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

Primary Purpose

Psychiatric Hospitalization, Physical Inactivity, Depression, Anxiety

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OT-led Exercise Group
Treatment as Usual - OT Groups
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychiatric Hospitalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OT-led Exercise Group on Inpatient Psychiatry Unit

Treatment As Usual - OT Groups on Inpatient Psychiatry Unit

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in depression using Patient Health Questionnaire-9
Patient Health Questionnaire-9, range 0-27, lower score better outcome
Change in anxiety using Generalized Anxiety Disorder-7
Generalized Anxiety Disorder-7, range 0-21, lower score better outcome
Change in sleep using Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index, range 0-21, lower score better outcome

Secondary Outcome Measures

Length of Stay
Length of stay will be collected via retrospective patient chart review or from patient care team upon discharge

Full Information

First Posted
May 4, 2023
Last Updated
August 7, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05859204
Brief Title
Impact of Exercise Groups on Patient Mental Health and Wellbeing in an Acute Psychiatric Inpatient Unit
Official Title
Impact of Exercise Groups on Patient Mental Health and Wellbeing in an Acute Psychiatric Inpatient Unit
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Hospitalization, Physical Inactivity, Depression, Anxiety, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OT-led Exercise Group on Inpatient Psychiatry Unit
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual - OT Groups on Inpatient Psychiatry Unit
Arm Type
Placebo Comparator
Arm Description
An occupational therapist (OT) will begin daily educational session about the topic of choice for that day.
Intervention Type
Behavioral
Intervention Name(s)
OT-led Exercise Group
Intervention Description
Participants will complete pre-intervention self-report surveys about mood, anxiety, energy, self-esteem, and activity handed out by the research team. At this point, an occupational therapist (OT) will begin 10-minute educational session that describes the purpose of the exercise intervention and methods to remain safe during the intervention such as self-monitoring techniques. Following completion of the educational session, participants will complete a 30-minute exercise intervention under the guidance of the OT, which includes warm-up, high intensity interval training cardio, strength, kick boxing, cool-down, and yoga. Following completion of the exercise regimen, participants will participate in a 10-minute discussion and reflection with the OT and complete post-intervention self-report surveys. Participants in the intervention arm will also receive routine daily occupational therapy educational sessions received by the treatment as usual arm.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual - OT Groups
Intervention Description
Participants will complete pre-session self-report surveys about mood, anxiety, energy, self-esteem, and activity handed out by the research team. At this point, an occupational therapist (OT) will begin daily educational session about the topic of choice for that day. Treatment groups are largely discussion-based and include the following topics: coping skills, self-esteem, sleep management, leisure, time management, life skills, decision making, and goal setting. Following completion of the educational session, participants will complete post-intervention self-report surveys.
Primary Outcome Measure Information:
Title
Change in depression using Patient Health Questionnaire-9
Description
Patient Health Questionnaire-9, range 0-27, lower score better outcome
Time Frame
baseline, time of discharge up to 6 months
Title
Change in anxiety using Generalized Anxiety Disorder-7
Description
Generalized Anxiety Disorder-7, range 0-21, lower score better outcome
Time Frame
baseline, time of discharge up to 6 months
Title
Change in sleep using Pittsburgh Sleep Quality Index
Description
Pittsburgh Sleep Quality Index, range 0-21, lower score better outcome
Time Frame
baseline, time of discharge up to 6 months
Secondary Outcome Measure Information:
Title
Length of Stay
Description
Length of stay will be collected via retrospective patient chart review or from patient care team upon discharge
Time Frame
time of discharge up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew E Peters, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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

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