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Trial registered on ANZCTR


Registration number
ACTRN12623001099617
Ethics application status
Approved
Date submitted
25/09/2023
Date registered
20/10/2023
Date last updated
20/10/2023
Date data sharing statement initially provided
20/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise as a non-pharmacological intervention for the management of sleep disturbance in adults with primary brain tumours and their caregivers
Scientific title
Exercise as a non-pharmacological intervention for the management of sleep disturbance in adults with primary brain tumours and their caregivers
Secondary ID [1] 310505 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Brain Tumours 331305 0
Sleep disturbance 331306 0
Condition category
Condition code
Cancer 328065 328065 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study comprises a self-controlled, 14-week longitudinal study comprising a 4-week period during which participants will undertake usual activities while having their sleep monitored and 8-weeks of individualised, home-based exercise delivered via telehealth. A longitudinal study design allows for tracking of participants sleep measures over a longer period of time, with continual monitoring performed by the Oura ring for objective sleep measures, as well as 3 study time points (baseline, mid-way, post-intervention) where subjective questionnaires will be completed. Furthermore, a longitudinal study design address the following points:
1. It can capture changes in sleep quality and architecture over time as opposed to one time point;
2. It can account for an individual’s variability in sleep – sleep disturbance can have different causes and symptoms in different people. By following the group for a longer period of time, it allows the research team to account for these individual differences in sleep disturbance;
3. It can examine potential mediators and moderators that may influence the effectiveness of exercise on sleep disturbance (e.g., age, sex, anthropometric measures, severity of sleep disturbance, pre-intervention exercise levels).
A self-controlled study design is ethically appropriate as it would remove the necessity for a control group that would not be given an exercise intervention that may elicit clinically significant improvements (e.g., improved sleep, enhanced QoL).

All participants, both caregivers and PBT survivors, will be required to attend 2x telehealth sessions per week, which will be timetabled prior to commencing the exercise intervention in consultation with participants at a mutually agreeable time. Sessions will be with individual groups; if both a PBT survivor and their caregiver are recruited at the same time, the sessions will be conducted at the same time. However, if there is only one participant, then it will be an individual session. Another example is two PBT survivors/caregivers recruited separately will not have sessions together. All sessions will be supervised by an Accredited Exercise Physiologist (AEP). Each session will go for approximately 1 hour adhereing to the following format:
- 10 minute subjective consultation/check in;
- 5-10 minute warm-up/flexibility/aerobic;
- 30-45 minutes of resistance exercise (e.g., seated rows, crab walks, shoulder press, chest press, side lying clams, crab walks, squats/glute bridges w/ band around knees, kettlebell swings).

Participants will also be encouraged to perform 30-minutes aerobic activity on at least 2 other days of the week, individualised by RPE prescription and modality – some participants may be more capable of performing a different modality (e.g., walking vs. running vs. bike vs. swimming).

Session intensities will be moderate, assessed with by the Borg RPE scale (6-20). Exercise session adherence will be tracked using an exercise diary for participants to complete, as well as session attendance checklists completed by supervising AEP.

Participants will be provided with an equipment pack containing the necessary pieces of equipment to perform the intervention, including:
- Resistance bands (Handle) of varying tension (e.g., easy, medium, hard, very hard)
- Fabric “booty” bands of varying tension (e.g., easy, medium, hard)
- 28kg Kettlebell set (1x 4kg, 6kg, 8kg, 10kg)
- Exercise/yoga mat.
Pieces of furniture (e.g., chairs, benches, tables, steps, etc.) will also be utilised to complete these sessions where necessary.


The study duration is 14-weeks in total if allocated an Oura Ring, otherwise it is 10-weeks total. Not all participants of the study will be given an Oura Ring; rather, alternation will be used - rings will be provided to every second participant we recruit without allocating specific numbers to them.
This includes:
- A 4-week ring calibration period if allocated an Oura Ring (weeks -4 to -1) where participants will perform usual activities - the only time where participants NEED to wear the ring is at night for accurate sleep tracking, though they will be encouraged to wear the ring at all times unless charging;
- Baseline testing performed (week 0);
- 8-weeks of individualised exercise (weeks 1 - 8) - participants allocated an Oura Ring will be required to continue to wear the ring for the entirety of the exercise intervention;
- Post-intervention testing performed at the end of the 8-weeks of individualised exercise (week 9).
Intervention code [1] 326900 0
Rehabilitation
Intervention code [2] 326901 0
Lifestyle
Intervention code [3] 327083 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336170 0
Sleep Quality recorded using the Pittsburgh Sleep Quality Index
Timepoint [1] 336170 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Primary outcome [2] 336276 0
Insomnia using the Insomnia Severity Index
Timepoint [2] 336276 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Primary outcome [3] 336277 0
Participant qualitative sleep experience reported through a sleep diary and semi-structured qualitative interviews combined as a composite qualitative outcome measure
Timepoint [3] 336277 0
Semi-structured Interviews performed at Baseline (week 0) and post-intervention evaluation (week 9); sleep diary recorded throughout entireity of intervention.
Secondary outcome [1] 427194 0
Cardiovascular fitness recording using the 6-Minute Walk Test
Timepoint [1] 427194 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Secondary outcome [2] 427197 0
Objective sleep measures recorded by the Oura Ring
Timepoint [2] 427197 0
Continuous throughout the exercise intevention (Week 0-9)
Secondary outcome [3] 427198 0
Upper body muscular strength assessed by performing 5 repetition max testing for chest press
Timepoint [3] 427198 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Secondary outcome [4] 427199 0
Dynamic balance assessed using the Timed Up and Go test
Timepoint [4] 427199 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Secondary outcome [5] 427200 0
Quality of Life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 (General)
Timepoint [5] 427200 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Secondary outcome [6] 427201 0
Mental Health assessed using the Depression, Anxiety, Stress Scale (DASS-21) - composite score as the DASS-21 is a single questionnaire.
Timepoint [6] 427201 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Secondary outcome [7] 427641 0
Lower body muscular strength assessed using leg pres 5Repetition Max assessment
Timepoint [7] 427641 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Secondary outcome [8] 427642 0
Static balanced assessed using the Romberg Balance protocol.
Timepoint [8] 427642 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Secondary outcome [9] 427643 0
PBT Survivor quality of life assessed using the EORTC BN20 (Brain Tumour) Module
Timepoint [9] 427643 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Secondary outcome [10] 427644 0
Caregiver quality of life assessed using the Caregiver Quality of Life – Cancer Questionnaire (CQOLC) (caregivers).
Timepoint [10] 427644 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Secondary outcome [11] 427645 0
Anthropometric Measure - Height using a stadiometer.
Timepoint [11] 427645 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Secondary outcome [12] 427646 0
Anthropometric Measure - Weight measured using a digital scale.
Timepoint [12] 427646 0
Baseline (week 0), Post-intervention evaluation (Week 9)
Secondary outcome [13] 427647 0
Anthropometric Measure - BMI calculated using the results of the height and weight measures for each individual participant.
Timepoint [13] 427647 0
Baseline (week 0), Post-intervention evaluation (Week 9)

Eligibility
Key inclusion criteria
PBT survivors:
1. Diagnosis of a histologically confirmed primary brain tumour, WHO Grades II-IV;
2. Have completed all planned initial therapies (e.g., surgery, radiation therapy etc.) at least 8 weeks prior to recruitment;
3. The ability to perform aerobic and resistance training exercise as determined by oncologist/treating physician;
4. Able to receive medical clearance and approval based on medical and psychological factors to participate in the study by their oncologist/treating physician;
5. Being able to give written consent and undertake the study measures in English;
6. 18 years of age or over.
Caregivers:
For the purpose of this study's inclusion/exclusion criteria, caregivers include individuals who are relatives or close companions providing care and support to PBT survivors. This includes spouses, partners, adult children, siblings, or other family members who assume caregiving responsibilities such as assisting with activities of daily living, medication management, emotional support, and coordinating healthcare services for the PBT survivor. Caregivers who are employed as a part through an external service/care provider are ineligible for inclusion.
Furthermore, caregivers need to:
1. Identify as the primary caregiver of an eligible brain cancer survivor;
2. Being able to give written consent and undertake the study measures independently in English;
3. 18 years of age or over.
Furthermore, all participants will need to:
1. Be able to attend pre- and post-intervention exercise testing at QUT Health Clinics, Kelvin Grove;
2. Have access to a computer/laptop/tablet/phone with a forward-facing camera and microphone to participate;
3. Have a smartphone with Bluetooth connectivity if allocated an Oura Ring – participants who are allocated an Oura Ring will need to download the Oura Ring app for data collection;
4. Have internet connection to support telehealth component of the intervention;
5. Have an appropriate space at home to set up computer/laptop/tablet/phone and perform exercise.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. PBT survivors with ECOG status greater than or equal to 2
2. Any of the following medical concerns:
a. Significant or active cardiovascular condition (i.e., recent myocardial infarction; uncontrolled or symptomatic unstable angina or claudication, heart failure, cardiomyopathy, coronary stenosis, arrhythmia);
b. Severe aortic stenosis;
c. Uncontrolled hypertension (HTN) (i.e. Systole > 160 and Diastole > 90 mm Hg);
d. Poorly controlled diabetes;
e. Recent pulmonary embolus;
f. Dyspnoea at rest or with minimal activity;
g. Recent major surgery;
h. Acute infection, fever, or feeling unwell (not limited to but including acute myocarditis / pericarditis);
i. Resting tachycardia +/- arrhythmias;
j. Change in clinical status (e.g. symptoms occurring at lower levels of exertion or at rest).
3. Pregnant women
4. Children and adolescents (less than 18 years of age)
5. Have an inability to communicate in written and spoken English;
6. Have cognitive impairment that results in the inability to provide informed consent to participate and carry out the demands of the proposed project;
7. Currently participating in another exercise intervention study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2023
Actual
Date of last participant enrolment
Anticipated
1/11/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25577 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 41399 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 314897 0
University
Name [1] 314897 0
Queensland University of Technology
Country [1] 314897 0
Australia
Funding source category [2] 314979 0
Hospital
Name [2] 314979 0
Princess Alexandra Hospital
Country [2] 314979 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
149 Victoria Park Rd, Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 316900 0
None
Name [1] 316900 0
Address [1] 316900 0
Country [1] 316900 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313706 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 313706 0
Metro South Research Level 7, Translational Research Institute 37 Kent Street Woolloongabba QLD 4102
Ethics committee country [1] 313706 0
Australia
Date submitted for ethics approval [1] 313706 0
02/05/2023
Approval date [1] 313706 0
14/07/2023
Ethics approval number [1] 313706 0

Summary
Brief summary
This study aims to explore the use of exercise as an intervention to assist with the management of sleep disturbance in primary brain tumour survivors and their caregivers

Who is it for?
You may be eligible to join this study if you are aged 18 years and older and have histologically confirmed primary brain tumour (WHO Grades II-IV)

Study details
All participants in this study will have 2x telehealth sessions per week with an Accredited Exercise Physiologist who will prescribe each participant an individualised exercise program to conducted over an 8-week period. While the exercise sessions will be individualised, the general exercise prescription (e.g., frequency, intensity, time, type) will be consistent across all participants. Participants will also be prescribed individualised aerobic exercise program 2x per week on days that they are not performing their telehealth session.

Participants may also be allocated an Oura Ring to wear throughout the study period as well as a 4 week calibration/baseline period prior to commencing the 8-week intervention period to objectively monitor sleep. Participants will be allocated an Oura Ring through an alternating system (i.e., every second participant recruited will be allocated a ring to wear) which will be provided to participants prior to their baseline testing session.

Participants will also complete questionnaires to assess sleep quality, quality of life and mental health and functional outcomes will also be assessed before and after the intervention period. Semi-structured qualitative interviews will also be conducted pre- and post-intervention exploring each participants sleep experiences and their beliefs on what contributes to said experiences.

It is hoped that this research project will contribute to the understanding of exercise's potential role in managing sleep disturbances for PBT survivors and their caregivers. By addressing the gaps in existing literature and collecting comprehensive data on sleep, quality of life, functional, and mental health outcomes, this study aspires to provide evidence-based recommendations for improving the well-being of individuals affected by primary brain tumors
Trial website
Trial related presentations / publications
Public notes
BRAINS EMCR Showcase - https://www.youtube.com/watch?v=m8lSdN6kKrg

Martin JA, Hart NH, Bradford N, Naumann F, Pinkham MB, Pinkham EP, Holland JJ. Prevalence and management of sleep disturbance in adults with primary brain tumours and their caregivers: a systematic review. Journal of Neuro-Oncology. 2023 Mar 2:1-20.

Contacts
Principal investigator
Name 129078 0
Mr Jason Martin
Address 129078 0
Queensland University of Technology, 149 Victoria Park Rd, Kelvin Grove QLD 4059
Country 129078 0
Australia
Phone 129078 0
+61 404510423
Fax 129078 0
Email 129078 0
martij23@qut.edu.au
Contact person for public queries
Name 129079 0
Mr Jason Martin
Address 129079 0
Queensland University of Technology, 149 Victoria Park Rd, Kelvin Grove QLD 4059
Country 129079 0
Australia
Phone 129079 0
+61 404510423
Fax 129079 0
Email 129079 0
martij23@qut.edu.au
Contact person for scientific queries
Name 129080 0
Mr Jason Martin
Address 129080 0
Queensland University of Technology, 149 Victoria Park Rd, Kelvin Grove QLD 4059
Country 129080 0
Australia
Phone 129080 0
+61 404510423
Fax 129080 0
Email 129080 0
martij23@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.