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

August 4, 2021 updated by: yenyen0411, Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Republic OF China
      • Taipei, Taiwan, Republic OF China, Taiwan, 10507
        • Recruiting
        • Chang Gung Medical Foundation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • Low oil balanced diet 1200 kcal / day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 3 months
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.
Baseline and after 3 months
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
Baseline and after 3 months
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
Baseline and after 3 months
waistline
Time Frame: Baseline and after 3 months
Waist circumference change from baseline to 12 weeks (cm)
Baseline and after 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
hand grip force measurement
Time Frame: Baseline and 3 months
Easy to stand. Used to grasp the grip
Baseline and 3 months
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.
Baseline and 3 months
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
Baseline and 3 months
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.
Baseline and 3 months
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.
Baseline and 3 months
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.
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: YEN-I HSU, Chang Gung Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201800607B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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