- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06049420
Lifestyle Medicine: Establishing Clinical Approaches to Chronic Disease for Rural Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will have the option to opt-in to this program if they receive a referral from their primary care physician at the Robert C. Byrd Clinic (RCBC). The referral period will be one month long, followed by 3 months of wellness facility access (intervention period). This pilot program will be restricted to adults (18-64 years old) with two or more diagnosed chronic diseases. Program admittance will be restricted to patients with diseases that have sufficient evidence for the efficacy of exercise therapy. As patients will be referred to the program, they will all have physician consent to participate in supervised physical activity. Standard care will proceed as determined by the primary care physician, as this program will be adjunctive treatment. As patient recruitment is contingent on physician referrals, the investigators have established a strong network with the family care physicians and administration from RCBC, and they are very confident that this program will be in high demand. Physicians will be reminded of the recruitment time 1-2 times/month for the 3 months preceding the start date by email, personal communication, and lunch seminars. Prior to accessing the wellness facility, each patient will be scheduled for an intake meeting. This intake meeting will be used to collect patient information (such as vital signs, morphometrics, demographics, physical activity history and readiness, health history, etc.), and understand patient goals (weight loss, glucose management, pain relief, blood pressure management, etc.). A patient questionnaire will be developed for this meeting, and patients will also fill out a physical activity readiness questionnaire. Motivational interviewing techniques will be implemented to promote adherence to the program. Individualized goals will be determined and recorded. Patient preferences such as individual training/coaching vs. group fitness will also be determined. Following the intake meeting, each patient will be advised on how they may best reach their goals, and support will be provided by the PI or a trained medical student for implementation of physical activity. The wellness facility (Greenbrier Valley Fitness) was specifically chosen as it offers a wide variety of exercise equipment and activities including strength training, cross training, group fitness, yoga, and many others. The PI or student research technicians will be present for questions, coaching, and monitoring at all times when the patient is being active. Each patient will be provided with personalized exercise therapy that is best suited for their personal goals and disease states.
An overarching goal is for each patient to achieve 150 minutes per week of moderate to vigorous physical activity. This benchmark was chosen as it is the current recommendation from the CDC [1], and has been demonstrated to be therapeutic for all, and curative for some, of the chronic diseases mentioned above [2,3]. Importantly, some patients may not make this goal within the allotted time-frame depending on their current fitness and disease states. In order to assess adherence and attrition, the investigators will have to assess individuals based on their individualized goals. Any participant that fails to attend >50% of their scheduled activities, or fails to show up at least once in the last 15 days of the study will count as drop-outs.
Data collected on patients will only occur after their referral to our program, so that no patient data will be shared between institutions (WVSOM and the Robert C. Byrd Clinic) and so that the investigators can properly deliver informed consent to patients that are willing to have their data used for research purposes. GraphPad Prism and excel software will be used to store and analyze the data, using the descriptive statistics and computational functions to provide count data and attrition rates. Additional analyses of factors such as disease prevalence, demographics, age, gender, and appropriate interactions may also be assessed contingent on the study population.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christopher L Pankey, Ph.D.
- Phone Number: 3047936576
- Email: cpankey@osteo.wvsom.edu
Study Locations
-
-
West Virginia
-
Lewisburg, West Virginia, United States, 24901
- West Virginia School of Osteopathic Medicine
-
Contact:
- Dovenia Ponnoth, Ph.D.
- Phone Number: 304-647-6297
- Email: dponnoth@osteo.wvsom.edu
-
Contact:
- Peter Feltman
- Phone Number: 3046476284
- Email: pfeltman@osteo.wvsom.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Program admittance will be restricted to patients with 2+ diagnosed diseases that have sufficient evidence for the efficacy of exercise therapy (obesity, hyperlipidemia, metabolic syndrome, polycystic ovarian syndrome, type II diabetes, hypertension, coronary heart disease, heart failure, depression, anxiety)
- physician referral required
Exclusion Criteria:
- no chronic disease diagnosis, lack of physician referral, unwillingness to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active
participants that have received a referral, and opt-in for the adjunctive treatment plan
|
Each participant will be provided with personalized exercise therapy that is best suited for their personal goals and disease states.
Participants in this study will be encouraged to establish accountability through setting SMART goals, and through monitoring their activity using wearable fitness technology provided to them.
This program will also aim to create a sense of community as group activity classes will be available for those that wish to attend.
Individualized exercise/physical activity prescriptions will be provided and discussed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demand
Time Frame: 1 month
|
initial demand for the program
|
1 month
|
Attrition rate
Time Frame: 4 months
|
Drop out rate after opting in to the intervention
|
4 months
|
physical activity
Time Frame: 4 months
|
minutes of moderate to vigorous physical activity
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: 4 Months
|
Systolic and diastolic blood pressure (mmHg)
|
4 Months
|
Blood glucose
Time Frame: 4 Months
|
mg/dL
|
4 Months
|
blood lipids
Time Frame: 4 Months
|
triglycerides (mg/dL)
|
4 Months
|
Glycosylated hemoglobin
Time Frame: 4 Months
|
A1C (percent of hemoglobin that is glycosylated)
|
4 Months
|
BMI
Time Frame: 4 Months
|
weight and height will be combined to report BMI in kg/m^2
|
4 Months
|
total cholesterol
Time Frame: 4 Months
|
Triglycerides, High density lipoproteins (HDL) and low density lipoproteins (LDL) will be used to determine total cholesterol.
|
4 Months
|
Self-efficacy
Time Frame: 4 Months
|
Exercise Self Efficacy scale - ranges from 0 (low self efficacy) to 10 (high self efficacy) These data measure individual's confidence in his or her capacity to execute behaviors necessary to maintain an active lifestyle. |
4 Months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christopher L Pankey, Ph.D., West Virginia School of Osteopathic Medicine
Publications and helpful links
General Publications
- Palakodeti S, Uratsu CS, Schmittdiel JA, Grant RW. Changes in physical activity among adults with diabetes: a longitudinal cohort study of inactive patients with Type 2 diabetes who become physically active. Diabet Med. 2015 Aug;32(8):1051-7. doi: 10.1111/dme.12748. Epub 2015 Apr 10.
- Hupin D, Roche F, Gremeaux V, Chatard JC, Oriol M, Gaspoz JM, Barthelemy JC, Edouard P. Even a low-dose of moderate-to-vigorous physical activity reduces mortality by 22% in adults aged >/=60 years: a systematic review and meta-analysis. Br J Sports Med. 2015 Oct;49(19):1262-7. doi: 10.1136/bjsports-2014-094306. Epub 2015 Aug 3.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Neoplasms
- Endocrine System Diseases
- Disease Attributes
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Insulin Resistance
- Hyperinsulinism
- Lipid Metabolism Disorders
- Dyslipidemias
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Coronary Disease
- Polycystic Ovary Syndrome
- Syndrome
- Metabolic Syndrome
- Chronic Disease
- Hyperlipidemias
Other Study ID Numbers
- R010422CP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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