Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000690459
Ethics application status
Approved
Date submitted
24/05/2016
Date registered
26/05/2016
Date last updated
1/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of resistance training for the prevention of cognitive decline.
Scientific title
Efficacy of resistance training for the prevention of cognitive decline in healthy older adults.
Secondary ID [1] 289261 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive decline 298840 0
Condition category
Condition code
Mental Health 298902 298902 0 0
Other mental health disorders
Neurological 298969 298969 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to either of the two resistance exercise group will be required to attend 12 weeks of twice a week resistance training of particular prescription (i.e. strength or hypertrophy). Session durations will be 70 minutes for strength training, and 30 minutes for hypertrophy training. The strength protocol will consist of five sets of five repetitions of a weight that can only be lifted maximally for five repetitions (i.e., 5 repetition maximum or 5 RM) followed by three minutes of passive recovery period between each set and exercise. The hypertrophy protocol will consist of three sets of ten repetitions at a 10 RM weight followed by one minute of passive recovery between sets and exercises. Sessions will be conducted by an accredited Exercise Physiologist at the Rehabilitation and Conditioning Laboratory at Murdoch University in small group sessions; however, one-on-one sessions will be common. Participants will perform four exercises per session at the respective RM and repetition range. The chosen exercises are bench press, incline leg press, latissimus dorsi pull-down and leg extension. As per participant tolerance, resistance will be increased from 2.5-5% per week over the intervention. Adherence will be monitored through attendance.
Intervention code [1] 294806 0
Prevention
Comparator / control treatment
A control group will run in parallel in which participants will be asked to maintain current lifestyle and exercise habits. Physical activity habits of all groups will be assessed using the International Physical Activity Questionnaire which will account for activity within the last 7 days.
Control group
Active

Outcomes
Primary outcome [1] 298374 0
Cognitive function will be assessed using the CogState battery plus Rey Complex Figure, Rey Auditory Verbal Learning Test, Controlled Oral Word Association Test, Category Fluency, Trail Making Test Parts A & B, Montreal Cognitive Assessment, Digit Span and Digit Symbol Substitution Test.
Timepoint [1] 298374 0
Baseline and 12 weeks.
Secondary outcome [1] 323963 0
Frontal lobe tissue oxygenation via near-infrared spectroscopy
Timepoint [1] 323963 0
Baseline and 12 weeks.
Secondary outcome [2] 323964 0
Brain-derived neurotrophic factor by serum ELISA.
Timepoint [2] 323964 0
Baseline and 12 weeks.
Secondary outcome [3] 323965 0
Insulin-like growth factor 1 by serum ELISA.
Timepoint [3] 323965 0
Baseline and 12 weeks.
Secondary outcome [4] 323966 0
Vascular endothelial growth factor by plasma ELISA.
Timepoint [4] 323966 0
Baseline and 12 weeks.
Secondary outcome [5] 323967 0
Endothelial nitric oxide synthase by plasma ELISA.
Timepoint [5] 323967 0
Baseline and 12 weeks.
Secondary outcome [6] 323968 0
Body composition via dual-energy x-ray absorptiometry
Timepoint [6] 323968 0
Baseline, 6 weeks, 12 weeks.

Eligibility
Key inclusion criteria
Considered low to moderate risk for moderate intensity exercise as per Exercise and Sports Science Australia risk stratification. Participants should be considered healthy.
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have more than two risk factors in the Exercise and Sports Science Australia pre-exercise screening tool questionnaire
2. Present with chronic musculoskeletal disease or injury
3. Show signs of mild cognitive impairment or dementia
4. Are a current smoker
5. Are currently taking selective serotonin reuptake inhibitor medication (Citalopram [Celexa], Escitalopram [Lexapro], Fluoxetine [Prozac], Paroxetine [Paxil, Pexeva] or Sertraline [Zoloft])
6. Have a history of neurological disease

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 is not concealed. Automatic allocation to treatment groups using minimisation software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation and stratifying for age, gender and APOE 4 carrier status.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proposed sample size was calculated at a power of 80% and alpha level of 0.05 based on the magnitude of change (Cohen’s d = 0.4; f = 0.2) necessary to observe a small to moderate change in cognitive function between conditions. Linear mixed modelling will be used to assess changes in blood biomarkers and cognitive function scores pre- to post- exercise intervention, and for changes between intervention conditions. Significant main effects or interactions will be assessed using a Fisher’s LSD post hoc analysis. All statistics will be analysed using SPSS (v.22, IBM; USA) with the level of significance set to p=0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2016
Actual
26/08/2016
Date of last participant enrolment
Anticipated
Actual
28/07/2017
Date of last data collection
Anticipated
Actual
12/12/2017
Sample size
Target
45
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 293644 0
University
Name [1] 293644 0
School of Psychology and Exercise Science, Murdoch University
Country [1] 293644 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch, WA, 6150
Country
Australia
Secondary sponsor category [1] 292499 0
None
Name [1] 292499 0
Address [1] 292499 0
Country [1] 292499 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295103 0
Murdoch University Human Research Ethics & Integrity
Ethics committee address [1] 295103 0
Ethics committee country [1] 295103 0
Australia
Date submitted for ethics approval [1] 295103 0
26/04/2016
Approval date [1] 295103 0
19/05/2016
Ethics approval number [1] 295103 0
2016052

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

Contacts
Principal investigator
Name 66030 0
Mr Kieran Marston
Address 66030 0
Murdoch University
90 South Street
Murdoch
WA
6150
Country 66030 0
Australia
Phone 66030 0
+61433972216
Fax 66030 0
Email 66030 0
[email protected]
Contact person for public queries
Name 66031 0
Jeremiah Peiffer
Address 66031 0
Murdoch University
90 South Street
Murdoch
WA
6150
Country 66031 0
Australia
Phone 66031 0
+61 8 9360 7603
Fax 66031 0
Email 66031 0
[email protected]
Contact person for scientific queries
Name 66032 0
Jeremiah Peiffer
Address 66032 0
Murdoch University
90 South Street
Murdoch
WA
6150
Country 66032 0
Australia
Phone 66032 0
+61 8 9360 7603
Fax 66032 0
Email 66032 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.