Effects of 60-day-6° Head-down Bed Rest on Cartilage and Function of the Knee Joint

Not Applicable

Recruiting

• Conditions: Cartilage Degeneration; Weightlessness
• Interventions: Behavioral: 60-day-6° head-down bed rest

• Registration Number: NCT06612372
• Lead Sponsor: Peking University Third Hospital

Brief Summary

Objective: To investigate the effects of long-term simulated unloading in bed on articular cartilage quality based on functional magnetic resonance imaging (FMRI) and Knee joint function.

Detailed Description

A total of 26 subjects were recruited for a 60-day period of head-down bed rest (HDBR). The bed rest position is a 6° downward tilt of the head, and all daily activities are performed in this position. We will perform functional MRI scans of the right knee joint using T2 mapping sequences to assess tissue composition and water content before and after HDBR. Functional assessments, including the Y-Balance Test and International Knee Documentation Committee (IKDC) scores, were performed pre-HDBR and post-HDBR.We will divide each participant's knee cartilage into 18 regions and measured T2 values according to the whole organ magnetic resonance imaging score (WORMS) partitioning method.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-09-10
• Status Verified: 2024-08
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-24
• Last Update Submitted: 2024-09-24
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25
• Primary Completion: 2024-11-10
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 26

Inclusion Criteria

• (1) male; (2) age 25-50 years old; (3) height between 160-175 cm, weight ≥50kg, and BMI between 18.5-26 kg/m²; (4) good general health status.

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Exclusion Criteria

• (1) history of alcoholism; (2) smoking ≥5 cigarettes/day in the 3 months before the test; (3) drug dependence or use of medications affecting bone metabolism within 2 weeks before screening; (4) presence of metal implants, severe vertigo, or severe snoring.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Long term bed rest intervention group	60-day-6° head-down bed rest	60-day-6° head-down bed rest

Primary Outcome Measures

Name	Time	Method
T2 mapping	three days before the HDBR started and three days after the HDBR ended	metabolic and microstructural changes within the articular cartilage matrix components can be assessed, reflecting collagen fiber structure integrity and water content within the tissue

Secondary Outcome Measures

Name	Time	Method
Y-balance test	three days before the HDBR started and three days after the HDBR ended	can comprehensively evaluate an individual's joint range of motion, lower limb strength, sense of balance, and neuromuscular control, as well as the postural control and dynamic stability of lower limbs.
International Knee Documentation Committee (IKDC) scores	three days before the HDBR started and three days after the HDBR ended	reflects the highest level of activity that an individual is able to perform.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China