Psychiatric HospitalizationNCT05859204
Impact of Exercise Groups on Patient Mental Health and Wellbeing in an Acute Psychiatric Inpatient Unit
A study testing OT-led Exercise Group and Treatment as Usual - OT Groups in people with Psychiatric Hospitalization and Physical Inactivity, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Hospitalization, Physical Inactivity, Depression, Anxiety
- What is being tested?
- OT-led Exercise Group and Treatment as Usual - OT Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
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).
Read the 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.
- Being tested
- OT-led Exercise Group, Treatment as Usual - OT Groups
- Medical subject headings
- Sedentary Behavior, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT-led Exercise GroupBehavioural
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.
Treatment as Usual - OT GroupsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: OT-led Exercise Group |
| 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. Receives: Behavioral: Treatment as Usual - OT Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression using Patient Health Questionnaire-9
Patient Health Questionnaire-9, range 0-27, lower score better outcome
Measured: baseline, time of discharge up to 6 months
Change in anxiety using Generalized Anxiety Disorder-7
Generalized Anxiety Disorder-7, range 0-21, lower score better outcome
Measured: baseline, time of discharge up to 6 months
Change in sleep using Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index, range 0-21, lower score better outcome
Measured: baseline, time of discharge up to 6 months
Secondary outcomes (1)
Length of Stay
Length of stay will be collected via retrospective patient chart review or from patient care team upon discharge
Measured: time of discharge up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Aug 2023
- Primary completion31 Jul 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric HospitalizationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew E Peters, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859204
- Sponsor's protocol ID
- IRB00373975
- Status last verified
- Jul 2026
- First submitted
- 4 May 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise Groups on Patient Mental Health and Wellbeing in an Acute Psychiatric Inpatient Unit
- ClinicalTrials.gov ID
- NCT05859204
- Acronym / sponsor ID
- IRB00373975
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OT-led Exercise Group on Inpatient Psychiatry Unit | Experimental | Behavioral: OT-led Exercise GroupOccupational 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. |
| Treatment As Usual - OT Groups on Inpatient Psychiatry Unit | Placebo comparator | Behavioral: Treatment as Usual - OT GroupsAn occupational therapist (OT) will begin daily educational session about the topic of choice for that day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OT-led Exercise GroupParticipants 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. | Behavioural | OT-led Exercise Group on Inpatient Psychiatry Unit |
| Treatment as Usual - OT GroupsParticipants 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. | Behavioural | Treatment As Usual - OT Groups on Inpatient Psychiatry Unit |
Primary outcome
Change in depression using Patient Health Questionnaire-9
Time frame: 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
Time frame: 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
Time frame: baseline, time of discharge up to 6 months
Pittsburgh Sleep Quality Index, range 0-21, lower score better outcome
1 secondary outcome
Length of Stay
Time frame: time of discharge up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Related trials for Psychiatric Hospitalization
Enrolling by invitation
Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression
Insomnia, Depression
Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Suicidal Ideation, Suicidal Behavior
Recruiting
A Brief Case Management Intervention to Promote Personal Recovery and Prevent Psychiatric Involuntary Readmissions.
Psychiatric Disorder, Involuntary Psychiatric Hospitalization
Not yet recruitingObservational study
Community-Based Intensive Treatment (CBIT): Meeting the Complex Needs of Rural Adults With Serious Mental Illness
Severe Mental Illness, Hospitalizations Psychiatric
RecruitingObservational study
Psychosocial Factors in Dual Diagnosis in a General Hospital
Dual Diagnosis, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew E Peters, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OT-led Exercise Group and Treatment as Usual - OT Groups in people with Psychiatric Hospitalization and Physical Inactivity, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression using Patient Health Questionnaire-9 (time frame: baseline, time of discharge up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.