Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| exercise group | Active Comparator | In exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calorie restricted diet and exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 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) | 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. | Change from Baseline IKDC at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline pain at 6 months |
Not provided
Inclusion Criteria:
• Must be age between 35 and 70 years old;
Exclusion Criteria:
• Must be able to have no acute knee injury such as car crash or acute sports injury;
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Jinzhou Medical University | Jinzhou | Liaoning | 121000 | China |
Not provided
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| exercise alone | Behavioral | In exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Change from Baseline knee related quality of life at 12 months |
| systolic blood pressure change | systolic blood pressure /mmHg | Change from Baseline systolic blood pressure at 6 months |
| systolic blood pressure change | systolic blood pressure /mmHg | Change from Baseline systolic blood pressure at 12 months |
| diastolic blood pressure change | diastolic blood pressure/mmHg | Change from Baseline diastolic blood pressure at 6 months |
| diastolic blood pressure change | diastolic blood pressure/mmHg | Change from Baseline diastolic blood pressure at 12 months |
| body mass index change | body mass index /kg/㎡ | Change from Baseline body mass index at 6 months |
| body mass index change | body mass index /kg/㎡ | Change from Baseline body mass index at 12 months |
| weight change | Weight-kg | Change from Baseline weight at 6 months |
| weight change | Weight-kg | Change from Baseline weight at 12 months |
| high-density lipoprotein cholesterol change | high-density lipoprotein cholesterol (mmol/L) | Change from Baseline high-density lipoprotein cholesterol at 6 months |
| high-density lipoprotein cholesterol change | high-density lipoprotein cholesterol (mmol/L) | Change from Baseline high-density lipoprotein cholesterol at 12 months |
| low-density lipoprotein cholesterol change | low-density lipoprotein cholesterol (mmol/L) | Change from Baseline low-density lipoprotein cholesterol at 6 months |
| low-density lipoprotein cholesterol change | low-density lipoprotein cholesterol (mmol/L) | Change from Baseline low-density lipoprotein cholesterol at 12 months |
| triglycerides change | triglycerides (mmol/l) | Change from Baseline triglycerides at 6 months |
| triglycerides change | triglycerides (mmol/l) | Change from Baseline triglycerides at 12 months |
| total cholesterol change | total cholesterol (mmol/L) | Change from Baseline total cholesterol at 6 months |
| total cholesterol change | total cholesterol (mmol/L) | Change from Baseline total cholesterol at 12 months |
| fast blood glucose change | fast blood glucose (mmol/L) | Change from Baseline fast blood glucose at 6 months |
| fast blood glucose change | fast blood glucose (mmol/L) | Change from Baseline fast blood glucose at 12 months |
| waist circumstance change | waist circumstance (cm) | Change from Baseline waist circumstance at 6 months |
| waist circumstance change | waist circumstance (cm) | Change from Baseline waist circumstance at 12 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |