Clinical trial NCT05997862: A Hip Flexion Feedback System for Exercise Monitoring in Individuals With Osteoarthritis and Obesity
Official title: A Hip Flexion Feedback System for Exercise Monitoring in Individuals With Osteoarthritis and Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis, Knee
Obesity
Keywords: Exercise
Osteoarthritis
Obesity
Lead sponsor: University of Southern Mississippi
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exercise is very important for living healthier and longer lives. For people with obesity and osteoarthritis, exercise is even more important because it can help them feel less pain in their joints. Also, the more intense the exercise is, the larger the health benefits will be. The most common ways to exercise are running and riding a stationary bicycle. However, these two types of exercise can cause problems for people with obesity and osteoarthritis. Fast running creates large loads in the knees because of the impact of the foot on the ground. On the other hand, studies in cycling show limited improvement in pain because cycling does not allow the feet to move freely, which is important for reducing pain in people with osteoarthritis. This study introduces a new way to exercise using a hip flexion feedback system (HFFS). 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. The HFFS monitors the subject's heart rate during the exercise using a standard heart rate monitor. 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 by the HFFS based on real-time heart rate readings. Therefore, the HFFS can help people stay at a specific exercise intensity by controlling how high it tells them lift their knees during the exercise. This study will have participants with osteoarthritis and obesity in two groups. One group will exercise using the HFFS. Another group will not exercise. The exercise group will do a 12-week high intensity exercise program. Our first goal is to determine how much fitness, pain, and the ability to move improve due to the exercise program. With this study we are looking to introduce a better and safer way to exercise for people with osteoarthritis and obesity. The results of this study will also allow for further development of home-based exercise and telemedicine.


Eligibility criteria: Inclusion Criteria:

* Age 30 to 75 years;
* BMI ≥ 30.0 kg/m2 and ≤ 50.0 kg/m2;
* Symptomatic knee OA (defined as a self- report of physician diagnosis of knee OA and current knee symptoms in at least one knee determined from a minimum score of 5 of 20 on the pain subscale of the WOMAC).
* Sedentary (not meeting ACSM guidelines for physical activity)
* Medical clearance for participation

Exclusion Criteria:

* Self- reported fibromyalgia, rheumatoid arthritis, or other systemic rheumatic disease.
* Severe dementia or other memory loss condition
* Active diagnosis of psychosis or current uncontrolled substance abuse disorder
* Has been hospitalized for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 3 months
* Had a total joint replacement knee surgery, other knee surgery, meniscus tear, or anterior cruciate ligament tear in the past 6 months
* Is on a waiting list for total joint replacement
* Had an intra-articular injection in past 3 months or scheduled during the study period;
* Has severely impaired hearing or speech
* Is pregnant
* Has a serious or terminal illness as indicated by referral to hospice or palliative care
* Resides in a nursing home
* Has any other health problems that would prohibit safe participation in the study

Primary outcomes:
measure: Cardiorespiratory Fitness
timeFrame: Pre - Post 12 weeks
measure: Resting Cardiovascular Function
timeFrame: Pre - Post 12 weeks
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Pre - Post 12 weeks
measure: Physical function
timeFrame: Pre - Post 12 weeks
measure: Balance
timeFrame: Pre - Post 12 weeks
measure: Muscle Strength
timeFrame: Pre - Post 12 weeks
measure: Body Composition
timeFrame: Pre - Post 12 weeks
measure: Fasting Blood Glucose
timeFrame: Pre - Post 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hattiesburg
country: United States
facility: University Southern Mississippi
state: Mississippi
Study officials:
References: