Metabolic SyndromeNCT05092178
Calorie Restricted Diet and Exercise
A study testing calorie restricted diet and exercise and exercise alone in people with Metabolic Syndrome, run by The First People's Hospital of Jingzhou at 1 site in China.
Trial summary
Calorie-restricted(CR) diet and exercise were effective to reduce Metabolic syndrome(MetS), however, its effect on knee functions for MetS patients with degenerate meniscus lesions(DMLs) was still poorly investigated. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- calorie restricted diet and exercise and exercise alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2019to 20 Nov 2022
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Must be age between 35 and 70 years old;
- Clinical diagnosis of metabolic syndrome;
Who cannot join
- • Must be able to have no acute knee injury such as car crash or acute sports injury;
- Must be able to have no knee surgeries history;
- Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity;
- Must be able to have no contraindications to MRI;
- Must be able to have no severe cardiopulmonary disease;
- Must be able to have no musculoskeletal or neuromuscular impairments ;
- Must be able to have good visual, hearing, or cognitive;
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121000
About this study
Official title: Effect of Calorie-restricted Diet and Exercise Intervention vs Exercise on the Knee Function of Metabolic Syndrome Patients With Degenerate Meniscus Lesions, a Randomized Controlled Study
Calorie-restricted(CR) diet and exercise were effective to reduce Metabolic syndrome(MetS), however, its effect on knee functions for MetS patients with degenerate meniscus lesions(DMLs) was still poorly investigated.
Read the detailed description
The CR diet and exercise group received a balanced diet with an energy consists carbohydrates 45-65%; fat 20-35%; and protein 10- 35% and a deficit of 600 kcal/day from their daily energy requirement. Total daily energy intake of 1200-2000 kcal/day were based on baseline weight, and for safety, no woman was provided with less than 1100 kcals/d and no man less than 1300 kcals/d. The energy of the intake calorie restricted diet per day was calculated based on the detailed composition of meals, such as rice, vegetables, eggs, pork, and beef, using the Chinese food composition tables. Our diets were cooked with traditional Chinese cooking methods such as boiling, stir-frying, and stewing. During the intervention, other lipid-lowering drugs were not allowed to intake supplement as it alters the outcome. Participants receive education or counseling by a dietitian for modulations of their caloric intake weekly.
The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months. The aerobic exercises included walking on a treadmill, stationary cycling for at least 30 minutes for≥2 d/week. Resistance exercises included nine upper-extremity and lower-extremity exercise with weighting lift machines for ≥2 d/week, while, flexibility exercise including the major muscle-tendon groups (a total of 60 s per exercise) for ≥2 d/week. Participants performed 1 or 2 sets with 8-12 repetitions of each exercise. The exercise sessions were monitored by telephone video. Patients who complete at least 80% of diet restriction and exercise were included in analysis. Calorie restricted diet and exercise group contain both the above intervention.
- Conditions
- Metabolic Syndrome
- Being tested
- calorie restricted diet and exercise, exercise alone
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calorie restricted diet and exerciseBehavioural
The CR diet and exercise group received a balanced diet with an energy consists carbohydrates 45-65%; fat 20-35%; and protein 10- 35% and a deficit of 600 kcal/day from their daily energy requirement.The exercise intervention consists of aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for≥2 d•wk for six months. The aerobic exercises included walking on a treadmill, stationary cycling for at least 30 minutes for≥2 d•wk, while, resistance exercises included nine upper-extremity and lower-extremity exercise with weighting lift machines for ≥2 d•wk, while, flexibility exercise including the major muscle-tendon groups (a total of 60 s per exercise) for ≥2 d•wk. Participants performed 1 or 2 sets with 8-12 repetitions of each exercise. The exercise sessions were monitored by telephone video.
exercise aloneBehavioural
In exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program.
| Study group | Role | What they receive |
|---|---|---|
| Calorie restricted diet and exercise intervention | Experimental | The CR diet and exercise group received a balanced diet with an energy consists carbohydrates 45-65%; fat 20-35%; and protein 10- 35% and a deficit of 600 kcal/day from their daily energy requirement.
The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months. Receives: Behavioral: calorie restricted diet and exercise |
| exercise group | Active comparator | In exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program. Receives: Behavioral: exercise alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Knee injury and Osteoarthritis Outcome Score (KOOS) score change
The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
Measured: Change from Baseline KOOS at 6 months
The International Knee Documentation Committee Subjective Knee Evaluation score change
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.
Measured: Change from Baseline IKDC at 6 months
The Knee injury and Osteoarthritis Outcome Score (KOOS) score change
The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
Measured: Change from Baseline KOOS at 12 months
The International Knee Documentation Committee Subjective Knee Evaluation score change
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.
Measured: Change from Baseline IKDC at 12 months
Secondary outcomes (30)
subscales of KOOS pain score change
Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life.The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: Change from Baseline pain at 6 months
subscales of KOOS pain score change
Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life.The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: Change from Baseline pain at 12 months
subscales of KOOS symptoms score change
Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life. The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: Change from Baseline symptoms at 6 months
subscales of KOOS symptoms score change
Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life. The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: Change from Baseline symptoms at 12 months
KOOS activity of daily living change
Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life. The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: Change from Baseline activity of daily living at 6 months
KOOS activity of daily living change
Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life. The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: Change from Baseline activity of daily living at 12 months
sport and recreational function change
Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life. The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: Change from Baseline sport and recreational function at 6 months
sport and recreational function change
Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life. The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: Change from Baseline sport and recreational function at 12 months
knee related quality of life change
Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life. The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: Change from Baseline knee related quality of life at 6 months
knee related quality of life change
Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life. The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.
Measured: Change from Baseline knee related quality of life at 12 months
systolic blood pressure change
systolic blood pressure /mmHg
Measured: Change from Baseline systolic blood pressure at 6 months
systolic blood pressure change
systolic blood pressure /mmHg
Measured: Change from Baseline systolic blood pressure at 12 months
diastolic blood pressure change
diastolic blood pressure/mmHg
Measured: Change from Baseline diastolic blood pressure at 6 months
diastolic blood pressure change
diastolic blood pressure/mmHg
Measured: Change from Baseline diastolic blood pressure at 12 months
body mass index change
body mass index /kg/㎡
Measured: Change from Baseline body mass index at 6 months
body mass index change
body mass index /kg/㎡
Measured: Change from Baseline body mass index at 12 months
weight change
Weight-kg
Measured: Change from Baseline weight at 6 months
weight change
Weight-kg
Measured: Change from Baseline weight at 12 months
high-density lipoprotein cholesterol change
high-density lipoprotein cholesterol (mmol/L)
Measured: Change from Baseline high-density lipoprotein cholesterol at 6 months
high-density lipoprotein cholesterol change
high-density lipoprotein cholesterol (mmol/L)
Measured: Change from Baseline high-density lipoprotein cholesterol at 12 months
low-density lipoprotein cholesterol change
low-density lipoprotein cholesterol (mmol/L)
Measured: Change from Baseline low-density lipoprotein cholesterol at 6 months
low-density lipoprotein cholesterol change
low-density lipoprotein cholesterol (mmol/L)
Measured: Change from Baseline low-density lipoprotein cholesterol at 12 months
triglycerides change
triglycerides (mmol/l)
Measured: Change from Baseline triglycerides at 6 months
triglycerides change
triglycerides (mmol/l)
Measured: Change from Baseline triglycerides at 12 months
total cholesterol change
total cholesterol (mmol/L)
Measured: Change from Baseline total cholesterol at 6 months
total cholesterol change
total cholesterol (mmol/L)
Measured: Change from Baseline total cholesterol at 12 months
fast blood glucose change
fast blood glucose (mmol/L)
Measured: Change from Baseline fast blood glucose at 6 months
fast blood glucose change
fast blood glucose (mmol/L)
Measured: Change from Baseline fast blood glucose at 12 months
waist circumstance change
waist circumstance (cm)
Measured: Change from Baseline waist circumstance at 6 months
waist circumstance change
waist circumstance (cm)
Measured: Change from Baseline waist circumstance at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start6 Jan 2019
- Primary completion4 Nov 2021
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Jingzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyu Wang, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092178
- Sponsor's protocol ID
- exercise01
- Status last verified
- Dec 2022
- First submitted
- 13 Oct 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calorie-restricted Diet and Exercise Intervention vs Exercise on the Knee Function of Metabolic Syndrome Patients With Degenerate Meniscus Lesions, a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05092178
- Acronym / sponsor ID
- exercise01
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- The First People's Hospital of JingzhouUniversity, hospital or other
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 25 Oct 2021 (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.
Calorie-restricted(CR) diet and exercise were effective to reduce Metabolic syndrome(MetS), however, its effect on knee functions for MetS patients with degenerate meniscus lesions(DMLs) was still poorly investigated.
Detailed description
The CR diet and exercise group received a balanced diet with an energy consists carbohydrates 45-65%; fat 20-35%; and protein 10- 35% and a deficit of 600 kcal/day from their daily energy requirement. Total daily energy intake of 1200-2000 kcal/day were based on baseline weight, and for safety, no woman was provided with less than 1100 kcals/d and no man less than 1300 kcals/d. The energy of the intake calorie restricted diet per day was calculated based on the detailed composition of meals, such as rice, vegetables, eggs, pork, and beef, using the Chinese food composition tables. Our diets were cooked with traditional Chinese cooking methods such as boiling, stir-frying, and stewing. During the intervention, other lipid-lowering drugs were not allowed to intake supplement as it alters the outcome. Participants receive education or counseling by a dietitian for modulations of their caloric intake weekly.
The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months. The aerobic exercises included walking on a treadmill, stationary cycling for at least 30 minutes for≥2 d/week. Resistance exercises included nine upper-extremity and lower-extremity exercise with weighting lift machines for ≥2 d/week, while, flexibility exercise including the major muscle-tendon groups (a total of 60 s per exercise) for ≥2 d/week. Participants performed 1 or 2 sets with 8-12 repetitions of each exercise. The exercise sessions were monitored by telephone video. Patients who complete at least 80% of diet restriction and exercise were included in analysis. Calorie restricted diet and exercise group contain both the above intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calorie restricted diet and exercise intervention | Experimental | Behavioral: calorie restricted diet and exerciseThe CR diet and exercise group received a balanced diet with an energy consists carbohydrates 45-65%; fat 20-35%; and protein 10- 35% and a deficit of 600 kcal/day from their daily energy requirement. The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months. |
| exercise group | Active comparator | Behavioral: exercise aloneIn exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Must be age between 35 and 70 years old;
Key exclusion criteria (7 listed)
- • Must be able to have no acute knee injury such as car crash or acute sports injury;
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 |
|---|---|---|
| calorie restricted diet and exerciseThe CR diet and exercise group received a balanced diet with an energy consists carbohydrates 45-65%; fat 20-35%; and protein 10- 35% and a deficit of 600 kcal/day from their daily energy requirement.The exercise intervention consists of aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for≥2 d•wk for six months. The aerobic exercises included walking on a treadmill, stationary cycling for at least 30 minutes for≥2 d•wk, while, resistance exercises included nine upper-extremity and lower-extremity exercise with weighting lift machines for ≥2 d•wk, while, flexibility exercise including the major muscle-tendon groups (a total of 60 s per exercise) for ≥2 d•wk. Participants performed 1 or 2 sets with 8-12 repetitions of each exercise. The exercise sessions were monitored by telephone video. | Behavioural | Calorie restricted diet and exercise intervention |
| exercise aloneIn exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program. | Behavioural | exercise group |
Primary outcome
The Knee injury and Osteoarthritis Outcome Score (KOOS) score change
Time frame: Change from Baseline KOOS at 6 months
The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
The International Knee Documentation Committee Subjective Knee Evaluation score change
Time frame: Change from Baseline IKDC at 6 months
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.
The Knee injury and Osteoarthritis Outcome Score (KOOS) score change
Time frame: Change from Baseline KOOS at 12 months
The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
The International Knee Documentation Committee Subjective Knee Evaluation score change
Time frame: Change from Baseline IKDC at 12 months
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.
30 secondary outcomes
subscales of KOOS pain score change
Time frame: Change from Baseline pain at 6 months
subscales of KOOS pain score change
Time frame: Change from Baseline pain at 12 months
subscales of KOOS symptoms score change
Time frame: Change from Baseline symptoms at 6 months
subscales of KOOS symptoms score change
Time frame: Change from Baseline symptoms at 12 months
KOOS activity of daily living change
Time frame: Change from Baseline activity of daily living at 6 months
KOOS activity of daily living change
Time frame: Change from Baseline activity of daily living at 12 months
sport and recreational function change
Time frame: Change from Baseline sport and recreational function at 6 months
sport and recreational function change
Time frame: Change from Baseline sport and recreational function at 12 months
knee related quality of life change
Time frame: Change from Baseline knee related quality of life at 6 months
knee related quality of life change
Time frame: Change from Baseline knee related quality of life at 12 months
systolic blood pressure change
Time frame: Change from Baseline systolic blood pressure at 6 months
systolic blood pressure change
Time frame: Change from Baseline systolic blood pressure at 12 months
diastolic blood pressure change
Time frame: Change from Baseline diastolic blood pressure at 6 months
diastolic blood pressure change
Time frame: Change from Baseline diastolic blood pressure at 12 months
body mass index change
Time frame: Change from Baseline body mass index at 6 months
body mass index change
Time frame: Change from Baseline body mass index at 12 months
weight change
Time frame: Change from Baseline weight at 6 months
weight change
Time frame: Change from Baseline weight at 12 months
high-density lipoprotein cholesterol change
Time frame: Change from Baseline high-density lipoprotein cholesterol at 6 months
high-density lipoprotein cholesterol change
Time frame: Change from Baseline high-density lipoprotein cholesterol at 12 months
low-density lipoprotein cholesterol change
Time frame: Change from Baseline low-density lipoprotein cholesterol at 6 months
low-density lipoprotein cholesterol change
Time frame: Change from Baseline low-density lipoprotein cholesterol at 12 months
triglycerides change
Time frame: Change from Baseline triglycerides at 6 months
triglycerides change
Time frame: Change from Baseline triglycerides at 12 months
total cholesterol change
Time frame: Change from Baseline total cholesterol at 6 months
total cholesterol change
Time frame: Change from Baseline total cholesterol at 12 months
fast blood glucose change
Time frame: Change from Baseline fast blood glucose at 6 months
fast blood glucose change
Time frame: Change from Baseline fast blood glucose at 12 months
waist circumstance change
Time frame: Change from Baseline waist circumstance at 6 months
waist circumstance change
Time frame: Change from Baseline waist circumstance at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calorie restricted diet and exercise and exercise alone in people with Metabolic Syndrome, run by The First People's Hospital of Jingzhou at 1 site in China.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 18 Jan 2023. 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 China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Knee injury and Osteoarthritis Outcome Score (KOOS) score change (time frame: Change from Baseline KOOS at 6 months). The study lists 4 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 18 Jan 2023.