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Physical Activity for People With Behavioral Diagnoses

Primary Purpose

Severe Mental Illness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IHOPE
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Mental Illness focused on measuring exercise, healthy habits, self-management

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All study participants will be over the age of 21 and will include women and likely some individuals who report minority status with a mental health diagnosis

Exclusion Criteria:

Under the age of 21 or who are not psychologically stable in the last month

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Group Pilot study pre/post

Arm Description

One group of 8 participants receiving 14 week intervention

Outcomes

Primary Outcome Measures

Canadian Occupational Performance Measure
self-rating goal tool
Coach Fidelity Log Sheet
Coaches collected data for consistency of intervention
PHQ-9
self-rating depression screener
GAD
Self-rated anxiety scale

Secondary Outcome Measures

Full Information

First Posted
September 3, 2021
Last Updated
September 3, 2021
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT05041634
Brief Title
Physical Activity for People With Behavioral Diagnoses
Official Title
The Physical and Psychosocial Influences of an Exercise and Activity Program on People With Behavioral Diagnoses: A Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
December 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

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
Our aims are to 1) test that our intervention that can be measured with high fidelity. 2) determine the feasibility of the intervention including recruitment, procedures, measures, intervention acceptability and resources . 3)We will also test the outcomes of this 14-week fitness and wellness program based at a YMCA Healthy Living Center to gauge the effects of exercise and activity on patients with behavioral diagnoses including bipolar disorder, schizoaffective disorder, and schizophrenia. We also want to explore the influence of participating in such a program on the perceptions of mental illness among rehabilitation sciences students.
Detailed Description
Our aims are to 1) test that our intervention that can be measured with high fidelity. 2) determine the feasibility of the intervention including recruitment, procedures, measures, intervention acceptability and resources . 3)We will also test the outcomes of this 14-week fitness and wellness program based at a YMCA Healthy Living Center to gauge the effects of exercise and activity on patients with behavioral diagnoses including bipolar disorder, schizoaffective disorder, and schizophrenia. We also want to explore the influence of participating in such a program on the perceptions of mental illness among rehabilitation sciences students. Our hypotheses are 1) that a fitness and activity program using physical activity, group discussion, and education delivered in a fitness facility will reduce anxiety and depression and strengthen hope, self-esteem, and improve overall quality of life; and 2) that student perceptions of mental illness will improve after participating in such a fitness and activity program. Research Questions: How does a program of exercise and activity influence the physical health of people with behavioural diagnoses as it relates to venous blood plasma measures of haemoglobin, cholesterol, lipids, insulin, glucose, triglycerides, high-density lipoproteins; height, weight, abdominal girth, blood pressure and heart rate; strength; and capacity for physical activity? How does a program of exercise and activity influence the psychosocial health of people with behavioural diagnoses as it relates to measures of hope, depression, anxiety, and self-esteem? How does a program of exercise and activity influence occupational performance and satisfaction of people with a behavioural diagnoses? How does a program of exercise and activity influence quality of life for people with a behavioral diagnoses ? How does participating in a program of exercise and activity influence the overall perceptions of people with behavioural diagnoses? What is the feasibility and fidelity of this 14-week intervention? How does being part of a program of exercise and activity for people with behavioural diagnoses influence perceptions of rehabilitation sciences students about mental illness? EXPERIMENTAL DESIGN: This follow up study involves a group of up to ten past participants recruited from patients being treated by the OU-Tulsa IMPACT Team. We will conduct interviews and baseline measures to compare to past progress. This study will serve to inform future cohorts for the original study protocol. PROPOSED PROCEDURE: Assessments include biophysical markers of health, self-reported psychosocial measures, and records of exercise and activity. Specifically, we will measure: Cholesterol, lipids, and glucose/ A1C via blood specimens collected as a routine part of the patient's care Height and weight via stadiometer and digital scale, abdominal girth (the narrowest point between the xiphoid process and the navel) using a Gulick tape measure. Blood pressure using a sphygmomanometer & heart rate by counting the pulse for 60 seconds using a digital timer Cardiovascular endurance via the three-minute step test Depression via the PHQ9 scale Anxiety using the Generalized Anxiety Disorder Test Interview/Focus Group Mental Illness Clinician Attitude Scale (MICA) This brief follow up study will assess participants who are one year out from the program or more. The study will take place in their residence and include the measures stated above and an interview. Researchers want to understand how the program is beneficial after one year and what can be improved to maintain benefits if any. Findings will be used to adjust the original protocol if needed to continue the original study. The assessments and interviews will be completed by researchers and occupational and physical therapy students under the supervision of their faculty. In addition, participants will be offered educational materials to help resume healthy habits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Mental Illness
Keywords
exercise, healthy habits, self-management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pilot study of single group pre/post design
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Group Pilot study pre/post
Arm Type
Experimental
Arm Description
One group of 8 participants receiving 14 week intervention
Intervention Type
Behavioral
Intervention Name(s)
IHOPE
Intervention Description
Integrating Healthy Habits Optimized by Community Participation and Engagled Learning
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure
Description
self-rating goal tool
Time Frame
pre and post 14 week intervention
Title
Coach Fidelity Log Sheet
Description
Coaches collected data for consistency of intervention
Time Frame
first 8 weeks
Title
PHQ-9
Description
self-rating depression screener
Time Frame
week1 and week 14
Title
GAD
Description
Self-rated anxiety scale
Time Frame
week1 and week 14
Other Pre-specified Outcome Measures:
Title
Blood Lipids
Description
hemoglobin, cholesterol, lipids, insulin, glucose, triglycerides, high-density lipoproteins;
Time Frame
week1 and week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All study participants will be over the age of 21 and will include women and likely some individuals who report minority status with a mental health diagnosis Exclusion Criteria: Under the age of 21 or who are not psychologically stable in the last month
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Physical Activity for People With Behavioral Diagnoses

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