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

January 19, 2024 updated by: Chloé Yeung, Bispebjerg Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Morning exercise
Three sessions per week of targeted resistance exercise targeting the quadriceps muscles performed between 6:00 and 8:00 for 12 weeks.
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).
Experimental: Late afternoon exercise
Three sessions per week of targeted resistance exercise targeting the quadriceps muscles performed between 16:00 and 18:00 for 12 weeks.
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).
No Intervention: Healthy control
Healthy individuals without tendinopathy as controls for the transcriptomics and proteomics analyses.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at week 12.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ultrasonography - tendon thickness
Time Frame: Change from baseline at week 12 and 52.
Grey scale ultrasonography will be used for evaluation of patellar tendon thickness.
Change from baseline at week 12 and 52.
Patient perception VISA-P truncated
Time Frame: Change from baseline at week 12 and 52.
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.
Patient perception VISA-P
Time Frame: Change from baseline at week 52.
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.
Self-reported improvement (GROC)
Time Frame: Change from baseline at week 12 and 52.
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.
Self-reported satisfaction (PASS)
Time Frame: Change from baseline at week 12 and 52.
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.
Counter movement jump height
Time Frame: Change from baseline at week 52.
Jump height during counter movement jump test will be used to assess patellar tendinopathy caused functional deficits.
Change from baseline at week 52.
Pain during single-leg decline squat (SLDS)
Time Frame: Change from baseline at week 12 and 52.
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.
Ultrasonography - power Doppler
Time Frame: Change from baseline at week 12 and 52.
Doppler ultrasonography will be used for evaluation of patellar tendon vascularization/blood flow.
Change from baseline at week 12 and 52.
Lean mass by dual-energy X-ray absorptiometry
Time Frame: Change from baseline at week 12.
Change in quadriceps lean muscle mass by DEXA.
Change from baseline at week 12.
Expression of circadian clock genes
Time Frame: Change from baseline at week 12, compared to healthy controls.
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.
Expression of extracellular matrix (ECM) and ECM regulator genes
Time Frame: Change from baseline at week 12, compared to healthy controls.
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.
Global expression of genes
Time Frame: Change from baseline at week 12, compared to healthy controls.
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.
Histochemical staining of tendon sections
Time Frame: Change from baseline at week 12, compared to healthy controls.
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.
Spatial changes of gene expression
Time Frame: Change from baseline at week 12, compared to healthy controls.
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.
Spatial changes of extracellular matrix protein levels
Time Frame: Change from baseline at week 12, compared to healthy controls.
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.
Blood samples
Time Frame: Change from baseline at week 12, compared to healthy controls.
Identification of potential biomarkers of tendon injury and repair by metabolomics and proteomics.
Change from baseline at week 12, compared to healthy controls.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TENDOTIME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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