Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-27 @ 6:44 AM
Study NCT ID:
NCT05041634
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2021-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity for People With Behavioral Diagnoses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'pilot study of single group pre/post design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-03', 'studyFirstSubmitDate': '2021-09-03', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood Lipids', 'timeFrame': 'week1 and week 14', 'description': 'hemoglobin, cholesterol, lipids, insulin, glucose, triglycerides, high-density lipoproteins;'}], 'primaryOutcomes': [{'measure': 'Canadian Occupational Performance Measure', 'timeFrame': 'pre and post 14 week intervention', 'description': 'self-rating goal tool'}, {'measure': 'Coach Fidelity Log Sheet', 'timeFrame': 'first 8 weeks', 'description': 'Coaches collected data for consistency of intervention'}, {'measure': 'PHQ-9', 'timeFrame': 'week1 and week 14', 'description': 'self-rating depression screener'}, {'measure': 'GAD', 'timeFrame': 'week1 and week 14', 'description': 'Self-rated anxiety scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise, healthy habits, self-management'], 'conditions': ['Severe Mental Illness']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nOur 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.\n\nResearch Questions:\n\nHow 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?\n\nEXPERIMENTAL DESIGN:\n\nThis 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.\n\nPROPOSED PROCEDURE:\n\nAssessments include biophysical markers of health, self-reported psychosocial measures, and records of exercise and activity. Specifically, we will measure:\n\nCholesterol, 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.\n\nBlood 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll 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\n\nExclusion Criteria:\n\nUnder the age of 21 or who are not psychologically stable in the last month'}, 'identificationModule': {'nctId': 'NCT05041634', 'briefTitle': 'Physical Activity for People With Behavioral Diagnoses', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'The Physical and Psychosocial Influences of an Exercise and Activity Program on People With Behavioral Diagnoses: A Cohort Study', 'orgStudyIdInfo': {'id': '9088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Group Pilot study pre/post', 'description': 'One group of 8 participants receiving 14 week intervention', 'interventionNames': ['Behavioral: IHOPE']}], 'interventions': [{'name': 'IHOPE', 'type': 'BEHAVIORAL', 'description': 'Integrating Healthy Habits Optimized by Community Participation and Engagled Learning', 'armGroupLabels': ['Single Group Pilot study pre/post']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74135', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}