Calorie Restricted Diet and Exercise

NCT05092178 | Completed DMC

• 1 other identifier: exercise01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (30)

• subscales of KOOS pain score change

  Change from Baseline pain at 6 months

• subscales of KOOS pain score change

  Change from Baseline pain at 12 months

• subscales of KOOS symptoms score change

  Change from Baseline symptoms at 6 months

• subscales of KOOS symptoms score change

  Change from Baseline symptoms at 12 months

• KOOS activity of daily living change

  Change from Baseline activity of daily living at 6 months

Study Arms (2)

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.

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.

Behavioral: exercise alone

Interventions

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.

Calorie restricted diet and exercise intervention

exercise alone BEHAVIORAL

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

exercise group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be age between 35 and 70 years old;
• Clinical diagnosis of metabolic syndrome;

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First People's Hospital of Jingzhou: lead

Study Sites (1)

First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121000, China

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Caloric Restriction; Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 25, 2021
• Study Start: January 6, 2019
• Primary Completion: November 4, 2021
• Study Completion: November 20, 2022
• Last Updated: January 18, 2023

Record last verified: 2022-12

Locations

CN (1)