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

Primary Purpose

Osteoarthritis, Knee, Obesity

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HFFS
Sponsored by
University of Southern Mississippi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Exercise, Osteoarthritis, Obesity

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Southern MississippiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Physical function
The 6-minute walk test (6MWT)
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.
Muscle Strength
A Biodex isokinetic dynamometer (Biodex, Corp., Shirley, NY) will be used to measure the isometric strength of knee flexors and extensors.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
May 1, 2023
Last Updated
August 11, 2023
Sponsor
University of Southern Mississippi
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1. Study Identification

Unique Protocol Identification Number
NCT05997862
Brief Title
A Hip Flexion Feedback System for Exercise Monitoring in Individuals With Osteoarthritis and Obesity
Official Title
A Hip Flexion Feedback System for Exercise Monitoring in Individuals With Osteoarthritis and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Mississippi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Obesity
Keywords
Exercise, Osteoarthritis, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HFFS
Intervention Description
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 Information:
Title
Cardiorespiratory Fitness
Description
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.
Time Frame
Pre - Post 12 weeks
Title
Resting Cardiovascular Function
Description
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.
Time Frame
Pre - Post 12 weeks
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
Pre - Post 12 weeks
Title
Physical function
Description
The 6-minute walk test (6MWT)
Time Frame
Pre - Post 12 weeks
Title
Balance
Description
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.
Time Frame
Pre - Post 12 weeks
Title
Muscle Strength
Description
A Biodex isokinetic dynamometer (Biodex, Corp., Shirley, NY) will be used to measure the isometric strength of knee flexors and extensors.
Time Frame
Pre - Post 12 weeks
Title
Body Composition
Description
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.
Time Frame
Pre - Post 12 weeks
Title
Fasting Blood Glucose
Description
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).
Time Frame
Pre - Post 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuno Oliveira, PhD
Phone
601-266-5804
Email
nuno.oliveira@usm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sam Bruton
Phone
601-266-6756
Email
samuel.bruton@usm.edu
Facility Information:
Facility Name
University Southern Mississippi
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402-7326
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuno Oliveira
Phone
601-266-5804
Email
nuno.oliveira@usm.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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