TendinopathyTENDOTIMENCT06217432
A Study of the Effect of Time-of-day of Training on Chronic Patellar Tendinopathy
A study testing Resistance training for knee extensors in people with Tendinopathy and Jumper's Knee, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The study is a 12-week human study where 60 participants with chronic patellar tendinopathy (more than 3 months symptoms duration) are randomised to undergo 12 weeks of targeted resistance exercise either in the morning or in the late afternoon. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tendinopathy, Jumper's Knee
- What is being tested?
- Resistance training for knee extensors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Jan 2024to Dec 2025
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sports active men and women
- Age (18-55) years old
- BMI (18.5-30)
- Uni- or bilateral patellar tendinopathy
- Symptom onset >90 days ago
Who cannot join
- Patellar tendinopathy longer than 24 months
- Previous surgery in the knee on the ipsilateral side
- Corticosteroid injection in the patellar tendon on the ipsilateral side within the last 6 months
- Any confounding diagnosis to the knee joint
- Known arthritis
- Known diabetes
Show all 13Show fewer
- Known rheumatic disorders
- Inability to follow rehabilitation or complete follow-ups
- Enrolled in a resistance based-rehabilitation program for the affected patellar tendon within the previous 3 months
- Have an occupation where it is not feasible to avoid pain provoking tasks
- Pregnancy
- Have sleeping disorders or disruptions, e.g., night shift work
- Use of medicines or supplements known to affect collagen synthesis or sleep
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Institute of Sports Medicine Copenhagen
Copenhagen NV, Capital Region, 2400
Chloé Yeung, PhD, 004561461988, ching-yan.chloe.yeung@regionh.dk
Michael Kjær, PhD, michaelkjaer@sund.ku.dk
About this study
Official title: Tendinopathy: Optimal Time for Management Through Exercise (TENDOTIME) - a Randomised Controlled Study Comparing Targeted Training Performed Morning and Late Afternoon in a 12-week Intervention Program on Chronic Patellar Tendinopathy
The study is a 12-week human study where 60 participants with chronic patellar tendinopathy (more than 3 months symptoms duration) are randomised to undergo 12 weeks of targeted resistance exercise either in the morning or in the late afternoon. The overall aim is to investigate when the best time of the day to perform muscular strength training therapy towards tendinopathy is. The study will also include 10 healthy controls who will not perform any exercise training.
- Conditions
- Tendinopathy, Jumper's Knee
- Being tested
- Resistance training for knee extensors
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training for knee extensorsOther
The exercise will be started at 60% of 1 repetition maximum (RM) and progressed to 75% of 1 RM during the first 3 weeks and maintained throughout the intervention period. The exercise will be performed slowly (6 s/ repetition).
| Study group | Role | What they receive |
|---|---|---|
| Morning exercise | Experimental | Three sessions per week of targeted resistance exercise targeting the quadriceps muscles performed between 6:00 and 8:00 for 12 weeks. Receives: Other: Resistance training for knee extensors |
| Late afternoon exercise | Experimental | Three sessions per week of targeted resistance exercise targeting the quadriceps muscles performed between 16:00 and 18:00 for 12 weeks. Receives: Other: Resistance training for knee extensors |
| Healthy control | No intervention | Healthy individuals without tendinopathy as controls for the transcriptomics and proteomics analyses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient perception VISA-P
Change in Victorian Institute of Sports Assessment - patella (VISA-P) total score. The VISA-P asses symptoms, function and the ability to participate in sport. It consists of 8 questions, with a maximum score of 100 indicating the person is asymptomatic and fully per-forming and lower scores indicating more symptoms and limitations of function and activity.
Measured: Change from baseline at week 12.
Secondary outcomes (16)
Patient perception VISA-P truncated
Change in Victorian Institute of Sports Assessment - patella (VISA-P) truncated score. The truncated score only including questions 2-6, with a maximum score of 50. Lower scores indicating more symptoms and limitations of function and activity.
Measured: Change from baseline at week 12 and 52.
Patient perception VISA-P
Change in Victorian Institute of Sports Assessment - patella (VISA-P) total score. The VISA-P asses symptoms, function and the ability to participate in sport. It consists of 8 questions, with a maximum score of 100 indicating the person is asymptomatic and fully per-forming and lower scores indicating more symptoms and limitations of function and activity.
Measured: Change from baseline at week 52.
Self-reported improvement (GROC)
Self-reported improvement after treatment will be evaluated by the Global Rating of change (GROC) on a 7-point Likert scale ranging from 'much improved' to 'much worse'.
Measured: Change from baseline at week 12 and 52.
Self-reported satisfaction (PASS)
Self-evaluated satisfaction with treatment result will be evaluated by Patient Acceptable Symptom State (PASS) on a 5-point Likert scale ranging from 'very satisfied' to 'very unsatisfied'.
Measured: Change from baseline at week 12 and 52.
Counter movement jump height
Jump height during counter movement jump test will be used to assess patellar tendinopathy caused functional deficits.
Measured: Change from baseline at week 52.
Pain during single-leg decline squat (SLDS)
Participants performed a decline squat on a 25°decline board and reported pain using an 11 point numeric rating scale (NRS) upon completion, with 10 being the worst imaginable pain and 0 denoting no pain.
Measured: Change from baseline at week 12 and 52.
Ultrasonography - tendon thickness
Grey scale ultrasonography will be used for evaluation of patellar tendon thickness.
Measured: Change from baseline at week 12 and 52.
Ultrasonography - power Doppler
Doppler ultrasonography will be used for evaluation of patellar tendon vascularization/blood flow.
Measured: Change from baseline at week 12 and 52.
Lean mass by dual-energy X-ray absorptiometry
Change in quadriceps lean muscle mass by DEXA.
Measured: Change from baseline at week 12.
Expression of circadian clock genes
Changes in expression of circadian clock genes and known tendon clock target genes by tendon tissue biopsies measured in the bulk RNA by RNA sequencing and reverse transcription-quantitative polymerase chain reaction (RT-qPCR).
Measured: Change from baseline at week 12, compared to healthy controls.
Expression of extracellular matrix (ECM) and ECM regulator genes
Changes in expression of ECM and ECM regulator genes by tendon tissue biopsies measured in the bulk RNA by RNA sequencing and reverse transcription-quantitative polymerase chain reaction (RT-qPCR).
Measured: Change from baseline at week 12, compared to healthy controls.
Global expression of genes
Unbiased examination of global changes in expression of genes by tendon tissue biopsies measured in the bulk RNA by RNA sequencing.
Measured: Change from baseline at week 12, compared to healthy controls.
Histochemical staining of tendon sections
Morphology of tendon tissue regions, including cells and blood vessels, measured by histochemical and immunohistochemical stainings of tendon tissue biopsies.
Measured: Change from baseline at week 12, compared to healthy controls.
Spatial changes of gene expression
Unbiased examination of global changes in expression of genes in regions of interests of tendon tissue biopsies measured by spatial transcriptomics.
Measured: Change from baseline at week 12, compared to healthy controls.
Spatial changes of extracellular matrix protein levels
Unbiased examination of global changes in levels of extracellular matrix proteins in regions of interests of tendon tissue biopsies measured by spatial transcriptomics.
Measured: Change from baseline at week 12, compared to healthy controls.
Blood samples
Identification of potential biomarkers of tendon injury and repair by metabolomics and proteomics.
Measured: Change from baseline at week 12, compared to healthy controls.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start10 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chloé Yeung, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217432
- Sponsor's protocol ID
- TENDOTIME
- Acronym
- TENDOTIME
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tendinopathy: Optimal Time for Management Through Exercise (TENDOTIME) - a Randomised Controlled Study Comparing Targeted Training Performed Morning and Late Afternoon in a 12-week Intervention Program on Chronic Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT06217432
- Acronym / sponsor ID
- TENDOTIME / TENDOTIME
- Conditions
- Tendinopathy, Jumper's Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Jan 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.
The study is a 12-week human study where 60 participants with chronic patellar tendinopathy (more than 3 months symptoms duration) are randomised to undergo 12 weeks of targeted resistance exercise either in the morning or in the late afternoon. The overall aim is to investigate when the best time of the day to perform muscular strength training therapy towards tendinopathy is. The study will also include 10 healthy controls who will not perform any exercise training.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Morning exercise | Experimental | Other: Resistance training for knee extensorsThree sessions per week of targeted resistance exercise targeting the quadriceps muscles performed between 6:00 and 8:00 for 12 weeks. |
| Late afternoon exercise | Experimental | Other: Resistance training for knee extensorsThree sessions per week of targeted resistance exercise targeting the quadriceps muscles performed between 16:00 and 18:00 for 12 weeks. |
| Healthy control | No intervention | –Healthy individuals without tendinopathy as controls for the transcriptomics and proteomics analyses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Sports active men and women
- Age (18-55) years old
- BMI (18.5-30)
- Uni- or bilateral patellar tendinopathy
- Symptom onset >90 days ago
Key exclusion criteria (13 listed)
- Patellar tendinopathy longer than 24 months
- Previous surgery in the knee on the ipsilateral side
- Corticosteroid injection in the patellar tendon on the ipsilateral side within the last 6 months
- Any confounding diagnosis to the knee joint
- Known arthritis
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 |
|---|---|---|
| Resistance training for knee extensorsThe exercise will be started at 60% of 1 repetition maximum (RM) and progressed to 75% of 1 RM during the first 3 weeks and maintained throughout the intervention period. The exercise will be performed slowly (6 s/ repetition). | Other | Late afternoon exercise, Morning exercise |
Primary outcome
Patient perception VISA-P
Time frame: Change from baseline at week 12.
Change in Victorian Institute of Sports Assessment - patella (VISA-P) total score. The VISA-P asses symptoms, function and the ability to participate in sport. It consists of 8 questions, with a maximum score of 100 indicating the person is asymptomatic and fully per-forming and lower scores indicating more symptoms and limitations of function and activity.
16 secondary outcomes
Patient perception VISA-P truncated
Time frame: Change from baseline at week 12 and 52.
Patient perception VISA-P
Time frame: Change from baseline at week 52.
Self-reported improvement (GROC)
Time frame: Change from baseline at week 12 and 52.
Self-reported satisfaction (PASS)
Time frame: Change from baseline at week 12 and 52.
Counter movement jump height
Time frame: Change from baseline at week 52.
Pain during single-leg decline squat (SLDS)
Time frame: Change from baseline at week 12 and 52.
Ultrasonography - tendon thickness
Time frame: Change from baseline at week 12 and 52.
Ultrasonography - power Doppler
Time frame: Change from baseline at week 12 and 52.
Lean mass by dual-energy X-ray absorptiometry
Time frame: Change from baseline at week 12.
Expression of circadian clock genes
Time frame: Change from baseline at week 12, compared to healthy controls.
Expression of extracellular matrix (ECM) and ECM regulator genes
Time frame: Change from baseline at week 12, compared to healthy controls.
Global expression of genes
Time frame: Change from baseline at week 12, compared to healthy controls.
Histochemical staining of tendon sections
Time frame: Change from baseline at week 12, compared to healthy controls.
Spatial changes of gene expression
Time frame: Change from baseline at week 12, compared to healthy controls.
Spatial changes of extracellular matrix protein levels
Time frame: Change from baseline at week 12, compared to healthy controls.
Blood samples
Time frame: Change from baseline at week 12, compared to healthy controls.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training for knee extensors in people with Tendinopathy and Jumper's Knee, run by Bispebjerg Hospital at 1 site in Denmark.
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 5 inclusion and 13 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 22 Jan 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 Denmark. 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 Chloé Yeung, PhD (004561461988, ching-yan.chloe.yeung@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient perception VISA-P (time frame: Change from baseline at week 12.). 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 22 Jan 2024.