Cartilage DegenerationNCT06612372
Effects of 60-day-6° Head-down Bed Rest on Cartilage and Function of the Knee Joint
A study testing 60-day-6° head-down bed rest in people with Cartilage Degeneration and Weightlessness, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cartilage Degeneration, Weightlessness
- What is being tested?
- 60-day-6° head-down bed rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2023to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Jian-quan Wang, M.D., 13801076267, keny1417@vip.sina.com
About this study
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.
Read the 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.
- Conditions
- Cartilage Degeneration, Weightlessness
- Being tested
- 60-day-6° head-down bed rest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60-day-6° head-down bed restBehavioural
Throughout the bed rest period, subjects carried out all activities of daily living-eating, voiding, recreation, and testing
| Study group | Role | What they receive |
|---|---|---|
| Long term bed rest intervention group | Experimental | 60-day-6° head-down bed rest Receives: Behavioral: 60-day-6° head-down bed rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three days before the HDBR started and three days after the HDBR ended
Secondary outcomes (2)
Y-balance test
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.
Measured: three days before the HDBR started and three days after the HDBR ended
International Knee Documentation Committee (IKDC) scores
reflects the highest level of activity that an individual is able to perform.
Measured: three days before the HDBR started and three days after the HDBR ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start10 Sep 2023
- Primary completion10 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DegenerationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianquan Wang, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612372
- Sponsor's protocol ID
- M2024710
- Status last verified
- Aug 2024
- First submitted
- 19 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 60-day-6° Head-down Bed Rest on Cartilage and Function of the Knee Joint
- ClinicalTrials.gov ID
- NCT06612372
- Acronym / sponsor ID
- M2024710
- Conditions
- Cartilage Degeneration, Weightlessness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 10 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long term bed rest intervention group | Experimental | Behavioral: 60-day-6° head-down bed rest60-day-6° head-down bed rest |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 60-day-6° head-down bed restThroughout the bed rest period, subjects carried out all activities of daily living-eating, voiding, recreation, and testing | Behavioural | Long term bed rest intervention group |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianquan Wang, M.D. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 60-day-6° head-down bed rest in people with Cartilage Degeneration and Weightlessness, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianquan Wang, M.D. (13253137009, wjqsportsmed@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T2 mapping (time frame: three days before the HDBR started and three days after the HDBR ended). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.