Recruiting
Phase 1
Phase 2

Exercise Monitoring

Sponsor:

University of Southern Mississippi

Code:

NCT05997862

Conditions

Osteoarthritis, Knee

Obesity

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

HFFS

Study Details

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 ID

NCT05997862

Start date

Jul 1, 2023

Status verified date

Aug, 2023

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

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.

Primary outcome measure

  • Cardiorespiratory Fitness [ Time Frame: Pre - Post 12 weeks ]
  • Resting Cardiovascular Function [ Time Frame: Pre - Post 12 weeks ]
  • The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Pre - Post 12 weeks ]
  • Physical function [ Time Frame: Pre - Post 12 weeks ]
  • Balance [ Time Frame: Pre - Post 12 weeks ]
  • Muscle Strength [ Time Frame: Pre - Post 12 weeks ]
  • Body Composition [ Time Frame: Pre - Post 12 weeks ]
  • Fasting Blood Glucose [ Time Frame: Pre - Post 12 weeks ]

Central Contacts and Locations

Central contacts

Nuno Oliveira, PhD

601-266-5804nuno.oliveira@usm.edu

Sam Bruton

601-266-6756samuel.bruton@usm.edu

Locations

University Southern Mississippi

Recruiting

Hattiesburg, Mississippi, United States, 39402-7326

Contacts

Nuno Oliveira

601-266-5804nuno.oliveira@usm.edu

More Information

Sponsor

University of Southern Mississippi

Last update posted

Aug 18, 2023

Last verified

Aug, 2023

Keywords

  • Exercise
  • Osteoarthritis
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by University of Southern Mississippi on 2023-08-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.