Calorie Restricted Diet and Exercise

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: calorie restricted diet and exercise
* Behavioral: exercise alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Must be age between 35 and 70 years old; Clinical diagnosis of metabolic syndrome; Exclusion Criteria: • 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;

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calorie restricted diet and exercise intervention<br>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. | Behavioral: calorie restricted diet and exercise<br>* 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.<br>|
| Active Comparator: exercise group<br>In exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program. | Behavioral: exercise alone<br>* In exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |