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

Sponsor
Johns Hopkins University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05859204
Collaborator
(none)
60
1
2
24
2.5

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: OT-led Exercise Group
  • Behavioral: Treatment as Usual - OT Groups
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Impact of Exercise Groups on Patient Mental Health and Wellbeing in an Acute Psychiatric Inpatient Unit
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: OT-led Exercise Group on Inpatient Psychiatry Unit

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.

Behavioral: OT-led Exercise Group
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.

Placebo Comparator: Treatment As Usual - OT Groups on Inpatient Psychiatry Unit

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

Behavioral: Treatment as Usual - OT Groups
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.

Outcome Measures

Primary Outcome Measures

  1. Change in depression using Patient Health Questionnaire-9 [baseline, time of discharge up to 6 months]

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

  2. Change in anxiety using Generalized Anxiety Disorder-7 [baseline, time of discharge up to 6 months]

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

  3. Change in sleep using Pittsburgh Sleep Quality Index [baseline, time of discharge up to 6 months]

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

Secondary Outcome Measures

  1. Length of Stay [time of discharge up to 6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Bayview Medical Center Baltimore Maryland United States 21224

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

  • Principal Investigator: Matthew E Peters, MD, Johns Hopkins School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT05859204
Other Study ID Numbers:
  • IRB00373975
First Posted:
May 15, 2023
Last Update Posted:
May 15, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 15, 2023