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Recruiting NCT06612372

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

No phase Interventional Cartilage Degeneration Weightlessness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 60-day-6° head-down bed rest.
Who it may be relevant to
Registry conditions: Cartilage Degeneration, Weightlessness. Basic parameters: 25 years — 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 60-day-6° head-down bed rest
    Throughout the bed rest period, subjects carried out all activities of daily living-eating, voiding, recreation, and testing

Primary outcome measures

  • T2 mapping [Time frame: three days before the HDBR started and three days after the HDBR ended]
Secondary outcome measures (2)
  • Y-balance test [Time frame: three days before the HDBR started and three days after the HDBR ended]
  • International Knee Documentation Committee (IKDC) scores [Time frame: three days before the HDBR started and three days after the HDBR ended]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • Peking University Third Hospital — Beijing

Identifiers

NCT: NCT06612372 · M2024710

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗