NCT06217432

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

January 10, 2024

Last Update Submit

January 19, 2024

Conditions

TendinopathyJumper's Knee

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Patient perception VISA-P truncated

    Change from baseline at week 12 and 52.

  • Patient perception VISA-P

    Change from baseline at week 52.

  • Self-reported improvement (GROC)

    Change from baseline at week 12 and 52.

  • Self-reported satisfaction (PASS)

    Change from baseline at week 12 and 52.

  • Counter movement jump height

    Change from baseline at week 52.

  • +11 more secondary outcomes

Study Arms (3)

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.

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.

Other: Resistance training for knee extensors

Healthy control

NO INTERVENTION

Healthy individuals without tendinopathy as controls for the transcriptomics and proteomics analyses.

Interventions

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).

Late afternoon exerciseMorning exercise

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine Copenhagen

Copenhagen NV, Capital Region, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Tendinopathy

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Chloé Yeung, PhD

CONTACT

004561461988ching-yan.chloe.yeung@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 22, 2024

Study Start

January 10, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

January 22, 2024

Record last verified: 2024-01

Locations

DK(1)