Osteoarthritis, KneePhase 1/2NCT05997862
A Hip Flexion Feedback System for Exercise Monitoring in Individuals With Osteoarthritis and Obesity
A Phase 1/2 study testing HFFS in people with Osteoarthritis, Knee and Obesity, run by University of Southern Mississippi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee, Obesity
- What is being tested?
- HFFS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 31 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Southern Mississippi
Hattiesburg, Mississippi, 39402-7326
Nuno Oliveira, 601-266-5804, nuno.oliveira@usm.edu
About this study
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
- Being tested
- HFFS
- Keywords
- Exercise, Osteoarthritis, Obesity
- Medical subject headings
- Osteoarthritis, Knee, Obesity, Motor Activity, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFFSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Device: HFFS |
| Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness
Cardiorespiratory fitness will be quantified as peak oxygen consumption (VO2max) and walking efficiency. VO2max will be evaluated using a Balke treadmill exercise testing protocol [35]. This protocol maintains a constant speed during the test and progressively increases treadmill inclination (grade) until exhaustion. In contrast, walking efficiency will be evaluated using a submaximal exercise test (performed prior to the VO2max test). This submaximal exercise test will require participants to walk on a treadmill at a self-selected pace, during which time VO2 will be recorded.
Measured: Pre - Post 12 weeks
Resting Cardiovascular Function
Cardiovascular function will be quantified by resting blood pressure, heart rate, heart rate variability (HRV) and carotid-femoral pulse wave velocity (cfPWV). Blood pressure and heart rate will first be collected in the seated position using a manual sphygmomanometer according to the World Health Organization (WHO) recommendations. Next, heart rate will be recorded for approximately 10 minutes in the supine position, which will be used for assessment of HRV. During this collection period, participants will breathe at a rate of approximately 7 breaths per minute, which will be maintained using a metronome. The ECG data collected during this ten-minute period will then be analyzed using time domain HRV analysis and spectral HRV analysis. Lastly, cfPWV will be collected using applanation tonometry.
Measured: Pre - Post 12 weeks
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Subscales for pain, stiffness and physical function will be used to assess knee osteoarthritis symptomatic burden. The WOMAC includes a total of 24 items with subscales of pain (five items), stiffness (two items), and function (17 items), which are all rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total WOMAC score will be calculated (score range of 0- 96 [no to extreme problems]), as well as the pain (score 0- 20), stiffness (score 0- 8), and function (score 0- 68) subscales.
Measured: Pre - Post 12 weeks
Physical function
The 6-minute walk test (6MWT)
Measured: Pre - Post 12 weeks
Balance
Single leg stance time (the ability to stand on one limb unassisted) will be recorded in seconds (maximum time = 30 seconds) [43]. Three trials will be completed using an AMTI force platform (AMTI OPT464508HF sampling at 1000Hz; AMTI, USA) to assess postural balance control in quiet bipedal stance. Participants will stand as still as possible in a relaxed upright position with their feet parallel on predetermined marks (10 cm apart) and with their arms hanging against the thighs. Center of pressure displacement will be measured under two conditions: 1) eyes open; and 2) eyes closed. In the eyes open condition, participants will be asked to look at a target 2.5 m in front of them. In the eyes closed condition, a blindfold will be used to assure the absence of visual feedback.
Measured: Pre - Post 12 weeks
Muscle Strength
A Biodex isokinetic dynamometer (Biodex, Corp., Shirley, NY) will be used to measure the isometric strength of knee flexors and extensors.
Measured: Pre - Post 12 weeks
Body Composition
Whole-body and appendicular body (i.e., arms and legs) composition parameters including total fat mass, fat-free mass, body fat percent, and bioelectrical impedance (lower-body segmental extracellular and intracellular water content, resistance, reactance) will be performed throughout the intervention to assess tissue level improvements in body composition components specific to the desired outcomes of the intervention.
Measured: Pre - Post 12 weeks
Fasting Blood Glucose
FBG will be collected at baseline prior to the intervention and again at weeks 6 and 12. For measurements of FBG, participants will arrive at the laboratory after an overnight fast from food (≥ 8 hours) and abstention from exercise (≥ 12 hour). Upon arrival, participants FBG will be collected from capillary blood using a standard glucometer (KetoMojo, Napa, California, USA).
Measured: Pre - Post 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Jul 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Mississippi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuno Oliveira, University of Southern Mississippi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997862
- Sponsor's protocol ID
- 22-0210
- Status last verified
- Aug 2023
- First submitted
- 1 May 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Oliveira N, Stavres J, Chiu CY, Graybeal AJ. Effects of a 12-week increased hip flexion gait exercise intervention in individuals with obesity and knee osteoarthritis: a randomized crossover feasibility study. Front Sports Act Living. 2026 Apr 8;8:1791400. doi: 10.3389/fspor.2026.1791400. eCollection 2026.
PubMed 42028108
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hip Flexion Feedback System for Exercise Monitoring in Individuals With Osteoarthritis and Obesity
- ClinicalTrials.gov ID
- NCT05997862
- Acronym / sponsor ID
- 22-0210
- Conditions
- Osteoarthritis, Knee, Obesity
- Keywords
- Exercise, Osteoarthritis, Obesity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Southern MississippiUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: HFFSThis 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. |
| Control | No 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 may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFFSThis 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. | Device | Intervention |
Primary outcome
Cardiorespiratory Fitness
Time frame: Pre - Post 12 weeks
Cardiorespiratory fitness will be quantified as peak oxygen consumption (VO2max) and walking efficiency. VO2max will be evaluated using a Balke treadmill exercise testing protocol [35]. This protocol maintains a constant speed during the test and progressively increases treadmill inclination (grade) until exhaustion. In contrast, walking efficiency will be evaluated using a submaximal exercise test (performed prior to the VO2max test). This submaximal exercise test will require participants to walk on a treadmill at a self-selected pace, during which time VO2 will be recorded.
Resting Cardiovascular Function
Time frame: Pre - Post 12 weeks
Cardiovascular function will be quantified by resting blood pressure, heart rate, heart rate variability (HRV) and carotid-femoral pulse wave velocity (cfPWV). Blood pressure and heart rate will first be collected in the seated position using a manual sphygmomanometer according to the World Health Organization (WHO) recommendations. Next, heart rate will be recorded for approximately 10 minutes in the supine position, which will be used for assessment of HRV. During this collection period, participants will breathe at a rate of approximately 7 breaths per minute, which will be maintained using a metronome. The ECG data collected during this ten-minute period will then be analyzed using time domain HRV analysis and spectral HRV analysis. Lastly, cfPWV will be collected using applanation tonometry.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Pre - Post 12 weeks
Subscales for pain, stiffness and physical function will be used to assess knee osteoarthritis symptomatic burden. The WOMAC includes a total of 24 items with subscales of pain (five items), stiffness (two items), and function (17 items), which are all rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total WOMAC score will be calculated (score range of 0- 96 [no to extreme problems]), as well as the pain (score 0- 20), stiffness (score 0- 8), and function (score 0- 68) subscales.
Physical function
Time frame: Pre - Post 12 weeks
The 6-minute walk test (6MWT)
Balance
Time frame: Pre - Post 12 weeks
Single leg stance time (the ability to stand on one limb unassisted) will be recorded in seconds (maximum time = 30 seconds) [43]. Three trials will be completed using an AMTI force platform (AMTI OPT464508HF sampling at 1000Hz; AMTI, USA) to assess postural balance control in quiet bipedal stance. Participants will stand as still as possible in a relaxed upright position with their feet parallel on predetermined marks (10 cm apart) and with their arms hanging against the thighs. Center of pressure displacement will be measured under two conditions: 1) eyes open; and 2) eyes closed. In the eyes open condition, participants will be asked to look at a target 2.5 m in front of them. In the eyes closed condition, a blindfold will be used to assure the absence of visual feedback.
Muscle Strength
Time frame: Pre - Post 12 weeks
A Biodex isokinetic dynamometer (Biodex, Corp., Shirley, NY) will be used to measure the isometric strength of knee flexors and extensors.
Body Composition
Time frame: Pre - Post 12 weeks
Whole-body and appendicular body (i.e., arms and legs) composition parameters including total fat mass, fat-free mass, body fat percent, and bioelectrical impedance (lower-body segmental extracellular and intracellular water content, resistance, reactance) will be performed throughout the intervention to assess tissue level improvements in body composition components specific to the desired outcomes of the intervention.
Fasting Blood Glucose
Time frame: Pre - Post 12 weeks
FBG will be collected at baseline prior to the intervention and again at weeks 6 and 12. For measurements of FBG, participants will arrive at the laboratory after an overnight fast from food (≥ 8 hours) and abstention from exercise (≥ 12 hour). Upon arrival, participants FBG will be collected from capillary blood using a standard glucometer (KetoMojo, Napa, California, USA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Derived from this study: PubMed 42028108Oliveira N, Stavres J, Chiu CY, Graybeal AJ. Effects of a 12-week increased hip flexion gait exercise intervention in individuals with obesity and knee osteoarthritis: a randomized crossover feasibility study. Front Sports Act Living. 2026 Apr 8;8:1791400. doi: 10.3389/fspor.2026.1791400. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HFFS in people with Osteoarthritis, Knee and Obesity, run by University of Southern Mississippi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nuno Oliveira, PhD (601-266-5804, nuno.oliveira@usm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Fitness (time frame: Pre - Post 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05997862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.