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

September 24, 2024 updated by: Peking University Third Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long term bed rest intervention group
60-day-6° head-down bed rest
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
three days before the HDBR started and three days after the HDBR ended

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
reflects the highest level of activity that an individual is able to perform.
three days before the HDBR started and three days after the HDBR ended

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Study Chair: Jianquan Wang, M.D., Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2023

Primary Completion (Estimated)

November 10, 2024

Study Completion (Estimated)

November 15, 2024

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • M2024710

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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