Calorie Restricted Diet and Exercise

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: calorie restricted diet and exercise; Behavioral: exercise alone

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Jinzhou, Liaoning, China, 121000
      • First Affiliated Hospital of Jinzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First People's Hospital of Jingzhou

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2019
• Primary Completion (Actual): November 4, 2021
• Study Completion (Actual): November 20, 2022

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 15, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: exercise01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No