Influence of Restitution Time in Treatment of Patellar Tendinopathy

NCT05731037 | Active Not Recruiting DMC

• 1 other identifier: The TEREX trial
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present project is to investigate if the restitution time from loading in an exercise-based 12 weeks rehabilitation regime for patellar tendinopathy influences the clinical outcome, tendon structure and function. The investigators hypothesize that greater restitution from loading (1 exercise day per week) will yield a greater positive clinical outcome, and tissue structure and function in patients with patellar tendinopathy compared to less restitution (3 exercise days per week), when impact activities are restricted in both groups.

Conditions

Patellar Tendinopathy; Jumper'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 (18)

• Patient perception VISA-P secondary

  Change from baseline at week 16 and 52

• Patient perception VISA-P truncated

  Change from baseline at week 12, 16 and 52

• Self-reported pain (NRS) - Preferred sport

  Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.

• Self-reported pain (NRS) - Rest

  Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.

• Self-reported pain (NRS) - Daily activities

  Change from baseline at week 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52.

Other Outcomes (12)

• Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique - Brain structure mapping.

  At 12 weeks

• Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique - Brain function mapping.

  At 12 weeks

• Magnetic resonance imaging (MRI) with Blood Oxygenation Level Dependent (BOLD) imaging technique - Brain metabolism mapping.

  At 12 weeks

Study Arms (2)

Short restitution group (SR)

ACTIVE COMPARATOR

Resistance training for knee extensors three training session per week.

Other: Resistance training for knee extensors

Extended restitution group (ER)

EXPERIMENTAL

Resistance training for knee extensors on training session per week (greater restitution from loading).

Other: Resistance training for knee extensors

Interventions

Resistance training for knee extensors OTHER

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).

Extended restitution group (ER); Short restitution group (SR)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sports active men and women.
• Age (18-60) years old.
• BMI (18.5-30)
• Understand and read Danish
• Uni- or bilateral patellar tendinopathy
• Symptom onset \>90 days ago

You may not qualify if:

• Patellar tendinopathy longer than 24 months
• Smoking
• 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
• Inability to follow rehabilitation or complete follow-ups
• Enrolled in a resistance based-rehabilitation program for the affected patellar tendon within the previous three month
• Have a work were it is not feasible to avoid pain provoking tasks
• Extra criteria sub-study one
• Five patients from the main study, rating "improved" and "not improved" respectively, will be invited to participate in sub-study one.
• Claustrophobia
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Department of Physical & Occupational Therapy/ Institute of Sports Medicine, Bispebjerg Hospital

Copenhagen, NV, 2400, Denmark

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 16, 2023
• Study Start: March 2, 2023
• Primary Completion: February 10, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)