Exercise Monitoring System for Osteoarthritis

Overseen By Sam Bruton

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Southern Mississippi

Disqualifiers: Fibromyalgia, Rheumatoid arthritis, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new exercise method using a hip flexion feedback system (HFFS) for individuals with obesity and osteoarthritis. The goal is to determine if this system can improve fitness, reduce pain, and enhance mobility. Participants will either use the HFFS in a 12-week exercise program or wait 12 weeks before starting the same program. The trial seeks individuals with knee osteoarthritis, a body mass index (BMI) of 30 or higher, and a sedentary lifestyle. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study coordinators or your doctor.

What prior data suggests that the Hip Flexion Feedback System is safe for people with osteoarthritis and obesity?

Research has shown that a Hip Flexion Feedback System (HFFS) might provide a safe exercise option for individuals with osteoarthritis and obesity. A review of 37 studies involving 1,235 participants found that exercises focusing on the knees and hips, combined with feedback systems like the HFFS, can help reduce knee pain. This indicates that most people can use the HFFS without major side effects.

The trial remains in its early stages, and researchers continue to gather safety information. However, the trial's progression to this stage suggests that earlier research found the HFFS safe for participants. The system is designed to offer a more controlled and safer exercise method, potentially resulting in fewer injuries or problems compared to traditional exercises like running or cycling. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise Monitoring System for Osteoarthritis because it introduces a novel way of managing osteoarthritis symptoms through real-time feedback during exercise. Unlike traditional treatments like medications, physical therapy, or surgery, this system uses a Hip Flexion Feedback System (HFFS) to guide high-intensity exercise by providing visual cues on a TV screen, helping participants adjust knee lift and foot impact based on their heart rate. This approach not only personalizes the exercise regimen but also aims to enhance muscle strength and joint function more effectively and safely. By potentially improving exercise outcomes, this method could offer a non-invasive alternative to managing osteoarthritis, which is a significant advancement over existing options.

What evidence suggests that the Hip Flexion Feedback System is effective for osteoarthritis?

Research has shown that a Hip Flexion Feedback System (HFFS) could be a beneficial exercise tool for individuals with osteoarthritis and obesity. Early results suggest that this system, which controls knee movement and foot impact during treadmill walking, may enhance fitness and reduce joint pain. In this trial, participants in the intervention group will use the HFFS during a 12-week high-intensity exercise program. A similar study with patients experiencing hip problems demonstrated significant improvements in hip function after using exercise monitoring systems. This suggests that the HFFS might enhance movement and alleviate pain in those with osteoarthritis. The system aims to make exercise safer and more effective by adjusting intensity based on heart rate. Overall, early indications show potential benefits for pain relief and improved movement. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 30-75 with obesity (BMI between 30.0 and 50.0) who are sedentary, have medical clearance, and knee pain from osteoarthritis but no recent severe heart issues, joint surgeries, or certain other health conditions like dementia or terminal illnesses.

Inclusion Criteria

I have knee pain diagnosed as osteoarthritis with a specific pain score.

Sedentary (not meeting ACSM guidelines for physical activity)

BMI ≥ 30.0 kg/m2 and ≤ 50.0 kg/m2

Exclusion Criteria

Active diagnosis of psychosis or current uncontrolled substance abuse disorder

Pregnancy

Serious or terminal illness as indicated by referral to hospice or palliative care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the exercise group will undergo a 12-week high intensity exercise program using the Hip Flexion Feedback System (HFFS) to monitor and adjust exercise intensity.

12 weeks

Weekly in-person visits for exercise sessions

Control

Participants in the control group will have a 12-week period of no intervention followed by a 12-week high intensity exercise program.

24 weeks

Bi-weekly in-person visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cardiovascular function, fasting blood glucose, balance, body composition, physical function, muscle strength, cardiorespiratory fitness, and osteoarthritis symptoms.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hip Flexion Feedback System (HFFS)

Trial Overview The study tests a hip flexion feedback system (HFFS) that guides knee-lifting exercises on a treadmill based on real-time heart rate to improve fitness and reduce pain in people with osteoarthritis and obesity compared to those not exercising.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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 II: Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Southern Mississippi

Lead Sponsor

Trials

16

Recruited

3,200+

Published Research Related to This Trial

A new wearable sensor array has been developed to monitor the correctness of home-based physical therapy exercises for chronic low back pain, achieving 70-100% sensitivity and 100% specificity in recognizing correct movements during pilot tests.

This method allows for real-time biofeedback and could improve compliance and outcomes in unsupervised physical therapy programs, making it easier to assess the effectiveness of home exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Sensor Array Design for Spine Posture Monitoring During Exercise Incorporating Biofeedback. Caviedes, JE., Li, B., Jammula, VC.[2021]

A study involving 289 patients who underwent arthroscopic surgery for femoroacetabular impingement (FAI) showed significant improvements in hip function and quality of life measures at a mean follow-up of 25.4 months, with all validated outcome scores improving (e.g., iHOT-12 scores increased from 43 to 66).

At the 2-year follow-up, 82% of patients reported satisfaction with their surgical outcomes, indicating that arthroscopic treatment for FAI is both effective and well-received by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome after hip arthroscopy for femoroacetabular impingement in 289 patients with minimum 2-year follow-up. Sansone, M., Ahldén, M., Jónasson, P., et al.[2022]

A systematic review of 37 trials involving 1235 participants found that combining knee/hip exercises with internal feedback significantly reduces frontal knee movements in individuals with patellofemoral pain, indicating a strong therapeutic effect.

This combination of interventions also effectively reduces frontal hip movements and increases sagittal knee movements, while single applications of braces or taping showed little to no impact on movement changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Interventions Aimed at Changing Movement Patterns in People With Patellofemoral Pain: A Systematic Review With Network Meta-analysis. Nunes, GS., de Oliveira, J., Iacob, GS., et al.[2023]

A study of 44 patients who underwent total hip arthroplasty (THA) showed that a hybrid physiotherapy regime using an anti-gravity treadmill and low-frequency electrical stimulation helped maintain lower limb muscle strength and endurance post-surgery.

In contrast, the conventional rehabilitation group experienced a significant decrease in knee extension strength and walking distance two weeks after surgery, highlighting the potential benefits of the hybrid approach for early recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Simultaneous Antigravity Treadmill Training and Electrical Muscle Stimulation After Total Hip Arthroplasty: Short Follow-Up Time. Mikami, Y., Orita, N., Yamasaki, T., et al.[2020]

The modified Intelligent Device for Energy Expenditure and Activity (IDEEA) demonstrated high accuracy in measuring knee flexion angles, with correlations of 0.97 to 0.98 when compared to the gold standard data from the Biomotion Laboratory in various activities.

The IDEEA effectively detected common physical activities like walking and running in everyday settings, but found that healthy subjects rarely flexed their knees beyond 120 degrees during normal activities, indicating its potential for monitoring joint motion in real-life scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory measurement of knee motion and physical activity: preliminary evaluation of a smart activity monitor. Huddleston, J., Alaiti, A., Goldvasser, D., et al.[2018]

The developed algorithm effectively classifies activities related to knee joint health by analyzing acoustical emissions during movements like flexion-extension and sit-to-stand, based on data from eight healthy subjects.

This system allows for real-time monitoring and energy-efficient recording of knee joint sounds, which could be useful for assessing rehabilitation progress after knee injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time activity classification in a wearable system prototype for knee health assessment via joint sounds. Toreyin, H., Hyeon Ki Jeong, ., Hersek, S., et al.[2020]

The study analyzed the kinematics of the overhead deep squat (OHDS) in 45 healthy adults and found that higher FMS scores (specifically a score of 3) were associated with greater peak hip flexion, knee flexion, and ankle dorsiflexion angles, indicating better squat depth.

However, no significant differences were observed between individuals scoring 2 and 1, suggesting that the FMS scoring may not effectively differentiate kinematic risks for lower extremity injuries, particularly in frontal and transverse plane movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Lower Extremity Kinematics during the Overhead Deep Squat by Functional Movement Screen Score. Heredia, C., Lockie, RG., Lynn, SK., et al.[2022]

A new wearable device was developed to measure joint flexion and physical activity, showing strong correlation with traditional motion capture systems, making it a reliable tool for assessing post-operative recovery.

In a study with pigs after knee surgery, the device revealed that physical activity decreased immediately post-surgery but returned to pre-operative levels within two weeks, highlighting its potential for monitoring recovery in real-time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wearable Magnet-Based System to Assess Activity and Joint Flexion in Humans and Large Animals. Qu, F., Stoeckl, BD., Gebhard, PM., et al.[2019]

Accelerometer-based activity monitoring is a practical and effective method for measuring physical activity in orthopaedic patients, providing valuable data that complements traditional assessments of physical function and pain.

This technology can help clinicians track patients' activity levels over time, enabling better coaching towards achieving physical activity goals and promoting a more active lifestyle during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of accelerometer-based activity monitoring in orthopaedics: benefits, impact and practical considerations. Sliepen, M., Lipperts, M., Tjur, M., et al.[2020]

The H-Gait system, using wearable magneto-inertial sensors, showed high consistency with the reference STEP32 system for measuring gait cadence, indicating its potential for accurate gait analysis in both normal weight and overweight/obese individuals.

While joint kinematics were generally comparable between the two systems, significant discrepancies were noted for hip joint range of motion, suggesting that while H-Gait is effective, careful consideration is needed for hip measurements when using this system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wearable Magneto-Inertial System for Gait Analysis (H-Gait): Validation on Normal Weight and Overweight/Obese Young Healthy Adults. Agostini, V., Gastaldi, L., Rosso, V., et al.[2019]

A 12-week progressive exercise therapy program for patients with femoroacetabular impingement syndrome (FAIS) resulted in significant improvements in hip pain and function, which were maintained over a mid-term follow-up of 4.6 years for those who did not undergo surgery.

While patients showed improved hip function compared to their pre-therapy status, their level of sports activity remained lower than their pre-symptomatic levels, indicating some limitations in returning to full athletic performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mid-term outcomes of exercise therapy for the non-surgical management of femoroacetabular impingement syndrome: are short-term effects persisting? Monn, S., Maffiuletti, NA., Bizzini, M., et al.[2022]

Supervised progressive resistance training significantly improved patient-reported function, hip-related pain, and health-related quality of life in 189 participants with hip osteoarthritis, compared to common treatments.

Despite these positive outcomes, the overall quality of evidence was rated low due to issues like lack of blinding in the studies, indicating that further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of supervised resistance training for patients with hip osteoarthritis - a systematic review. Hansen, S., Mikkelsen, LR., Overgaard, S., et al.[2021]

The Hip Sports Activity Scale (HSAS-Brazil) was validated as a reliable tool for assessing physical activity levels in patients with femoroacetabular impingement (FAI) syndrome after hip arthroscopy, showing a high test-retest reliability (interclass correlation of 0.908).

The HSAS-Brazil demonstrated significant correlations with other established health measures, indicating its effectiveness in evaluating treatment outcomes in active patients with FAI syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Brazilian version of the Hip Sports Activity Scale (HSAS) for patients with femoroacetabular impingement: a cross-sectional study. Mathias, LNCDC., Cardinot, TM., Sá-Caputo, DDC., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05997862

A Hip Flexion Feedback System for Exercise Monitoring in ... 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 ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT05997862

A Hip Flexion Feedback System for Exercise Monitoring in ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11005282/

Usability and preliminary effectiveness of an app-based ... To examine pain and physical functioning in daily living, the Hip Disability and Osteoarthritis Outcome Score (HOOS) pain and functioning in ...

4. withpower.com withpower.com/trial/phase-2-osteoarthritis-6-2023-db93a

Exercise Monitoring System for Osteoarthritis A study involving 289 patients who underwent arthroscopic surgery for femoroacetabular impingement (FAI) showed significant improvements in hip function and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11420596/

Efficacy of the mHealth-Based Exercise Intervention re.flex ... This study aims to evaluate the efficacy of a 12-week fully automated app-based exercise intervention with and without a supporting knee brace on health-related ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00682617

Hip Osteoarthritis: Effects of Exercise Programs on Pain ... Outcome assessment will follow the Outcome Measures in Rheumatology (OMERACT) recommendations for a core set of outcome measures for clinical trials in ...