Calorie Restricted Diet and Exercise

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05092178
• Other study ID #: exercise01
• Status: Completed
• Phase: N/A
• Start date: January 6, 2019
• Est. completion date: November 20, 2022

Study information

• Verified date: December 2022
• Source: The First People's Hospital of Jingzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 20, 2022
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• calorie restricted diet and exercise
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 alone
In exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Jingzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	systolic blood pressure change	systolic blood pressure /mmHg	Change from Baseline systolic blood pressure at 6 months
Secondary	systolic blood pressure change	systolic blood pressure /mmHg	Change from Baseline systolic blood pressure at 12 months
Secondary	diastolic blood pressure change	diastolic blood pressure/mmHg	Change from Baseline diastolic blood pressure at 6 months
Secondary	diastolic blood pressure change	diastolic blood pressure/mmHg	Change from Baseline diastolic blood pressure at 12 months
Secondary	body mass index change	body mass index /kg/?	Change from Baseline body mass index at 6 months
Secondary	body mass index change	body mass index /kg/?	Change from Baseline body mass index at 12 months
Secondary	weight change	Weight-kg	Change from Baseline weight at 6 months
Secondary	weight change	Weight-kg	Change from Baseline weight at 12 months
Secondary	high-density lipoprotein cholesterol change	high-density lipoprotein cholesterol (mmol/L)	Change from Baseline high-density lipoprotein cholesterol at 6 months
Secondary	high-density lipoprotein cholesterol change	high-density lipoprotein cholesterol (mmol/L)	Change from Baseline high-density lipoprotein cholesterol at 12 months
Secondary	low-density lipoprotein cholesterol change	low-density lipoprotein cholesterol (mmol/L)	Change from Baseline low-density lipoprotein cholesterol at 6 months
Secondary	low-density lipoprotein cholesterol change	low-density lipoprotein cholesterol (mmol/L)	Change from Baseline low-density lipoprotein cholesterol at 12 months
Secondary	triglycerides change	triglycerides (mmol/l)	Change from Baseline triglycerides at 6 months
Secondary	triglycerides change	triglycerides (mmol/l)	Change from Baseline triglycerides at 12 months
Secondary	total cholesterol change	total cholesterol (mmol/L)	Change from Baseline total cholesterol at 6 months
Secondary	total cholesterol change	total cholesterol (mmol/L)	Change from Baseline total cholesterol at 12 months
Secondary	fast blood glucose change	fast blood glucose (mmol/L)	Change from Baseline fast blood glucose at 6 months
Secondary	fast blood glucose change	fast blood glucose (mmol/L)	Change from Baseline fast blood glucose at 12 months
Secondary	waist circumstance change	waist circumstance (cm)	Change from Baseline waist circumstance at 6 months
Secondary	waist circumstance change	waist circumstance (cm)	Change from Baseline waist circumstance at 12 months