Clinical trial NCT06217432: A Study of the Effect of Time-of-day of Training on Chronic Patellar Tendinopathy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tendinopathy
Jumper's Knee
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Sports active men and women
* Age (18-55) years old
* BMI (18.5-30)
* Uni- or bilateral patellar tendinopathy
* Symptom onset \>90 days ago

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Patient perception VISA-P
timeFrame: Change from baseline at week 12.
Secondary outcomes:
measure: Patient perception VISA-P truncated
timeFrame: Change from baseline at week 12 and 52.
measure: Patient perception VISA-P
timeFrame: Change from baseline at week 52.
measure: Self-reported improvement (GROC)
timeFrame: Change from baseline at week 12 and 52.
measure: Self-reported satisfaction (PASS)
timeFrame: Change from baseline at week 12 and 52.
measure: Counter movement jump height
timeFrame: Change from baseline at week 52.
measure: Pain during single-leg decline squat (SLDS)
timeFrame: Change from baseline at week 12 and 52.
measure: Ultrasonography - tendon thickness
timeFrame: Change from baseline at week 12 and 52.
measure: Ultrasonography - power Doppler
timeFrame: Change from baseline at week 12 and 52.
measure: Lean mass by dual-energy X-ray absorptiometry
timeFrame: Change from baseline at week 12.
measure: Expression of circadian clock genes
timeFrame: Change from baseline at week 12, compared to healthy controls.
measure: Expression of extracellular matrix (ECM) and ECM regulator genes
timeFrame: Change from baseline at week 12, compared to healthy controls.
measure: Global expression of genes
timeFrame: Change from baseline at week 12, compared to healthy controls.
measure: Histochemical staining of tendon sections
timeFrame: Change from baseline at week 12, compared to healthy controls.
measure: Spatial changes of gene expression
timeFrame: Change from baseline at week 12, compared to healthy controls.
measure: Spatial changes of extracellular matrix protein levels
timeFrame: Change from baseline at week 12, compared to healthy controls.
measure: Blood samples
timeFrame: Change from baseline at week 12, compared to healthy controls.
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Institute of Sports Medicine Copenhagen
state: Region Hovedstaden
Study officials:
References: