran Street
Chermside
Queensland 4032
Country 83982 0
Australia
Phone 83982 0
+61736242186
Fax 83982 0
Email 83982 0
[email protected]
Contact person for public queries
Name 83983 0
Sharon Hetherington
Address 83983 0
Burnie Brae
60 Kuran Street
Chermside
Queensland 4032
Country 83983 0
Australia
Phone 83983 0
+61736242186
Fax 83983 0
Email 83983 0
[email protected]
Contact person for scientific queries
Name 83984 0
Sharon Hetherington
Address 83984 0
Burnie Brae
60 Kuran Street
Chermside
Queensland 4032
Country 83984 0
Australia
Phone 83984 0
+61736242186
Fax 83984 0
Email 83984 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.