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临床试验/NCT05859204
NCT05859204Enrolling By Invitation不适用

Impact of Exercise Groups on Patient Mental Health and Wellbeing in an Acute Psychiatric Inpatient Unit

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
60
试验地点
2
主要终点
Change in depression using Patient Health Questionnaire-9

研究概览

简要总结

More research is needed to elucidate the impacts of physical activity interventions on short- and long-term activity and neuropsychiatric symptoms (NPS) in psychiatric inpatients and to support its advantageousness when compared to current standards of care. To investigate the impact of regular exercise on activity level, NPS, and sleep in an inpatient psychiatry unit, the investigators propose a placebo-controlled study with measures of activity, mood, anxiety, energy, and sleep as primary outcomes in 50 psychiatric inpatients at Johns Hopkins Hospital. Given the challenges of maintaining blinded assignment to treatment arm, the investigators will compare patients during two time periods (3 months each): the first is treatment as usual (TAU), the second adds exercise intervention (EXI).

详细描述

Growing evidence suggests that physical activity is associated with increased cognitive functioning and improved mental health. A recent meta-analysis demonstrated an inverse, dose-response association between physical activity and depression, particularly at lower activity volumes. Similarly, exercise has been shown to be associated with decreased anxiety, improved sleep, and reduced cognitive deficits in outpatient settings.

Despite the beneficial impacts of regular physical activity on mental health, physical activity is often low in psychiatric inpatient settings. Common barriers to exercise include lack of time and resources, limited staff knowledge, and competing treatment priorities. Organizational policy such as strict security procedures and restricted patient movement may also limit consistent integration of exercise into care. Finally, individuals with severe mental illness more commonly have sedentary lifestyles and may experience sedative side-effects of medication, which further limit ability to engage in physical activity.

There is limited literature on the impact of interventions aimed at increasing physical activity in psychiatric inpatient settings, however preliminary research suggests that these interventions may have positive short-term impacts on patients' mood and self-esteem. Investigators have found that over 90% of inpatients noted improved mood and body perception immediately following a structured exercise program. Moreover, there is evidence that psychiatric inpatients have a positive viewpoint of psychical activity intervention as part of psychiatric treatment and believe it will benefit the patients health. Given these findings, more research is needed to elucidate the impacts of physical activity interventions on short- and long-term activity and neuropsychiatric symptoms (NPS) in psychiatric inpatients and to support its advantages when compared to current standards of care.

Thus, to investigate the impact of regular exercise on activity level, NPS, and sleep in an inpatient psychiatry unit, the investigators propose a placebo-controlled study with measures of activity, mood, anxiety, energy, and sleep as primary outcomes in 60 psychiatric inpatients at Johns Hopkins Hospital. Half of the participants will be assigned to the exercise intervention (EXI) group, and the other half will be assigned to the treatment as usual (TAU) group. Group assignment will be made based on timing of study enrollment - the first 30 participants will be assigned to the TAU group, while the subsequent 30 participants will be assigned to the EXI group. Activity will be measured via actigraphy and self-report.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Psychiatric inpatients admitted to the Johns Hopkins Bayview Acute Psychiatric Unit (APU)
  • Aged 18 years or older
  • Able to give informed consent and understand the tasks involved
  • In the opinion of the unit attending, the patient is sufficiently psychologically or medically stable to safely participate in the exercise intervention
  • Patients using mobility devices such as canes, walkers, and wheelchairs are eligible for inclusion as exercises can be completed in modifiable positions as needed.

排除标准

  • Patients who do not speak English as their primary language.
  • Patients with a history of physical or neurological conditions that interfere with study procedures.
  • Patients demonstrating behavior that would be a safety concern if placed in a group at the discretion of occupational therapy, the medical team, or the nursing team.
  • A patient can be excluded if in the opinion of the treatment team on the unit, participation in the study would have a negative impact on the patient's mental health or treatment plan.

研究组 & 干预措施

OT-led Exercise Group on Inpatient Psychiatry Unit

Experimental

Occupational therapist (OT) led group. Group includes education, warm-up, high intensity interval training cardio, strength, kick boxing, cool-down, yoga, and discussion. This group also receives the Treatment as Usual groups.

干预措施: OT-led Exercise Group (Behavioral)

Treatment As Usual - OT Groups on Inpatient Psychiatry Unit

Placebo Comparator

An occupational therapist (OT) will begin daily educational session about the topic of choice for that day.

干预措施: Treatment as Usual - OT Groups (Behavioral)

结局指标

主要结局

Change in depression using Patient Health Questionnaire-9

时间窗: baseline, time of discharge up to 6 months

Patient Health Questionnaire-9, range 0-27, lower score better outcome

Change in anxiety using Generalized Anxiety Disorder-7

时间窗: baseline, time of discharge up to 6 months

Generalized Anxiety Disorder-7, range 0-21, lower score better outcome

Change in sleep using Pittsburgh Sleep Quality Index

时间窗: baseline, time of discharge up to 6 months

Pittsburgh Sleep Quality Index, range 0-21, lower score better outcome

次要结局

  • Length of Stay(time of discharge up to 6 months)

研究者

发起方
Johns Hopkins University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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