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

NCT ID: NCT06612372

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-10

Study Completion Date

2024-11-15

Brief Summary

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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

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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.

Conditions

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Cartilage Degeneration Weightlessness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Long term bed rest intervention group

60-day-6° head-down bed rest

Group Type EXPERIMENTAL

60-day-6° head-down bed rest

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianquan Wang, M.D.

Role: STUDY_CHAIR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianquan Wang, M.D.

Role: CONTACT

13253137009

Facility Contacts

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Jian-quan Wang, M.D.

Role: primary

13801076267

Other Identifiers

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M2024710

Identifier Type: -

Identifier Source: org_study_id

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