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NCT05997862 | RECRUITING | Osteoarthritis, Knee

A Hip Flexion Feedback System for Exercise Monitoring in Individuals With Osteoarthritis and Obesity
Sponsor:

University of Southern Mississippi

Information provided by (Responsible Party):

Nuno Oliveira

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.

Condition or disease

Osteoarthritis, Knee

Obesity

Intervention/treatment

HFFS

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : A Hip Flexion Feedback System for Exercise Monitoring in Individuals With Osteoarthritis and Obesity
Actual Study Start Date : 2023-07-01
Estimated Primary Completion Date : 2025-09-30
Estimated Study Completion Date : 2026-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Hip Flexion Feedback System for Exercise Monitoring in Individuals With Osteoarthritis and Obesity

Location Details

NCT05997862

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Locations

RECRUITING

United States, Mississippi

University Southern Mississippi

Hattiesburg, Mississippi, United States, 39402-7326