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Effects of Diet Control and Resistance Exercise Training on Obesity Adults With Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee, Obesity, Diet, Healthy

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Elastic knee joint movement
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cases of knee joint degeneration diagnosed by orthopedics, rheumatology and immunology physicians.
  • X-ray interpretation (kellgren & Lawrence grade) grades 1 to 3 or mild to moderate patients.
  • Willing to sign written consent form.
  • Pain Index (VAS) ≧ 4/10.
  • Men and women over the age of 55.
  • Body mass index (BMI) ≧ 27 kg/m^2.

Exclusion Criteria:

  • Unable to act on your own.
  • X-ray interpretation (kellgren & Lawrence level) is greater than level 3 or is a serious level.
  • Patients who have undergone knee arthroplasty on one or both feet.
  • Patients with terminal liver and kidney disease.
  • Those who are unable to perform physical function measurement after severe diagnosis of heart and lung disease after diagnosis by the physician.
  • High blood pressure with poor control (systolic blood pressure greater than or equal to 180 mmHg at the time of return).
  • Pregnant women or breastfeeding women.
  • Those who have coronary stents, cardiac rhythms, or other metallic substances in the body are not recommended for total body composition analysis.
  • Those with severe hip, knee, and lower back pain who are unable to perform exercise, other neuromuscular, skeletal joints, or rheumatic diseases may be exacerbated by exercise. Or those who have musculoskeletal injuries in the past six months (such as bruises, fractures, etc.).
  • Unable to cooperate with the test or halfway through the test.

Sites / Locations

  • Chang Gung Medical FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Low fat diet,12 weeks low oil balance 1200 kcal / day

12-week resistance exercise 3 times a week

12 weeks low oil balance and resistance exercise

Arm Description

12 weeks low oil balance 1200 kcal / day

12-week stretch with resistance exercise, 3 times a week

12 weeks low oil balance 1200 kcal / day and 12-week stretch with resistance exercise, 3 times a week

Outcomes

Primary Outcome Measures

WOMAC
WOMAC is used to measure the patient's home knee function. Each question is scored using a five-point scale. The higher the score, the worse the knee function. This study assessed the amount of change in WOMAC scores, whether it was lower than baseline after 12 weeks.
KOOS
KOOS is based on WOMAC and covers a wider range. The score of each topic is 0-4 points. The higher the score after the conversion formula, the better the knee joint function. This study assessed changes in KOOS scores, whether it was higher than baseline after 12 weeks.
Body fat percentage
Assess the amount of body fat (%) change, whether it can be less than baseline after 12 weeks
Body Mass Index
Assess the amount of Body Mass Index(kg/m^2) change, whether it can be less than baseline after 12 weeks
waistline
Waist circumference change from baseline to 12 weeks (cm)

Secondary Outcome Measures

hand grip force measurement
Easy to stand. Used to grasp the grip
2.44m time up to go
Stand up when you hear the start password. Use the brisk walk to bypass the marker point and then return to the chair to sit down.
30 chair stand test
Sit down and stand up to stand upright, then quickly return to sit down for an action, within 30 seconds
total cholesterol
Cases will be tested for total cholesterol (mg/dL) in routine outpatient care. This study, at baseline and 12 weeks later, copied the most recent total cholesterol report from the case. The amount of change in total cholesterol after baseline and 12 weeks was compared.
Low-density cholesterol
Cases in the outpatient routine care will be blood tests for low-density cholesterol (LDL-C, mg / dL), the study of the most recent low-density cholesterol report from the case at baseline and 12 weeks later, compared with baseline and 12 weeks later Low-density cholesterol has changed.
triglyceride
Cases will be tested for triglycerides (mg/dL) in routine outpatient care. In the study, at the baseline and after 12 weeks, the most recent triglyceride report from the case was copied. The amount of change in triglyceride at baseline and after 12 weeks was compared.

Full Information

First Posted
May 30, 2019
Last Updated
August 4, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03973463
Brief Title
Effects of Diet Control and Resistance Exercise Training on Obesity Adults With Knee Osteoarthritis
Official Title
Effects of Diet Control and Resistance Exercise Training on Obesity Adults With Knee Osteoarthritis in Pain Relief, Body Composition, Lower Limb Function and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study was to investigate the effects of obesity on knee degenerative arthritis on body composition after dietary control and elastic resistance exercise; and whether persistent exercise habits and dietary control can relieve pain and strengthen muscle strength. Improve the quality of life and the decline of other risk factors.
Detailed Description
Due to dietary westernization and overweight, the number of knee joint degeneration is increasing year by year. Degeneration of knee arthritis can lead to pain and not exercise, and thus other chronic diseases. When the weight loss exceeds 5.1%, the function of the knee joint can be significantly improved and low heat weight loss (1200 kcal / day) and very low heat weight loss (less than 800 kcal / day) both weight loss The results are equally good .Many studies have shown that early and mid-interventional resistance exercise can improve muscle weakness, pain and stiffness in patients with degenerative knee arthritis, and elastic resistance exercise can effectively improve lower limb function and increase physical activity in patients with knee arthritis However, there has been no research on the effects of diet control and resistance exercise training on pain relief, body composition, lower limb function and quality of life in obese knee degenerative arthritis. The purpose of this study was to explore the degenerative knee degeneration. The effect of arthritis on the composition of the body after a balanced diet calorie control and home-based low-intensity elastic resistance movement; and whether persistent exercise habits and diet control can relieve pain, strengthen muscle strength, improve quality of life and other risks The effect of factor decline. Expected to combine the diet control and home group exercise to improve the quality of life of patients with degenerative knee arthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Obesity, Diet, Healthy, Training Group, Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low fat diet,12 weeks low oil balance 1200 kcal / day
Arm Type
Sham Comparator
Arm Description
12 weeks low oil balance 1200 kcal / day
Arm Title
12-week resistance exercise 3 times a week
Arm Type
Experimental
Arm Description
12-week stretch with resistance exercise, 3 times a week
Arm Title
12 weeks low oil balance and resistance exercise
Arm Type
Experimental
Arm Description
12 weeks low oil balance 1200 kcal / day and 12-week stretch with resistance exercise, 3 times a week
Intervention Type
Behavioral
Intervention Name(s)
Elastic knee joint movement
Other Intervention Name(s)
Low oil balanced diet 1200 kcal / day
Intervention Description
Low resistance (7kg and 10kg) elastic band exercise 3 times a week for 12 weeks.Balanced diet reduces oil intake by 1200 calories per day. Maintains 12 weeks.Balanced diet reduces oil intake by 1200 calories per day. Maintains 12 weeks.
Primary Outcome Measure Information:
Title
WOMAC
Description
WOMAC is used to measure the patient's home knee function. Each question is scored using a five-point scale. The higher the score, the worse the knee function. This study assessed the amount of change in WOMAC scores, whether it was lower than baseline after 12 weeks.
Time Frame
Baseline and after 3 months
Title
KOOS
Description
KOOS is based on WOMAC and covers a wider range. The score of each topic is 0-4 points. The higher the score after the conversion formula, the better the knee joint function. This study assessed changes in KOOS scores, whether it was higher than baseline after 12 weeks.
Time Frame
Baseline and after 3 months
Title
Body fat percentage
Description
Assess the amount of body fat (%) change, whether it can be less than baseline after 12 weeks
Time Frame
Baseline and after 3 months
Title
Body Mass Index
Description
Assess the amount of Body Mass Index(kg/m^2) change, whether it can be less than baseline after 12 weeks
Time Frame
Baseline and after 3 months
Title
waistline
Description
Waist circumference change from baseline to 12 weeks (cm)
Time Frame
Baseline and after 3 months
Secondary Outcome Measure Information:
Title
hand grip force measurement
Description
Easy to stand. Used to grasp the grip
Time Frame
Baseline and 3 months
Title
2.44m time up to go
Description
Stand up when you hear the start password. Use the brisk walk to bypass the marker point and then return to the chair to sit down.
Time Frame
Baseline and 3 months
Title
30 chair stand test
Description
Sit down and stand up to stand upright, then quickly return to sit down for an action, within 30 seconds
Time Frame
Baseline and 3 months
Title
total cholesterol
Description
Cases will be tested for total cholesterol (mg/dL) in routine outpatient care. This study, at baseline and 12 weeks later, copied the most recent total cholesterol report from the case. The amount of change in total cholesterol after baseline and 12 weeks was compared.
Time Frame
Baseline and 3 months
Title
Low-density cholesterol
Description
Cases in the outpatient routine care will be blood tests for low-density cholesterol (LDL-C, mg / dL), the study of the most recent low-density cholesterol report from the case at baseline and 12 weeks later, compared with baseline and 12 weeks later Low-density cholesterol has changed.
Time Frame
Baseline and 3 months
Title
triglyceride
Description
Cases will be tested for triglycerides (mg/dL) in routine outpatient care. In the study, at the baseline and after 12 weeks, the most recent triglyceride report from the case was copied. The amount of change in triglyceride at baseline and after 12 weeks was compared.
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cases of knee joint degeneration diagnosed by orthopedics, rheumatology and immunology physicians. X-ray interpretation (kellgren & Lawrence grade) grades 1 to 3 or mild to moderate patients. Willing to sign written consent form. Pain Index (VAS) ≧ 4/10. Men and women over the age of 55. Body mass index (BMI) ≧ 27 kg/m^2. Exclusion Criteria: Unable to act on your own. X-ray interpretation (kellgren & Lawrence level) is greater than level 3 or is a serious level. Patients who have undergone knee arthroplasty on one or both feet. Patients with terminal liver and kidney disease. Those who are unable to perform physical function measurement after severe diagnosis of heart and lung disease after diagnosis by the physician. High blood pressure with poor control (systolic blood pressure greater than or equal to 180 mmHg at the time of return). Pregnant women or breastfeeding women. Those who have coronary stents, cardiac rhythms, or other metallic substances in the body are not recommended for total body composition analysis. Those with severe hip, knee, and lower back pain who are unable to perform exercise, other neuromuscular, skeletal joints, or rheumatic diseases may be exacerbated by exercise. Or those who have musculoskeletal injuries in the past six months (such as bruises, fractures, etc.). Unable to cooperate with the test or halfway through the test.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YEN-I HSU
Phone
07-7317123
Ext
8436
Email
yenyen0411@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YEN-I HSU
Organizational Affiliation
Chang Gung Medical Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Chang Gung Medical Foundation
City
Taipei, Taiwan
State/Province
Republic OF China
ZIP/Postal Code
10507
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shui tseng
Phone
03-3196200
Ext
3706
Email
tsengshui@cgmh.org.tw

12. IPD Sharing Statement

Learn more about this trial

Effects of Diet Control and Resistance Exercise Training on Obesity Adults With Knee Osteoarthritis

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