Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000082303
Ethics application status
Approved
Date submitted
11/01/2017
Date registered
16/01/2017
Date last updated
23/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of reducing sitting time on cognitive function in frail and inactive older adults..
Scientific title
A randomised controlled trial into the effect of reducing prolonged sitting on cognitive function in insufficiently active frail older adults.
Secondary ID [1] 289654 0
Nil
Universal Trial Number (UTN)
Trial acronym
RESCUE (REducing Sitting to improve Cognitive fUnction in Elders)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive function 299452 0
Condition category
Condition code
Public Health 299433 299433 0 0
Health promotion/education
Neurological 301335 301335 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention duration is 12 weeks and is comprised of one face-to-face consultation session (1 hour in week 1) and five telephone calls (10-20 minutes each in weeks 2, 3, 5, 8, 12). The intervention is delivered by a research assistant working in geriatric medicine who has training in delivering behaviour change interventions. The intervention is based on content contained in a workbook given to participants in the face-to-face session. This workbook contains six modules:
1. Sitting and your health
2. Taking action
3. Using your sitting influences to your advantage
4. Don't take set-backs sitting down!
5. 8 Lifestyle Habits to boos your brain health further!
6. Reflection and forward planning
Modules are designed to be completed during each contact point, e.g. the face-to-face session and telephone calls. Participants will be asked to complete homework (10-20 minutes) during the face-to-face session and prior to each telephone call.

The two key guidelines of the intervention are:
1. Stand for 3 @ 30. Participants are encouraged to stand up and move for 3 minutes after every 30 minutes of uninterrupted sitting.
2. Sit less throughout the day. Participants are encouraged to replace activities done while sitting down for those that can be done while standing.
Participants will set action plans to try and achieve the intervention guidelines. They will also complete trackers to monitor their progress.

During the face-to-face session conducted in the home of the participants, they will receive information about sitting time and health, the potential benefits of reducing prolonged periods of sitting and feedback on their objectively measured sitting time. They will also receive a device (Jawbone UP2) to wear on the wrist for the duration of the intervention. This device will prompt them to move after 30 minutes of uninterrupted sitting.

During the telephone calls, participants will be asked about their program, and their progress in reducing their sitting time. Their action plans and trackers will be reviewed and they will receive feedback on their homework.
Intervention code [1] 295277 0
Behaviour
Intervention code [2] 295286 0
Lifestyle
Intervention code [3] 296843 0
Prevention
Comparator / control treatment
Participants in the control group (or program materials only group) will undergo assessments at baseline, 12- and 24-weeks. During the intervention period they do not receive any program materials or contact with the researchers. At the completion of the intervention period and after the 12-week assessment, they will be sent the intervention materials, i.e. workbook, feedback on their objectively measured sitting time and Jawbone Up2.
Control group
Active

Outcomes
Primary outcome [1] 298902 0
Cognitive function: change in performance accuracy (words recalled) measured via California Verbal Learning Test - Second Edition (CVLT Registered Trademark -II)
Timepoint [1] 298902 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [1] 325595 0
Sedentary time; measured objectively via activPAL3 inclinometer using a 7 day continuous wear protocol
Timepoint [1] 325595 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [2] 325596 0
Cognitive function: change in a composite score that covers different aspects of cognitive function as assessed by CANTAB tests: sensorimotor function and comprehension assessed by the Motor Control Task test; visual episodic memory (Paired Associates Learning test); attention and short term visual memory (Delayed Matching to Sample test); working memory and strategy (Spatial Working Memory test); processing and psychomotor speed (Reaction Time test), and, sustained attention (Rapid Visual Information Processing test).
Timepoint [2] 325596 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [3] 325597 0
Cognitive function: change in selective attention and the ability to inhibit habitual responses measured by the California Older Adult Stroop Test.
Timepoint [3] 325597 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [4] 325598 0
Cognitive function: change in visual search, scanning, speed of processing, mental flexibility, and executive functions measured by the Trail Making Test.
Timepoint [4] 325598 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [5] 325599 0
Body composition: change in % body fat measured by dual-energy x-ray absorptiometry (DEXA) scans
Timepoint [5] 325599 0
Baseline, 12 weeks
Secondary outcome [6] 325646 0
Sarcopenia: change in sarcopenia status. Sarcopenia status will be defined using the European Working Group Definition and determined from muscle mass (from dual-energy x-ray absorptiometry (DEXA) scans), muscle strength (hand grip strength measured by dynamometer), and physical performance (measured by the short physical performance battery).
Timepoint [6] 325646 0
Baseline, 12 weeks
Secondary outcome [7] 325647 0
Frailty: change in frailty status measured by FRAIL scale
Timepoint [7] 325647 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [8] 330326 0
Sleep: change in sleep quality measured by the Pittsburgh Sleep Quality Index
Timepoint [8] 330326 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [9] 330727 0
Anxiety: change measured by the Geriatric Anxiety Index
Timepoint [9] 330727 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [10] 330728 0
Depression: change in depressive symptoms measured by the Geriatric Depression Scale
Timepoint [10] 330728 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [11] 330730 0
Quality of life as measured by the Medical Outcomes Study short form 36 questionnaire (SF-36)
Timepoint [11] 330730 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [12] 330731 0
Biomarkers: change in fasting glucose as measured by plasma assay
Timepoint [12] 330731 0
Baseline, 12 weeks
Secondary outcome [13] 330736 0
Biomarkers: change in insulin as measured by serum assay
Timepoint [13] 330736 0
Baseline, 12 weeks
Secondary outcome [14] 330737 0
Biomarkers: change in cholesterol (total and HDL-C) as measured by plasma assay
Timepoint [14] 330737 0
Baseline, 12 weeks

Eligibility
Key inclusion criteria
Participants are eligible if they fulfill the following criteria:
1) aged 60 years or older; 2) living in community dwelling; 3) not in paid employment; 4) no known diagnosis of dementia; 5) “insufficiently active”, defined as doing less than 60 minutes/week of moderate- to vigorous-intensity physical activity for at least the previous 3 months; 6) “frail” defined as having 3 or more deficits related to fatigue, resistance, ambulation, illness and loss of weight on the FRAIL scale.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are excluded if they meet any of the following criteria:
1) presence of medical condition that prohibits standing; 2) unstable or life threatening medical condition; severe visual or hearing impairment; 3) unable to commit to the assessment schedule; 4) unable to understand spoken or written English.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome will be change in performance accuracy (words recalled) on the CVLT-II between baseline and the 12-week assessment. Sample size calculation was based on the following assumptions: power = 0.80; 2-sided alpha = 0.05 based on pilot data from the AusDiab3 dataset. Mean CVLT scores between the lowest and highest quartiles of self-reported sitting time [lowest: 3-34 hours sitting per week, mean (SD) = 5.65 (2.17); highest: = 60 hrs per week, mean (SD) = 6.81 (2.23)] were compared. Based on these data, 57 participants are required in each group. Allowing for a 20% drop out rate, the target sample size is 72 participants per group.

Further statistical considerations include:
- intention-to-treat basis (with baseline values carried forward for missing data) to determine whether the intervention group differs from the control group in changes over time on all primary and secondary outcomes;
- Repeated measures regression models, using generalised estimating equations (GEE) with the treatment group as the main effect and the group by time interaction, for the primary outcome (verbal learning and memory from the CVLT II) and each of the secondary outcomes;
- Potential confounders specific to each dependent variable will be identified and controlled via statistical adjustment;
- Statistical significance will be set at the conventional 5% level (two-tailed).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/02/2017
Actual
20/10/2017
Date of last participant enrolment
Anticipated
29/06/2018
Actual
Date of last data collection
Anticipated
14/12/2018
Actual
Sample size
Target
144
Accrual to date
45
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 13592 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 294041 0
Other
Name [1] 294041 0
Dementia Collaborative Research Centre
Country [1] 294041 0
Australia
Funding source category [2] 295216 0
Government body
Name [2] 295216 0
Australian National Health and Medical Research Council (NHMRC)
Country [2] 295216 0
Australia
Funding source category [3] 295327 0
Government body
Name [3] 295327 0
Australian Research Council (ARC)
Country [3] 295327 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Centre for Health Services Research
Level 2, Building 33
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 292864 0
None
Name [1] 292864 0
Address [1] 292864 0
Country [1] 292864 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295458 0
University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 295458 0
The University of Queensland
Cumbrae-Stewart Building
Research Road
Brisbane Qld 4072 Australia
Ethics committee country [1] 295458 0
Australia
Date submitted for ethics approval [1] 295458 0
Approval date [1] 295458 0
30/11/2016
Ethics approval number [1] 295458 0
2016001335

Summary
Brief summary
In a novel approach we propose a randomised controlled trial to investigate the cognitive benefits of reducing prolonged sitting in adults aged 60 years and older with two risk factors for cognitive decline: being frail and not meeting physical activity guidelines. The 16-week theory-informed sitting reduction program will include one face-to-face session and five telephone calls. Participants will receive normative feedback on their objectively measured sitting time, work through a series of activities in a workbook and set goals which they will integrate incrementally. 144 older adults will be randomised to receive either the sitting reduction program or a control condition. Participants will be assessed at baseline, at end of intervention at 16 weeks and at 32 weeks to assess maintenance. Primary outcome is cognitive function assessed with the California Verbal Learning Test with secondary outcomes of objectively measured sitting time, executive function, mental wellbeing (anxiety and depressive symptoms, and quality of life), and body composition (waist circumference, weight, and % body fat) and sleep (duration and quality).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67342 0
Dr Paul Gardiner
Address 67342 0
The University of Queensland
Centre for Health Services Research
Level 2, Building 33
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 67342 0
Australia
Phone 67342 0
+61 7 3176 6420
Fax 67342 0
Email 67342 0
p.gardiner@uq.edu.au
Contact person for public queries
Name 67343 0
Dr Paul Gardiner
Address 67343 0
The University of Queensland
Centre for Health Services Research
Level 2, Building 33
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 67343 0
Australia
Phone 67343 0
+61 7 3176 6420
Fax 67343 0
Email 67343 0
p.gardiner@uq.edu.au
Contact person for scientific queries
Name 67344 0
Dr Paul Gardiner
Address 67344 0
The University of Queensland
Centre for Health Services Research
Level 2, Building 33
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 67344 0
Australia
Phone 67344 0
+61 7 3176 6420
Fax 67344 0
Email 67344 0
p.gardiner@uq.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

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