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

Not Applicable

• Conditions: Primary Brain Tumours; Sleep disturbance; Cancer - Brain

• Registration Number: ACTRN12623001099617
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-20
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 25

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep Quality recorded using the Pittsburgh Sleep Quality Index [ Baseline (week 0), Post-intervention evaluation (Week 9)];Insomnia using the Insomnia Severity Index[ Baseline (week 0), Post-intervention evaluation (Week 9)];Participant qualitative sleep experience reported through a sleep diary and semi-structured qualitative interviews combined as a composite qualitative outcome measure[ Semi-structured Interviews performed at Baseline (week 0) and post-intervention evaluation (week 9); sleep diary recorded throughout entireity of intervention. ]