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Trial registered on ANZCTR


Registration number
ACTRN12617000343303
Ethics application status
Approved
Date submitted
1/03/2017
Date registered
6/03/2017
Date last updated
6/08/2019
Date data sharing statement initially provided
6/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing Language Learning in Ageing with Exercise.
Scientific title
Enhancing language learning with exercise in healthy older adults.
Secondary ID [1] 291336 0
Nil
Universal Trial Number (UTN)
U1111-1193-6401
Trial acronym
The ELLA study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Language impairments 302297 0
Condition category
Condition code
Neurological 301883 301883 0 0
Neurodegenerative diseases
Neurological 301885 301885 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During visit 1, participants will undergo a cognitive assessment and a fitness test.
One week later, participants will return to the lab for a second visit.

During visit 2, each participant will be randomly assigned to one of the three following exercise condition: 1) stretching 2) moderate intensity aerobic exercise and 3) high intensity aerobic exercise. The acute bout of exercise will be completed after the blood draw has taken place. Subjects will engage in either stretching (gentle upper and lower extremity stretching) for 38 minutes, moderate-intensity cycling for 38 minutes (50-75% V02 max) or high intensity cycling for 33 minutes (85-95% V02 max). During the exercise session, subjects’ heart rate will be monitored during warm up, cool down and during the test to ensure they maintain their target. All three exercise conditions will be performed one-on-one in a gym at The University of Queensland School of Human Movement and Nutrition Sciences.

1) The stretching condition will provide interaction with a researcher without increasing the subject’s heart rate and is commonly employed as a control. To ensure this is achieved, heart rate will be monitored during the session.

2) The moderate intensity aerobic exercise condition will be conducted on a Watt Bike for a total of 38 minutes per session. A five minute warm up and a three minute cool down will be conducted at 50-60% of HRmax. The participant will cycle for 30 minutes at an intensity of 50-65% of HRmax.

3) The high intensity aerobic exercise condition will be conducted on a Watt bike for a total of 33 minutes per session. A warm up of five minutes and a cool down of three minutes will be conducted at an intensity of 50-60% HRmax. The high intensity interval training will alternate periods of work with active recovery. The exercise protocol will be 4x4min bouts at 85-95% of HRmax. An active recovery (50-65% HRmax) for three minutes will follow each four minute high intensity bout.

One week later, participants will return to the lab for a third visit (follow-up) where they will undergo a recall and a recognition word learning task and will complete a questionnaire on the strategies used during word learning.

Therefore, each participant will attend 3 visits within a period of 2 weeks.
Visit 1: day 1 (cognitive assessment and fitness test)
Visit 2: day 8 (blood draw pre-exercise, acute exercise bout, post-exercise blood draw, word learning task*, post-learning blood draw)
Visit 3: day 15 (follow-up recall and recognition task**, word learning strategies)

* The word learning task during visit 2 includes 5 learning trials interspersed with 5 recalls and a recognition task and the total end. This word learning task assesses the initial acquisition of new words.

** The word learning task during visit 3 only includes 1 recall and 1 recognition task for memory consolidation purposes of the new words that were presented during visit 2.

Intervention code [1] 297349 0
Treatment: Other
Comparator / control treatment
The stretching group described in the intervention section will be used as the control group.
Control group
Placebo

Outcomes
Primary outcome [1] 301309 0
Performance at a computerised associative word learning task designed specifically for this trial using 15 familiar objects paired with 15 nonwords from Gupta et al. (2004).
Timepoint [1] 301309 0
Immediately after the single bout of exercise for initial acquisition purposes and one week later for consolidation purposes.
Primary outcome [2] 301310 0
Learning-related bio-marker levels in the blood will be assessed (neurotrophins and neurotransmitters). This includes dopamine, epinephrine, norepinephrine, brain-derived neurotrophic factor (BDNF), glucose, insulin, APOE, CRP, cytokine panel and lactate levels.
Timepoint [2] 301310 0
All three blood draws are performed within the same day (during visit 2).
1. Blood draw #1 : before exercising.
2. Acute bout of exercise (either stretching, moderate-intensity cycling or high-intensity cycling.
3. Blood draw #2: after exercising.
4. Word learning task.
5. Blood draw #3: after learning.

All three blood draws will be performed during visit 2 within an approximately 2 hour period.
Secondary outcome [1] 332318 0
nil
Timepoint [1] 332318 0
nil

Eligibility
Key inclusion criteria
Subjects
For this study, 60 healthy older adults (age 60-85) will be recruited meeting the following criteria.

Inclusion criteria
English as primary language, low to moderate physical activity (as per International Physical Activity Questionnaire, Craig et al., 2003), doctor’s approval for participation in high intensity exercise.
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
History of developmental learning or speech-language disorder, neurological injury or disease, mental illness, chronic severe medical illness, any contraindication to high-intensity exercise, use of hormone replacement therapy, cognitive impairment (as indicated by performance on the Montreal Cognitive Assessment (Nasreddine et al., 2005)), uncorrected hearing or vision impairments.

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)
Allocation concealed:
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods such as Minimisation.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/03/2017
Actual
2/05/2017
Date of last participant enrolment
Anticipated
Actual
29/03/2018
Date of last data collection
Anticipated
Actual
19/04/2018
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 295727 0
Government body
Name [1] 295727 0
Australian Research Council
Country [1] 295727 0
Australia
Primary sponsor type
Individual
Name
David Copland
Address
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 294634 0
None
Name [1] 294634 0
Address [1] 294634 0
Country [1] 294634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297030 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 297030 0
Ethics committee country [1] 297030 0
Australia
Date submitted for ethics approval [1] 297030 0
05/08/2016
Approval date [1] 297030 0
17/11/2016
Ethics approval number [1] 297030 0
2016001192

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

Contacts
Principal investigator
Name 72766 0
Prof David Copland
Address 72766 0
The University of Queensland
St Lucia QLD 4072
Country 72766 0
Australia
Phone 72766 0
+61 7 334 65539
Fax 72766 0
+61 7 336 52817
Email 72766 0
[email protected]
Contact person for public queries
Name 72767 0
David Copland
Address 72767 0
The University of Queensland
St Lucia QLD 4072
Country 72767 0
Australia
Phone 72767 0
+61 7 334 65539
Fax 72767 0
+61 7 336 52817
Email 72767 0
[email protected]
Contact person for scientific queries
Name 72768 0
David Copland
Address 72768 0
The University of Queensland
St Lucia QLD 4072
Country 72768 0
Australia
Phone 72768 0
+61 7 334 65539
Fax 72768 0
+61 7 336 52817
Email 72768 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
We do not have ethical approval to make this data available.


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.