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NCT Number: NCT06612372

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

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.

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Key information

Age range

25 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, China

Location status: Recruiting

Location contact

Jian-quan Wang, M.D.

CONTACT

[email protected]

13801076267

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

60-day-6° head-down bed rest

Behavioral

Throughout the bed rest period, subjects carried out all activities of daily living-eating, voiding, recreation, and testing

Primary outcomes

  1. T2 mapping

    Time frame: 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 outcomes

  1. Y-balance test

    Time frame: 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.

  2. International Knee Documentation Committee (IKDC) scores

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianquan Wang, M.D.

CONTACT

[email protected]

13253137009

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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