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Clinical Trials/ACTRN12623001099617
ACTRN12623001099617
Not yet recruiting
未知

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

Queensland University of Technology0 sites25 target enrollmentOctober 20, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Primary Brain Tumours
Sponsor
Queensland University of Technology
Enrollment
25
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 20, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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:

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);

Outcomes

Primary Outcomes

Not specified

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