RecruitingACTRN12623001099617

Exercise as a non-pharmacological intervention for the management of sleep disturbance in adults with primary brain tumours and their caregivers


Sponsor

Queensland University of Technology

Enrollment

15 participants

Start Date

Aug 8, 2024

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Sleep problems are extremely common among people living with a brain tumour and their family caregivers — the worry, fatigue, and treatment side effects can make restful sleep feel impossible. Exercise is known to improve sleep in many other populations, but it hasn't been studied specifically in this group. This study is testing whether a personalised, online exercise program can help improve sleep quality for both brain tumour survivors and the people who care for them. Participants work with a qualified exercise physiologist via video sessions twice a week for eight weeks, plus additional independent aerobic exercise sessions. Some participants will also wear an Oura Ring (a smart ring) to objectively track their sleep throughout the study. Questionnaires will assess sleep, mental health, and quality of life before and after. You may be eligible if you are aged 18 or older and have a confirmed Grade II–IV primary brain tumour and have completed your initial cancer treatment at least 8 weeks ago. Caregivers of eligible brain tumour survivors are also invited to join. You will need internet access, a device with a camera, and space at home to exercise. People with serious heart conditions or who are currently in another exercise trial are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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 o

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).


Locations(1)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12623001099617