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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	30 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05997862
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Southern Mississippi
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Knee, Obesity

Arms & Interventions

Arms

Experimental: 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.

No Intervention: Control

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.

Interventions

Device: - HFFS

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University Southern Mississippi, Hattiesburg, Mississippi

Status

Recruiting

Address

University Southern Mississippi

Hattiesburg, Mississippi, 39402-7326

Site Contact

Nuno Oliveira

[email protected]

601-266-5804

Clinical Trial Finder