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

NCT ID: NCT05997862

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2026-03-31

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.

Conditions

Osteoarthritis, Knee; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 Type: EXPERIMENTAL

HFFS

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Mississippi

OTHER

Sponsor Role: lead

Responsible Party

Nuno Oliveira

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Southern Mississippi

Hattiesburg, Mississippi, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nuno Oliveira, PhD

Role: CONTACT

nuno.oliveira@usm.edu

601-266-5804

Sam Bruton

Role: CONTACT

samuel.bruton@usm.edu

601-266-6756

Facility Contacts

Nuno Oliveira

Role: primary

nuno.oliveira@usm.edu

601-266-5804

Other Identifiers

22-0210

Identifier Type: -

Identifier Source: org_study_id