Osteoarthritis, KneeNCT03973463
Effects of Diet Control and Resistance Exercise Training on Obesity Adults With Knee Osteoarthritis
A study testing Elastic knee joint movement in people with Osteoarthritis, Knee and Obesity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Obesity, Diet, Healthy
- What is being tested?
- Elastic knee joint movement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 May 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Medical Foundation
Taipei, Taiwan, Republic of China, 10507
shui tseng, 03-3196200 ext. 3706, tsengshui@cgmh.org.tw
About this study
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
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.
Read the 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.
- Being tested
- Elastic knee joint movement
- Medical subject headings
- Osteoarthritis, Knee, Obesity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic knee joint movementBehavioural
Also called Low oil balanced diet 1200 kcal / day
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.
| Study group | Role | What they receive |
|---|---|---|
| Low fat diet,12 weeks low oil balance 1200 kcal / day | Sham comparator | 12 weeks low oil balance 1200 kcal / day Receives: Behavioral: Elastic knee joint movement |
| 12-week resistance exercise 3 times a week | Experimental | 12-week stretch with resistance exercise, 3 times a week Receives: 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 Receives: Behavioral: Elastic knee joint movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline and after 3 months
waistline
Waist circumference change from baseline to 12 weeks (cm)
Measured: Baseline and after 3 months
Secondary outcomes (6)
hand grip force measurement
Easy to stand. Used to grasp the grip
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
30 chair stand test
Sit down and stand up to stand upright, then quickly return to sit down for an action, within 30 seconds
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start3 May 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yenyen0411, Chang Gung Memorial Hospital
- Investigators
- YEN-I HSU, Study director, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973463
- Sponsor's protocol ID
- 201800607B0
- Status last verified
- Aug 2021
- First submitted
- 30 May 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03973463
- Acronym / sponsor ID
- 201800607B0
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low fat diet,12 weeks low oil balance 1200 kcal / day | Sham comparator | Behavioral: Elastic knee joint movement12 weeks low oil balance 1200 kcal / day |
| 12-week resistance exercise 3 times a week | Experimental | Behavioral: Elastic knee joint movement12-week stretch with resistance exercise, 3 times a week |
| 12 weeks low oil balance and resistance exercise | Experimental | Behavioral: Elastic knee joint movement12 weeks low oil balance 1200 kcal / day and 12-week stretch with resistance exercise, 3 times a week |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastic knee joint movementAlso: Low oil balanced diet 1200 kcal / dayLow 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. | Behavioural | 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 |
Primary outcome
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)
6 secondary outcomes
hand grip force measurement
Time frame: Baseline and 3 months
2.44m time up to go
Time frame: Baseline and 3 months
30 chair stand test
Time frame: Baseline and 3 months
total cholesterol
Time frame: Baseline and 3 months
Low-density cholesterol
Time frame: Baseline and 3 months
triglyceride
Time frame: Baseline and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YEN-I HSU study director
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic knee joint movement in people with Osteoarthritis, Knee and Obesity, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YEN-I HSU (07-7317123 ext. 8436, yenyen0411@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (time frame: Baseline and after 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.