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

NCT03973463 | Unknown

• 1 other identifier: 201800607B0
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Obesity; Diet, Healthy; Training Group, Sensitivity

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline and after 3 months

• 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.

  Baseline and after 3 months

• Body fat percentage

  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

  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

  Waist circumference change from baseline to 12 weeks (cm)

  Baseline and after 3 months

Secondary Outcomes (6)

• hand grip force measurement

  Baseline and 3 months

• 2.44m time up to go

  Baseline and 3 months

• 30 chair stand test

  Baseline and 3 months

• total cholesterol

  Baseline and 3 months

• Low-density cholesterol

  Baseline and 3 months

Study Arms (3)

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

SHAM COMPARATOR

12 weeks low oil balance 1200 kcal / day

Behavioral: Elastic knee joint movement

12-week resistance exercise 3 times a week

EXPERIMENTAL

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

Behavioral: Elastic knee joint movement

12 weeks low oil balance and resistance exercise

EXPERIMENTAL

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

Behavioral: Elastic knee joint movement

Interventions

Elastic knee joint movement BEHAVIORAL

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.

Also known as: Low oil balanced diet 1200 kcal / day

12 weeks low oil balance and resistance exercise; 12-week resistance exercise 3 times a week; Low fat diet,12 weeks low oil balance 1200 kcal / day

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Medical Foundation

Taipei, Taiwan, Republic of China, 10507, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Obesity; Hypersensitivity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• YEN-I HSU

  Chang Gung Medical Foundation

  STUDY DIRECTOR

Central Study Contacts

YEN-I HSU

CONTACT

07-7317123; yenyen0411@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian，Investigator

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 4, 2019
• Study Start: May 3, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 5, 2021

Record last verified: 2021-08

Locations

TW (1)