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Trial registered on ANZCTR


Trial ID
ACTRN12612000451808
Ethics application status
Approved
Date submitted
14/04/2012
Date registered
23/04/2012
Date last updated
24/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a multi-modal exercise program on cognition and physical functioning in older women: a randomised controlled trial.
Scientific title
The effects of a multi-modal exercise program compared to no exercise on cognition and physical functioning in older women: a randomised controlled trial.
Secondary ID [1] 280375 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age related cognitive decline 286290 0
Age related physical decline 286291 0
Condition category
Condition code
Public Health 286524 286524 0 0
Health promotion/education
Neurological 286525 286525 0 0
Studies of the normal brain and nervous system
Musculoskeletal 286526 286526 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a programme of multi-model exercise classes delivered twice weekly, for a period of 16-weeks. Classes are conducted for 60 minutes and the overall program is designed to include progressions and variations. Each session includes aerobic (cardiovascular), strength (resistance) and motor fitness (balance, co-ordination, flexibility and agility) training. Sessions are conducted by accredited fitness instructors, with a maximum of 20 participants and an instructor-to-participant ratio of 1:10.
Intervention code [1] 284683 0
Lifestyle
Intervention code [2] 284684 0
Prevention
Comparator / control treatment
Non-exercising controls
Control group
Active

Outcomes
Primary outcome [1] 287014 0
Cognitive test performance related to executive functions: working memory (Letter-Number Sequencing Test), inhibition (Stroop test), shifting (Trailmaking Test Parts A & B), simple and complex reaction time (1 choice and 5 choice - computer based assessment), verbal fluency (Controlled Oral Word Association Test).
Timepoint [1] 287014 0
Baseline and 16 weeks
Secondary outcome [1] 297054 0
Anthropometric values (circumference at the waist and hip; resting heart rate and blood pressure)
Timepoint [1] 297054 0
Baseline and 16 weeks
Secondary outcome [2] 297203 0
Blood serum levels of brain derived neutrophic factor (BDNF).
Timepoint [2] 297203 0
Baseline and 16 weeks
Secondary outcome [3] 297204 0
Physical functioning as measured by the six-minute walk test, the timed up and go test and the one-leg stance test
Timepoint [3] 297204 0
Baseline and 16 weeks

Eligibility
Key inclusion criteria
Potential participants will be included in the study if they are:
Female
Aged 65-75 years
Have normal cognitive function as assessed by the telephone interview of cognitive status (TICS).
Minimum age
65 Years
Maximum age
75 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People are excluded from the study if they score below 21 on the Telephone Interview of Cognitive Status (TICS); or if they are unable to obtain written clearance from a General Practitioner for serious health problems such as unstable heart or metabolic conditions. Individuals are also ineligible where there is a diagnosis of dementia or Parkinson’s disease or there is a report of a recent head injury.

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)
Following screening, consent and baseline data collection, participants will be randomly allocated to either intervention or control group using an automated randomisation service. The randomisation service provided by The Clinical Trials Coordinating Centre (CTCC) (Griffith University, Queensland, Australia) is accessed either by telephone or using web-based technology.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified random sampling (stratified by venue for exercise class) will be automated using the computerised system of the CTCC. A permuted block design will be employed.
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
Not yet recruiting
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 in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5237 0
4218
Recruitment postcode(s) [2] 5238 0
4220
Recruitment postcode(s) [3] 5239 0
4224
Recruitment postcode(s) [4] 5240 0
4225
Recruitment postcode(s) [5] 5241 0
4215

Funding & Sponsors
Funding source category [1] 285100 0
University
Name [1] 285100 0
Griffith University
Address [1] 285100 0
School of Physiotherapy and Exercise Science
Gold Coast Campus
Griffith University
QLD 4222
Country [1] 285100 0
Australia
Primary sponsor type
Individual
Name
Sue Vaughan
Address
School of Physiotherapy and Exercise Science
Gold Coast Campus
Griffith University
QLD 4222
Country
Australia
Secondary sponsor category [1] 283961 0
None
Name [1] 283961 0
Address [1] 283961 0
Country [1] 283961 0
Other collaborator category [1] 260737 0
Individual
Name [1] 260737 0
Professor Norm Morris
Address [1] 260737 0
School of Physiotherapy and Exercise Science
Gold Coast Campus
Griffith University
QLD 4222
Country [1] 260737 0
Australia
Other collaborator category [2] 260738 0
Individual
Name [2] 260738 0
Professor David Shum
Address [2] 260738 0
School of Applied Psychology
Mt Gravatt campus, Griffith University,
176 Messines Ridge Road,
Mt Gravatt QLD 4122
Country [2] 260738 0
Australia
Other collaborator category [3] 260739 0
Individual
Name [3] 260739 0
Dr Siobhan O'Dwyer
Address [3] 260739 0
Research Centre for Clinical and Community Practice Innovation,
Nathan campus,
Griffith University,
170 Kessels Road
QLD 4111
Country [3] 260739 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287116 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 287116 0
Chair, Human Research Ethics Committee
Gold Coast Campus
Griffith University
QLD 4222
Ethics committee country [1] 287116 0
Australia
Date submitted for ethics approval [1] 287116 0
Approval date [1] 287116 0
27/03/2012
Ethics approval number [1] 287116 0
PES/05/12/HREC

Summary
Brief summary
In order to cope with population ageing it is vital that safe, affordable and effective strategies, to arrest or delay cognitive decline, are developed. Research over 30 years has indicated that physical exercise produces small to moderate effects on cognition. Recent studies indicate motor fitness, compared to physical fitness, has different effects on cognition. This randomised controlled trial will test the efficacy of a novel, complex, community-based exercise program, in healthy women aged 65-75 years. The outcomes measured will include cognitive and physical functioning and serum levels of biomarkers related to cognitive functioning.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34067 0
Address 34067 0
Country 34067 0
Phone 34067 0
Fax 34067 0
Email 34067 0
Contact person for public queries
Name 17314 0
Sue Vaughan
Address 17314 0
C/o School of Physiotherapy and Exercise Science
Griffith University
Gold Coast Campus
QLD 4222
Country 17314 0
Australia
Phone 17314 0
+61 (0) 405 536 994
Fax 17314 0
Email 17314 0
sue.vaughan@griffithuni.edu.au
Contact person for scientific queries
Name 8242 0
Sue Vaughan
Address 8242 0
C/o School of Physiotherapy and Exercise Science
Griffith University
Gold Coast Campus
QLD 4222
Country 8242 0
Australia
Phone 8242 0
+61 (0) 405 536 994
Fax 8242 0
Email 8242 0
sue.vaughan@griffithuni.edu.au