A Study of the Effect of Time-of-day of Training on Chronic Patellar Tendinopathy

Tendinopathy Clinical Trial

— TENDOTIME  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06217432
• Other study ID #: TENDOTIME
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Bispebjerg Hospital
• Contact: Chloé Yeung, PhD
• Phone: 004561461988
• Email: ching-yan.chloe.yeung[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Jumper's Knee
• Tendinopathy

Intervention

Other:
• Resistance training for knee extensors
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).

Locations

Country	Name	City	State
Denmark	Institute of Sports Medicine Copenhagen	Copenhagen NV	Region Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline at week 12.
Secondary	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.	Change from baseline at week 12 and 52.
Secondary	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.	Change from baseline at week 52.
Secondary	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'.	Change from baseline at week 12 and 52.
Secondary	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'.	Change from baseline at week 12 and 52.
Secondary	Counter movement jump height	Jump height during counter movement jump test will be used to assess patellar tendinopathy caused functional deficits.	Change from baseline at week 52.
Secondary	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.	Change from baseline at week 12 and 52.
Secondary	Ultrasonography - tendon thickness	Grey scale ultrasonography will be used for evaluation of patellar tendon thickness.	Change from baseline at week 12 and 52.
Secondary	Ultrasonography - power Doppler	Doppler ultrasonography will be used for evaluation of patellar tendon vascularization/blood flow.	Change from baseline at week 12 and 52.
Secondary	Lean mass by dual-energy X-ray absorptiometry	Change in quadriceps lean muscle mass by DEXA.	Change from baseline at week 12.
Secondary	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).	Change from baseline at week 12, compared to healthy controls.
Secondary	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).	Change from baseline at week 12, compared to healthy controls.
Secondary	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.	Change from baseline at week 12, compared to healthy controls.
Secondary	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.	Change from baseline at week 12, compared to healthy controls.
Secondary	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.	Change from baseline at week 12, compared to healthy controls.
Secondary	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.	Change from baseline at week 12, compared to healthy controls.
Secondary	Blood samples	Identification of potential biomarkers of tendon injury and repair by metabolomics and proteomics.	Change from baseline at week 12, compared to healthy controls.