Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05041634 |
| Other study ID # |
9088 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2019 |
| Est. completion date |
December 16, 2019 |
Study information
| Verified date |
September 2021 |
| Source |
University of Oklahoma |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
