Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000534684
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
28/09/2005
Date last updated
28/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promotion of healthy aging in Northern Tasmania: the benefits to older adults of resistance training
Scientific title
The effects of resistance training versus flexibility training on cognitive function, quality of life and mood, muscular control and fitness, and cardiovascular function in older adults: a randomized crossover trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Promotion of healthy aging 659 0
Psychological and physiological intermediates for cerebrovascular and cardiovascular disease 660 0
Condition category
Condition code
Public Health 732 732 0 0
Health promotion/education
Cardiovascular 733 733 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects undergo 2 exercise periods of 4 months each with order allocated at random: a) resistance training based on the living Longer Living Stronger Program (Council of Ageing Tasmania) with 2 supervised gym and 1 unsupervised home session per week; b) flexibility training with 2 supervised gym and 1 unsupervised home session per week. Each session will last 30-60 minutes
Intervention code [1] 588 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 903 0
a) cognitive function, quality of life and mood assessment
Timepoint [1] 903 0
Measured at start, 2 months and 4 months
Primary outcome [2] 904 0
b) muscle strength and cardiovascular fitness
Timepoint [2] 904 0
Measured at start, 2 months and 4 months
Secondary outcome [1] 1760 0
a) Blood pressure and vascular compliance
Timepoint [1] 1760 0
Each measured at start, 2 months and 4 months.
Secondary outcome [2] 1761 0
b) influence of ACE genotype.
Timepoint [2] 1761 0
Genotype measured at start.

Eligibility
Key inclusion criteria
Willing to undertake an exercise program in the Launceston and North-west Coast regions of Tasmania.
Minimum age
60 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing symptomatic cerebrovascular, cardiovascular disease or dementia, diabetes or hypertension.

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)
Allocation following recruitment, concealed by blinded list held by investigator independent of participant or research officer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 814 0
Charities/Societies/Foundations
Name [1] 814 0
Clifford Craig Medical Research Trust
Country [1] 814 0
Australia
Funding source category [2] 815 0
Charities/Societies/Foundations
Name [2] 815 0
North-west Medical Research Trust
Country [2] 815 0
Australia
Primary sponsor type
University
Name
School of Human Life Sciences, University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 681 0
University
Name [1] 681 0
School of Psychology, University of Tasmania
Address [1] 681 0
Country [1] 681 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2081 0
HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK: Medical
Ethics committee address [1] 2081 0
Ethics committee country [1] 2081 0
Australia
Date submitted for ethics approval [1] 2081 0
Approval date [1] 2081 0
Ethics approval number [1] 2081 0

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

Contacts
Principal investigator
Name 36339 0
Address 36339 0
Country 36339 0
Phone 36339 0
Fax 36339 0
Email 36339 0
Contact person for public queries
Name 9777 0
Dr Andrew Williams
Address 9777 0
School of Human Life Sciences
University of Tasmania
Locked Bag 1320
Launceston Tasmania 7250
Country 9777 0
Australia
Phone 9777 0
+61 3 63245487
Fax 9777 0
+61 3 63243658
Email 9777 0
andrew.williams@utas.edu.au
Contact person for scientific queries
Name 705 0
Professor Madeleine Ball
Address 705 0
School of Human Life Sciences
University of Tasmania
Locked Bag 1320
Launceston Tasmania 7250
Country 705 0
Australia
Phone 705 0
+61 3 63485480
Fax 705 0
+61 3 63243658
Email 705 0
madeleine.ball@utas.edu.au

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes A.D. Williams et al. Journal of Science and Medic... [More Details]

Documents added automatically
No additional documents have been identified.