Clinical trial NCT06277401: Exercise in Patients With Hypermobile Joints and Knee Pain
Official title: High-load Resistance Training Compared With Usual Care for Treatment of Painful Knee Joint Hypermobility in Young Adults: A Randomised Controlled Trial (the HIPEr-Knee Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypermobility, Joint
Hypermobility Syndrome
Knee Discomfort
Keywords: Hypermobility
Knee pain
Treatment
Randomised controlled trial
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Independent Research Fund Denmark
name: Odense Patient Data Explorative Network
First posted: 2024-02-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain associated with knee joint hypermobility is common in the adult population, but evidence on treatment is sparse. This study investigates if high-load resistance training is superior to usual care in improving activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain.

Detailed description: Knee joint hypermobility is common in the adult population. Patients with knee joint hypermobility and knee pain are typically managed with low intensity resistance training and proprioceptive training to reduce knee pain and improve function, but many patients do not respond well to these treatment strategies. High-load resistance training offers additional benefits to low intensity resistance training, including marked increase in muscle cross-sectional area, neural drive, and increased tendon stiffness, all important components of acquiring active knee joint stability during movement tasks and daily life. Therefore, the primary aim of this randomised controlled trial (RCT) is to investigate if high-load resistance training is superior to usual care in reducing activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain.

Eligibility criteria: Inclusion criteria

* Persistent knee pain for ≥ 3 months (self-reported)
* Knee pain ≥ 30mm during the last week using a 0-100 mm visual analogue scale (VAS; 0=no pain and 100=worst imaginable pain) (self-reported)
* Generalised joint hypermobility assessed with the Five-Part Hypermobility Questionnaire (positive ≥ 2/5) (self-reported)
* Local knee joint hypermobility using the passive hyperextension of the knee in standing (positive \> 10 degrees of hyperextension) and confirmed in supine lying (heel resting on 20 cm high block on the bench surface), with passive knee hyperextension (positive \> 10 degrees) (objectively measured)

Exclusion criteria

* Diagnosed with patellar tendinopathy
* Pregnancy or childbirth within the past year (due to increased levels of relaxin that could affect joint stability)
* Knee surgery within the past year
* Participation in regular structured resistance training within the past six months
* Inability to speak and understand Danish.
* All types of Ehlers-Danlos syndrome
* Other heritable connective tissue disorders such as Marfan syndrome, osteogenesis imperfecta, Loeys-Dietz syndrome, Stickler syndrome, skeletal dysplasias
* Autoimmune rheumatic connective tissue disorders such as lupus, rheumatoid arthritis; Chromosomal conditions such as Fragile X syndrome, Kabuki syndrome, Down syndrome
* Neuromuscular disorders that can cause joints to become unstable, such as multiple sclerosis

Primary outcomes:
measure: Visual Analogue Scale Nominated Activity
timeFrame: Baseline, 6 weeks, 12 weeks (primary endpoint), 12 months
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, 12 weeks, 12 months
measure: Adverse events
timeFrame: Up to 12 months
measure: Dynamic knee strength
timeFrame: Baseline, 12 weeks
measure: Knee reposition sense
timeFrame: Baseline, 12 weeks
measure: Single-Leg-Hop for Distance
timeFrame: Baseline, 12 weeks
Other outcomes:
measure: Knee pain past week
timeFrame: Baseline, 6 weeks, 12 weeks, 12 months
measure: Tampa scale of Kinesiophobia (TSK) 11 item
timeFrame: Baseline, 12 weeks, 12 months
measure: EQ-5D-5L
timeFrame: Baseline, 12 weeks, 12 months
measure: EQ VAS
timeFrame: Baseline, 12 weeks, 12 months
measure: Global perceived effect (GPE)
timeFrame: 12 weeks, 12 months
measure: PASS
timeFrame: 12 weeks, 12 months
measure: TF
timeFrame: 12 weeks, 12 months
measure: Clinical important difference
timeFrame: 12 weeks, 12 months
measure: Knee instability questions
timeFrame: Baseline, 12 weeks, 12 months
measure: Tendon stiffness
timeFrame: Baseline, 12 weeks
measure: Quadriceps rate of torque development (RTD)
timeFrame: Baseline, 12 weeks
measure: Patella instability
timeFrame: Baseline, 12 weeks
measure: Quadriceps maximal voluntary isometric contraction
timeFrame: Baseline, 12 weeks
Locations:
city: Odense
country: Denmark
facility: Physiotherapy Clinics Region of Southern Denmark
state: Fyn
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Fyn
Study officials:
affiliation: University of Southern Denmark
name: Behnam Liaghat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Jonas B Thorlund, PhD
role: STUDY_DIRECTOR
References: