NCT03528746

Brief Summary

The purpose of this study is to compare the acute effects of two different types of resistance exercise (isometric versus isotonic) on exercise induced hypoalgesia during an aggravating activity, in participants with patellar tendinopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 12, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

December 5, 2017

Last Update Submit

October 10, 2018

Conditions

Keywords

Patellar tendinopathy

Outcome Measures

Primary Outcomes (1)

  • Change in pain during aggravating activity

    The single leg decline squat (SLDS) will be used as the provocative activity, as this is an activity that usually induces pain in patients with patellar tendinopathy. Participants will be asked to stand on one limb, with their heel raised, so they are in approximately 25 degrees of plantar flexion. They will then be asked to perform a small squat, to about 60 degrees of knee flexion. This will be repeated three times. Participants will provide a numerical pain rating score for the decline squat on an 11-point numerical rating scale (NRS), anchored at left with '0, no pain' and at right with '10, worst possible pain'. If participants have bilateral patellar tendinopathy, data from the 'most painful' limb (indicated by participants) will be used for the primary outcome.

    baseline; immedietely after exercise

Secondary Outcomes (3)

  • change in pain during aggravating activity

    baseline; 45 minutes post exercise

  • change in pressure pain threshold (kPa)

    Baseline; Immediately after exercise; 45 min post exercise

  • Change in patellar tendon thickness (mm)

    Baseline; Immedietly after exercise

Other Outcomes (1)

  • Pain (during exercise)

    Immediately after exercise set

Study Arms (2)

Isometric exercise

EXPERIMENTAL

Participants will complete isometric quadriceps exercise

Other: Isometric exercise

Isotonic exercise

ACTIVE COMPARATOR

Participants will complete dynamic leg extension

Other: Isotonic Exercise

Interventions

Participants will complete dynamic leg extension in a leg extension machine with a range of motion from approximately 90 degrees flexion to full extension. Each repetition will be completed with a 3s concentric contraction, 0s isometric and 4s eccentric contraction.This will be repeated for 8 repetitions and for 5 sets with 2 minutes rest between each set, as per Rio and colleagues. The load used during the isotonic exercise will be equivalent to participants 8 repetition maximum, which will be determined by an experienced tester in a standardised manner according to NSCA guidelines.

Also known as: resistance exercise
Isotonic exercise

Participants will complete isometric quadriceps exercise, where they must hold a load statically for 45s with their knee in 60° flexion. This will be repeated for 5 sets with 2 minutes rest between each set. A load of 70% of the maximal voluntary isometric contraction (MVIC) will be used. MVIC will be assessed in an isokinetic dynamometer as per Rio and colleagues. Participants will be seated in a stable position in the dynamometer with the knee at 60° of knee flexion. First they will be familiarised with the procedure. Standardised instructions will be issued for participants to perform a maximal effort knee extension against the dynamometer for 3seconds. After a short break, the test will be repeated three times and the MVIC will be peak torque recorded during these three efforts.

Isometric exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 18-40 years, with patellar tendinopathy will be included. Diagnosis of patellar tendinopathy, will be made by a physiotherapist (who has been trained by an experienced rheumatologist) as follows, similar to previously outlined criteria:
  • pain localised to the inferior pole of the patella during jumping and landing activities
  • pain during testing on the single-leg decline squat (SLDS)
  • The diagnosis will be confirmed by the presence of characteristic features on ultrasound imaging (eg, hypoechoic area and focal enlarged tendon).
  • Minimum pain of 3cm on a 10cm visual analogue scale (VAS)
  • Other concurrent diagnosable knee pathologies

You may not qualify if:

  • Previous surgery of the knee
  • Pregnancy
  • Corticosteroid injection within the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit for General Practice in Aalborg

Aalborg, 9000, Denmark

Location

Related Publications (1)

  • Rio E, Kidgell D, Purdam C, Gaida J, Moseley GL, Pearce AJ, Cook J. Isometric exercise induces analgesia and reduces inhibition in patellar tendinopathy. Br J Sports Med. 2015 Oct;49(19):1277-83. doi: 10.1136/bjsports-2014-094386. Epub 2015 May 15.

    PMID: 25979840BACKGROUND

MeSH Terms

Interventions

Resistance TrainingExercise

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to the study hypothesis
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The proposed study is a participant blinded, randomised crossover superiority trial, to examine acute effect of isometric versus isotonic resistance exercise on pain in patients with patellar tendinopathy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post- Doctoral Research Fellow

Study Record Dates

First Submitted

December 5, 2017

First Posted

May 18, 2018

Study Start

July 12, 2018

Primary Completion

October 3, 2018

Study Completion

October 3, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations