Clinical trial NCT03973463: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Obesity
Diet, Healthy
Training Group, Sensitivity
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: WOMAC
timeFrame: Baseline and after 3 months
measure: KOOS
timeFrame: Baseline and after 3 months
measure: Body fat percentage
timeFrame: Baseline and after 3 months
measure: Body Mass Index
timeFrame: Baseline and after 3 months
measure: waistline
timeFrame: Baseline and after 3 months
Secondary outcomes:
measure: hand grip force measurement
timeFrame: Baseline and 3 months
measure: 2.44m time up to go
timeFrame: Baseline and 3 months
measure: 30 chair stand test
timeFrame: Baseline and 3 months
measure: total cholesterol
timeFrame: Baseline and 3 months
measure: Low-density cholesterol
timeFrame: Baseline and 3 months
measure: triglyceride
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: Chang Gung Medical Foundation
state: Republic OF China
Study officials:
affiliation: Chang Gung Medical Foundation
name: YEN-I HSU
role: STUDY_DIRECTOR
References: