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出境医 / 临床实验 / Effects of Diet Control and Resistance Exercise Training on Obesity Adults With Knee Osteoarthritis

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

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Obesity Diet, Healthy Training Group, Sensitivity Behavioral: Elastic knee joint movement Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Arm Intervention/treatment
Sham Comparator: Low fat diet,12 weeks low oil balance 1200 kcal / day
12 weeks low oil balance 1200 kcal / day
 Behavioral: Elastic knee joint movement
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.
Other Name: Low oil balanced diet 1200 kcal / day
Experimental: 12-week resistance exercise 3 times a week
12-week stretch with resistance exercise, 3 times a week
 Behavioral: Elastic knee joint movement
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.
Other Name: Low oil balanced diet 1200 kcal / day
Experimental: 12 weeks low oil balance and resistance exercise
12 weeks low oil balance 1200 kcal / day and 12-week stretch with resistance exercise, 3 times a week
 Behavioral: Elastic knee joint movement
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.
Other Name: Low oil balanced diet 1200 kcal / day
Outcome Measures
Primary Outcome Measures :
  1. WOMAC [ Time Frame: Baseline and after 3 months ]

    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.


  2. KOOS [ Time Frame: Baseline and after 3 months ]
    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.

  3. Body fat percentage [ Time Frame: Baseline and after 3 months ]
    Assess the amount of body fat (%) change, whether it can be less than baseline after 12 weeks

  4. Body Mass Index [ Time Frame: Baseline and after 3 months ]
    Assess the amount of Body Mass Index(kg/m^2) change, whether it can be less than baseline after 12 weeks

  5. waistline [ Time Frame: Baseline and after 3 months ]
    Waist circumference change from baseline to 12 weeks (cm)


Secondary Outcome Measures :
  1. hand grip force measurement [ Time Frame: Baseline and 3 months ]
    Easy to stand. Used to grasp the grip

  2. 2.44m time up to go [ Time Frame: Baseline and 3 months ]
    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.

  3. 30 chair stand test [ Time Frame: Baseline and 3 months ]
    Sit down and stand up to stand upright, then quickly return to sit down for an action, within 30 seconds

  4. total cholesterol [ Time Frame: Baseline and 3 months ]

    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.


  5. Low-density cholesterol [ Time Frame: Baseline and 3 months ]
    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.

  6. triglyceride [ Time Frame: Baseline and 3 months ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: YEN-I HSU 07-7317123 ext 8436 yenyen0411@cgmh.org.tw

Locations
Layout table for location information
Taiwan
Chang Gung Medical Foundation Recruiting
Taipei, Taiwan, Republic OF China, Taiwan, 10507
Contact: shui tseng    03-3196200 ext 3706    tsengshui@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Layout table for investigator information
Study Director: YEN-I HSU Chang Gung Medical Foundation
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE May 3, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2019)
  • WOMAC [ Time Frame: Baseline and after 3 months ]
    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 [ Time Frame: Baseline and after 3 months ]
    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 [ Time Frame: Baseline and after 3 months ]
    Assess the amount of body fat (%) change, whether it can be less than baseline after 12 weeks
  • Body Mass Index [ Time Frame: Baseline and after 3 months ]
    Assess the amount of Body Mass Index(kg/m^2) change, whether it can be less than baseline after 12 weeks
  • waistline [ Time Frame: Baseline and after 3 months ]
    Waist circumference change from baseline to 12 weeks (cm)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2019)
  • hand grip force measurement [ Time Frame: Baseline and 3 months ]
    Easy to stand. Used to grasp the grip
  • 2.44m time up to go [ Time Frame: Baseline and 3 months ]
    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 [ Time Frame: Baseline and 3 months ]
    Sit down and stand up to stand upright, then quickly return to sit down for an action, within 30 seconds
  • total cholesterol [ Time Frame: Baseline and 3 months ]
    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 [ Time Frame: Baseline and 3 months ]
    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 [ Time Frame: Baseline and 3 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Diet Control and Resistance Exercise Training on Obesity Adults With Knee Osteoarthritis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis, Knee
  • Obesity
  • Diet, Healthy
  • Training Group, Sensitivity
Intervention  ICMJE Behavioral: Elastic knee joint movement
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.
Other Name: Low oil balanced diet 1200 kcal / day
Study Arms  ICMJE
  • Sham Comparator: Low fat diet,12 weeks low oil balance 1200 kcal / day
    12 weeks low oil balance 1200 kcal / day
    Intervention: Behavioral: Elastic knee joint movement
  • Experimental: 12-week resistance exercise 3 times a week
    12-week stretch with resistance exercise, 3 times a week
    Intervention: Behavioral: Elastic knee joint movement
  • Experimental: 12 weeks low oil balance and resistance exercise
    12 weeks low oil balance 1200 kcal / day and 12-week stretch with resistance exercise, 3 times a week
    Intervention: Behavioral: Elastic knee joint movement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2019) 		90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: YEN-I HSU 07-7317123 ext 8436 yenyen0411@cgmh.org.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973463
Other Study ID Numbers  ICMJE 201800607B0
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party yenyen0411, Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: YEN-I HSU Chang Gung Medical Foundation
PRS Account Chang Gung Memorial Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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