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Recruiting NCT06277401

Exercise in Patients With Hypermobile Joints and Knee Pain

No phase Interventional Hypermobility, Joint Hypermobility Syndrome Knee Discomfort

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuromuscular training for the knee, High-load strength training for the knee.
Who it may be relevant to
Registry conditions: Hypermobility, Joint, Hypermobility Syndrome, Knee Discomfort. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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)

Overview

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.

Interventions

  • Other Neuromuscular training for the knee
    The exercise programme includes exercises identified in literature to target muscles around the knee.
  • Other High-load strength training for the knee
    The exercise programme includes exercises identified in literature to target muscles around the knee.

Primary outcome measures

  • Visual Analogue Scale Nominated Activity [Time frame: Baseline, 6 weeks, 12 weeks (primary endpoint), 12 months]
Secondary outcome measures (5)
  • Knee injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Baseline, 12 weeks, 12 months]
  • Adverse events [Time frame: Up to 12 months]
  • Dynamic knee strength [Time frame: Baseline, 12 weeks]
  • Knee reposition sense [Time frame: Baseline, 12 weeks]
  • Single-Leg-Hop for Distance [Time frame: Baseline, 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Denmark · 2 centers
  • Physiotherapy Clinics Region of Southern Denmark — Odense
  • University of Southern Denmark — Odense

Publications

  • Liaghat B, Bojsen-Moller J, Juul-Kristensen B, Henriksen P, Mohammadnejad A, Heiberg BD, Thorlund JB. High-load strength training compared with standard care treatment in young adults with joint hypermobility and knee pain: study protocol for a randomised controlled trial (the HIPEr-Knee study). BMJ Open. 2024 Oct 16;14(10):e090812. doi: 10.1136/bmjopen-2024-090812. PMID 39414294

Identifiers

NCT: NCT06277401 · RCT_hypermobile_knee

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗