Exercise as a non-pharmacological intervention for the management of sleep disturbance in primary brain tumour survivors and their caregivers: A study protocol of a clinical trial

Jason A. Martin , Nicolas H. Hart , Natalie Bradford , Fiona Naumann , Mark B. Pinkham , Elizabeth P. Pinkham , Justin J. Holland
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Abstract

Background

Sleep disturbance is a highly prevalent and impactful symptom experienced by those adversely affected by primary brain tumours. Despite this, there is a lack of literature exploring appropriate options for the management of sleep disturbance in these populations. As such, more holistic and patient-centred approaches to address sleep disturbance are needed. Exercise presents itself as a viable option for managing sleep disturbances given its numerous health benefits, minimal costs, and acceptability, though the feasibility of its use in the context of primary brain tumours is unknown.

Methods

Primary brain tumour survivors and their caregivers will enrol and participate in a supervised, eight-week exercise intervention delivered by telehealth. Feasibility will be assessed using predetermined study metrics, including eligibility, recruitment. and assessment completion rates. Acceptability will be assessed using retention to intervention rates, session attendance, and participant satisfaction. Sleep will be assessed both objectively, using ring sleep trackers, and subjectively, using questionnaires.

Conclusion

This study will be the first to explore the feasibility and acceptability of exercise for the management of sleep disturbance in primary brain tumour survivors and their caregivers. If successful, this protocol will contribute to the development and implementation of appropriate strategies to manage sleep disturbance in these populations.

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运动作为一种非药物干预措施,用于治疗原发性脑肿瘤幸存者及其护理人员的睡眠障碍:临床试验研究方案
背景睡眠障碍是原发性脑肿瘤患者普遍存在且影响较大的症状。尽管如此,目前仍缺乏文献探讨治疗这些人群睡眠障碍的适当方案。因此,需要更全面的、以患者为中心的方法来解决睡眠障碍问题。鉴于运动对健康的诸多益处、最低的成本和可接受性,它本身就是一种管理睡眠障碍的可行方案,但其在原发性脑肿瘤中使用的可行性尚不清楚。方法原发性脑肿瘤幸存者及其护理人员将报名并参加通过远程医疗提供的为期八周的监督运动干预。可行性将通过预先确定的研究指标进行评估,包括资格审查率、招募率和评估完成率。可接受性将通过干预保留率、疗程出勤率和参与者满意度进行评估。将使用环形睡眠追踪器对睡眠情况进行客观评估,并使用调查问卷对睡眠情况进行主观评估。 结论:本研究将首次探讨运动治疗原发性脑肿瘤幸存者及其护理人员睡眠障碍的可行性和可接受性。如果研究成功,该方案将有助于制定和实施适当的策略来管理这些人群的睡眠障碍。
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