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Trial registered on ANZCTR


Registration number
ACTRN12622000599774
Ethics application status
Approved
Date submitted
14/03/2022
Date registered
21/04/2022
Date last updated
31/08/2023
Date data sharing statement initially provided
21/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a 12-week telehealth delivered environmental enrichment program for young stroke survivors
Scientific title
The feasibility and therapeutic utility of a 12-week telehealth delivered environmental enrichment program for young stroke survivors
Secondary ID [1] 306461 0
Nil
Universal Trial Number (UTN)
U1111-1274-5988
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 325309 0
Condition category
Condition code
Stroke 322703 322703 0 0
Haemorrhagic
Stroke 323131 323131 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The environmental enrichment (EE) program is informed by previous research in stroke and our work in neurodegenerative disorders and comprises 12-weeks of exercise training, cognitive training, green-blue light therapy, healthy eating and sleep guidance. Exercise training will be prescribed by an exercise physiologist and will be periodised and consist of 60 minutes of moderate to vigorous intensity aerobic (40-70% heart rate reserve [HRR]) and resistance (rate of perceived exertion (RPE) 10-16) exercise three times per week. Exercise training will be programmed on HRR, repetition in reserve and rate of perceived exertion metrics. Aerobic training will consist of walking, cycling and swimming activities. Resistance training will consist of body weight and resistance tubing exercises and will target major muscle groups. Aerobic and resistance exercise will be counterbalanced during the intervention (30 minutes each). Computerised cognitive training will be undertaken remotely (at home) and independently three times per week for 30 minutes using an online software called NeuroNation and will target executive function, verbal learning and memory and complex attention domains, which are affected in young stroke survivors. Re-timer glasses will be used to deliver green-blue light therapy (500nm, 230 µW/cm2, 506 lux) for 30 minutes each morning at participants homes for the duration of the trial and will be supplemented by illustrative sleep health guidelines promoting greater sleep hygiene, including but not limited to, reduced screen time, relaxation techniques and food consumptions before bed (developed for an existing trial, see ACTRN12621000773831). Green-blue light therapy has been shown to positively impact fatigue, which contributes to cognitive impairments. Healthy eating guidance will be delivered as written and illustrative resources and will align with the MIND diet (e.g., focus on consuming green leafy vegetables, berries, nuts, olive oil, fish etc). The resources have been specifically designed for this study. Participants will be asked to read through the provided healthy eating resources. The extent to which participants re-read resources is at their discretion.

Twelve 30-minute coaching sessions (one per week for the duration of the intervention) will be provided by a study researcher (exercise physiologist or occupational therapist) to participants via Microsoft Teams to facilitate adherence and compliance to the environmental enrichment program. Consistent with inpatient studies, participants will be provided with a variety of resources to enrich their environments, such as puzzles, games and books on healthy living. These resources will align with the interests of individuals.
Intervention code [1] 322890 0
Lifestyle
Intervention code [2] 323275 0
Rehabilitation
Intervention code [3] 323276 0
Treatment: Devices
Comparator / control treatment
The lifestyle guidance program will serve as a comparator intervention and will be delivered by research staff (exercise physiologist or occupational therapist). Participants will receive a lifestyle guidance booklet designed specifically for this study and 12 30-minute coaching sessions on the benefits of physical activity, cognitive stimulation, health eating and sleep. Participants in the lifestyle guidance group will be given access to the details of the environmental enrichment program following the completion of the trial (e.g., after the completion of the follow-up assessment point [24 weeks post-enrolment]).
Control group
Active

Outcomes
Primary outcome [1] 330548 0
Feasibility will be evaluated according to recommendations outlined by Learmonth & Motl (2018), with process, resource, management and scientific metrics examined via an audit of study records retained in the study database.

Process: Evaluation of the process metric will involve an audit of participant recruitment and retention data (number referred, number eligible, number enrolled, number of withdrawals, trial recruitment rate, trial completion rate).

Resource: Evaluation of the resource metric will involve an audit of communication with participants and staff (the method and time spent communicating with staff and participants will be recorded), as well as all monetary costs involved with execution of the research.

Management: Evaluation of the management metric will involve an audit of research ethics and governance approval procedures, staff preparation time for participant communication, time and accuracy in data collection/entry and the reporting and handling of adverse events (AEs; musculoskeletal injury), serious adverse events (SAEs; serious falls) and clinical emergencies (cardiovascular events).

Scientific: Evaluation of the scientific metric will involve an audit of AEs, SAEs and clinical emergencies. In addition, it will involve an audit of participant experiences, burden, adherence and compliance to interventions (via an intervention diary and weekly telehealth chats). Participant experiences will be captured with a semi-structured interview and will probe barriers and motivators to engagement and perceived positive and negatives about interventions.

Feasibility metrics are considered a composite outcome.
Timepoint [1] 330548 0
Feasibility will be measured throughout the entirety of the trial in accordance with Learmonth and Motl (2018) recommendations.
Secondary outcome [1] 406619 0
Verbal learning and memory will be evaluated using the Hopkins Verbal Learning Test-Revised.
Timepoint [1] 406619 0
Verbal learning and memory will be evaluated using the Hopkins Verbal Learning Test- Revised at baseline (week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [2] 406623 0
Language will be evaluated using the Controlled Oral Word Association Test.
Timepoint [2] 406623 0
Language will be evaluated using the Controlled Oral Word Association Test at baseline (week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [3] 406624 0
Working memory will be evaluated using the Digit Span Test.
Timepoint [3] 406624 0
Working memory will be evaluated using the Digit Span Test at baseline (week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [4] 406627 0
Self reported cognitive impairment will be evaluated using the Cognitive Failures Questionnaire.
Timepoint [4] 406627 0
Self reported cognitive impairment will be evaluated using the Cognitive Failures Questionnaire at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [5] 406629 0
Activities of daily living will be evaluated using the Nottingham Extended Activities of Daily Living Questionnaire.
Timepoint [5] 406629 0
Activities of daily living will be evaluated using the Nottingham Extended Activities of Daily Living Questionnaire at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [6] 406630 0
Quality of life will be evaluated using the Stroke Specific Quality of Life-Scale 12.
Timepoint [6] 406630 0
Quality of life will be evaluated using the Stroke Specific Quality of Life-Scale 12 at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [7] 406631 0
Fatigue severitywill be evaluated using the Fatigue Severity Scale.
Timepoint [7] 406631 0
Fatigue severity will be evaluated using the Fatigue Severity Scale at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [8] 406633 0
Social Network will be evaluated using the Social Network Index.
Timepoint [8] 406633 0
Social network will be evaluated using the Social Network Index at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [9] 406634 0
Depression, Anxiety and Stress will be evaluated using the Depression Anxiety Stress Scale -21.
Timepoint [9] 406634 0
Depression, Anxiety and Stress will be evaluated using the Depression, Anxiety, Stress Scale at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [10] 406635 0
Sleep quality will be evaluated using wrist-worn actigraphy.
Timepoint [10] 406635 0
Sleep quality will be evaluated using wrist worn actigraphy at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [11] 406636 0
Exploration of genetic markers will be evaluated using collected saliva samples.
Timepoint [11] 406636 0
Genetic markers will be explored using collected saliva samples. Saliva samples will be collected at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [12] 406645 0
Emotional wellbeing will be evaluated using the Brief Emotional Experience Scale.
Timepoint [12] 406645 0
Emotional wellbeing will be evaluated using the Brief Emotional Experience Scale at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [13] 408287 0
Temporal changes in cognition will be evaluated using the following question (administered via diary or REDCap):

"Right now, my thinking is slow".

Answers will be rated on a scale from 1 (not at all) to 5 (very much).
Timepoint [13] 408287 0
Temporal changes in cognition will be measured three times a day over a seven-day period at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [14] 408289 0
Temporal changes in fatigue will be evaluated using the following question (administered via diary or REDCap):

"Mentally, I feel exhausted now" and "Physically, I feel exhausted now".

Answers will be rated on a scale from 1 (not at all) to 5 (very much). This will be assessed as a composite outcome.
Timepoint [14] 408289 0
Temporal changes in fatigue will be measured three times a day over a seven-day period at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [15] 408290 0
Temporal changes in mood will be evaluated using the following question (administered via diary or REDCap):

"Right now, I feel depressed.".

Answers will be rated on a scale from 1 (not at all) to 5 (very much).
Timepoint [15] 408290 0
Temporal changes in mood state will be measured three times a day over a seven-day period at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [16] 413791 0
International Physical Activity Questionnaire-Short
Timepoint [16] 413791 0
Physical activity level will be evaluated using the International Physical Activity Questionnaire-Short at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [17] 413792 0
The progressive subtraction task will be used to assess dual tasking.
Timepoint [17] 413792 0
Dual tasking will be evaluated using the International Physical Activity Questionnaire-Short at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [18] 415420 0
Consensus Sleep Diary

The consensus sleep diary will be used to evaluated sleep-wake behaviour.
Timepoint [18] 415420 0
The consensus sleep diary will be used to evaluated sleep-wake behaviour at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [19] 415421 0
Sleep quality

Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index.
Timepoint [19] 415421 0
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [20] 415422 0
Daytime sleepiness

Daytime sleepiness will be evalauted using the Epworth Sleepiness Scale.
Timepoint [20] 415422 0
Daytime sleepiness will be evalauted using the Epworth Sleepiness Scale at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).
Secondary outcome [21] 415423 0
Cognitive Reserve

Cognitive reserve will be evaluated using the cognitive reserve index.
Timepoint [21] 415423 0
Cognitive reserve will be evaluated using the Cognitive Reserve Index at baseline (Week 0), after the intervention period (12 weeks) and following a washout period (24 weeks).

Eligibility
Key inclusion criteria
Inclusion criteria for this trial are as follows:
1) young stroke survivors aged 18-65 ;
2) radiologically confirmed diagnosis of ischaemic/haemorrhagic stroke and > 3 months post-stroke;
3) a modified Rankin score < 4 (Modified Rankin Assessment);
4) Tele-Montreal Cognitive Assessment score of 17 or more
5) clearance from a medical practitioner to participate
6) the ability to follow verbal and written instructions; and
7) the ability to provide informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are as follows:
1) history of neurological conditions other than stroke;
2) an untreated mental illness;
3) active substance abuse;
4) severe aphasia preventing cognitive examinations;
5) cardiovascular conditions that contraindicate exercise (medical clearance requested);

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)
Participants will be randomly allocated to intervention groups by an independent biostatistician. Study assessors will be blinded to group allocation. Research staff responsible for administering the interventions will not be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using simple block randomisation using a table created by computer software (i.e. computerised sequence generation). Sequences will be generated using stroke severity (modified Rankin score).
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
Safety/efficacy
Statistical methods / analysis
A-priori sample size calculation was performed using G*Power version 3.1 based on the Stroop Test performance results by Kim et al whereby a 25% increase in the average score (Pre 40.7 ± 15.7, Post 51.0 ± 15.9) was observed post intervention for the dual-task training, which was maintained at follow-up (52.1 ± 16.7). This increase represents a moderately large effect size (Cohen’s d > 0.65) at both post-intervention and follow-up. In contrast for the single-task training group, there were minimal changes in Stroop Test performance from baseline (32.5 ± 14.3) to post-intervention (33.1 ± 13.1), and later at follow up (34.2 ± 14.8). Hence for our proposed study, a minimum sample size of 28 is required for a repeated-measures design with two groups (EE vs control) with three time-points (baseline, 12 weeks and 24 weeks) to detect at least a medium Group × Time interaction effect (Cohen’s f = 0.25) at the 5% level of significance with 80% power. Assuming an attrition rate of 20%, the final minimum required sample is 36 (or 18 per group). For the primary outcome, rates of recruitment (numbers consented/eligible), completion (undertaken baseline and follow-up tests), adherence (participant completed sessions/number of sessions), compliance (volume completed/prescribed volume), program tolerance (sessional rating of perceived exertion [RPE] by the patient using the Borg 0-10 scale after every exercise session) and adverse events (number and number per participant hour) will be calculated. The effects of the EE program on secondary and tertiary outcomes at 12 and 24 weeks will be evaluated using a repeated-measures mixed-model ANOVA. Separate models comparing the EE group to the LG group will include main effects for Group and Time and a Group × Time interaction term. Each outcome measure will be tested separately. Analyses will be intention-to-treat. Multiple imputation will be used for missing data. Models will include age, sex and disability status as covariates. Statistical significance will be set at an alpha level of 0.05. False discovery rate (FDR) corrections will be applied to all analysed outcomes to account for multiple testings. Effects sizes in the form of Cohen’s d will be calculated and interpreted based on the following criteria: d = 0.2 small; d = 0.5 moderate; d = 0.8 large.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/01/2023
Actual
31/03/2023
Date of last participant enrolment
Anticipated
29/03/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
36
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310810 0
Other Collaborative groups
Name [1] 310810 0
Neurotrauma Research Program
Country [1] 310810 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 312055 0
None
Name [1] 312055 0
Address [1] 312055 0
Country [1] 312055 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310378 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 310378 0
Ethics committee country [1] 310378 0
Australia
Date submitted for ethics approval [1] 310378 0
31/08/2021
Approval date [1] 310378 0
02/03/2022
Ethics approval number [1] 310378 0

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

Contacts
Principal investigator
Name 117442 0
Dr Travis Cruickshank
Address 117442 0
Edith Cowan University
270 Joondalup Drive, Joondalup, 6027, Perth, Western Australia
Country 117442 0
Australia
Phone 117442 0
+61 8 6304 3416
Fax 117442 0
Email 117442 0
t.cruickshank@ecu.edu.au
Contact person for public queries
Name 117443 0
Travis Cruickshank
Address 117443 0
Edith Cowan University
270 Joondalup Drive, Joondalup, 6027, Perth, Western Australia
Country 117443 0
Australia
Phone 117443 0
+61 8 6304 3416
Fax 117443 0
Email 117443 0
t.cruickshank@ecu.edu.au
Contact person for scientific queries
Name 117444 0
Travis Cruickshank
Address 117444 0
Edith Cowan University
270 Joondalup Drive, Joondalup, 6027, Perth, Western Australia
Country 117444 0
Australia
Phone 117444 0
+61 8 6304 3416
Fax 117444 0
Email 117444 0
t.cruickshank@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data may be shared upon reasonable request following completion of the study and publishing of findings.
When will data be available (start and end dates)?
Data may be available beginning three months and ending five years following the main results publication.
Available to whom?
Researchers will need to submit an expression of interest to study investigators to access the data. If the proposal is deemed methodologically sound, access to the data will be granted.
Available for what types of analyses?
Data will be made available for the type of analysis outlined in the expression of interest/proposal document that is submitted to study investigators.
How or where can data be obtained?
Access to data will be subject to approval by the research team. Once approved, data will be shared via email correspondence with a member of the research team (please contact the Chief Investigator, Dr Travis Cruickshank, on t.cruickshank@ecu.edu.au for further information).


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.