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Behavioural Intervention
Exercise Monitoring System for Osteoarthritis
Phase 1 & 2
Recruiting
Research Sponsored by University of Southern Mississippi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre - post 12 weeks
Awards & highlights
Study Summary
This trial is looking at a new way to exercise safely for people with obesity and osteoarthritis, to help them feel less pain and improve their health and fitness.
Who is the study for?
This trial is for adults aged 30-75 with obesity (BMI between 30.0 and 50.0) who are sedentary, have medical clearance, and knee pain from osteoarthritis but no recent severe heart issues, joint surgeries, or certain other health conditions like dementia or terminal illnesses.Check my eligibility
What is being tested?
The study tests a hip flexion feedback system (HFFS) that guides knee-lifting exercises on a treadmill based on real-time heart rate to improve fitness and reduce pain in people with osteoarthritis and obesity compared to those not exercising.See study design
What are the potential side effects?
While the document doesn't list specific side effects of HFFS exercise, potential risks may include muscle soreness or strain due to high-intensity activity especially in individuals unaccustomed to regular exercise.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre - post 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre - post 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Balance
Body Composition
Cardiorespiratory Fitness
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
This group will do a 12-week high intensity exercise program. The subjects will exercise by increasing how much they lift their knees while walking on treadmill. The exercise will also involve controlling the impact of the feet on the treadmill. A TV placed in front of the treadmill shows how high individuals need to lift their knees. How much participants need to lift their knees is calculated based on real-time heart rate readings.
Group II: ControlActive Control1 Intervention
This group will do initially a 12-week period of no intervention. After these 12 weeks, participants will do a 12-week high intensity exercise program. The subjects will exercise by increasing how much they lift their knees while walking on treadmill. The exercise will also involve controlling the impact of the feet on the treadmill. A TV placed in front of the treadmill shows how high individuals need to lift their knees. How much participants need to lift their knees is calculated based on real-time heart rate readings.
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Who is running the clinical trial?
University of Southern MississippiLead Sponsor
13 Previous Clinical Trials
2,891 Total Patients Enrolled
3 Trials studying Obesity
89 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have knee pain diagnosed as osteoarthritis with a specific pain score.I haven't been hospitalized for stroke, heart attack, or heart surgery in the last 3 months.I have severe dementia or significant memory loss.I am between 30 and 75 years old.I have had knee surgery or a knee injury in the last 6 months.I have had or will have a joint injection within the next 3 months.I have fibromyalgia, rheumatoid arthritis, or another similar condition.I am on a waiting list for a joint replacement surgery.I have severe hearing or speech impairments.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research encompass individuals aged sixty and over?
"For this trial, researchers are looking for individuals aged 30 and above but no older than 75."
Answered by AI
Is there still room for enrolment in this trial?
"Affirmative. Information listed on clinicaltrials.gov states that this experiment is currently accepting patients for enrollment. It was initially posted on July 1st 2023, and its most recent update was August 11th 2023. The trial requires 24 participants from a single site to participate in the study."
Answered by AI
Am I eligible to become a participant in this research endeavor?
"In order to be a part of this research, individuals must have osteoarthritis and fall within the ages 30-75. Currently, 24 participants are being sought for the clinical trial."
Answered by AI
What is the total enrollment number for this trial?
"Affirmative. According to clinicaltrials.gov, this medical study is still recruiting participants and was first published on July 1st 2023, with the latest revision occurring on August 11th of that same year. The trial aims to enrol 24 patients at a single site."
Answered by AI
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