NCT06612372

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

September 25, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

September 19, 2024

Last Update Submit

September 24, 2024

Conditions

Cartilage DegenerationWeightlessness

Outcome Measures

Primary Outcomes (1)

  • T2 mapping

    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 Outcomes (2)

  • Y-balance test

    three days before the HDBR started and three days after the HDBR ended

  • International Knee Documentation Committee (IKDC) scores

    three days before the HDBR started and three days after the HDBR ended

Study Arms (1)

Long term bed rest intervention group

EXPERIMENTAL

60-day-6° head-down bed rest

Behavioral: 60-day-6° head-down bed rest

Interventions

60-day-6° head-down bed restBEHAVIORAL

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

Long term bed rest intervention group

Eligibility Criteria

Age25 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

Study Officials

  • Jianquan Wang, M.D.

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Jianquan Wang, M.D.

CONTACT

13253137009wjqsportsmed@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 25, 2024

Study Start

September 10, 2023

Primary Completion

November 10, 2024

Study Completion

November 15, 2024

Last Updated

September 25, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)