NCT05997862

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

Status unknown Phase 1, PHASE2 Last updated 18 August 2023

What this trial tests

Phase 1, PHASE2 trial testing HFFS in Osteoarthritis, Knee in 24 participants. Status unknown.

Timeline

1 July 2023

Primary endpoint
30 September 2025

31 March 2026

Quick facts

Lead sponsor	University of Southern Mississippi
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	24
Start date	1 July 2023
Primary completion	30 September 2025
Estimated completion	31 March 2026
Sites	1 location across United States

Drugs / interventions tested

• HFFS

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →
• Obesity — all drugs for Obesity →

Sponsor

University of Southern Mississippi

Who can join

Adults 30 to 75, any sex, with Osteoarthritis, Knee or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exercise for osteoarthritis of the knee.
   Lawford BJ, Hall M, Hinman RS, Van der Esch M, et al · · 2024 · cited 37× · PMID 39625083 · DOI 10.1002/14651858.cd004376.pub4
2. Effects of a 12-week increased hip flexion gait exercise intervention in individuals with obesity and knee osteoarthritis: a randomized crossover feasibility study.
   Oliveira N, Stavres J, Chiu CY, Graybeal AJ. · · 2026 · PMID 42028108 · DOI 10.3389/fspor.2026.1791400