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NCT Number: NCT06277401

Exercise in Patients With Hypermobile Joints and Knee Pain

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy Clinics Region of Southern Denmark, Odense, Fyn, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular training for the knee

Other

The exercise programme includes exercises identified in literature to target muscles around the knee.

High-load strength training for the knee

Other

The exercise programme includes exercises identified in literature to target muscles around the knee.

Primary outcomes

  1. Visual Analogue Scale Nominated Activity

    Time frame: Baseline, 6 weeks, 12 weeks (primary endpoint), 12 months

    The primary outcome is the Self-reported knee pain during an activity nominated by patients to be the most aggravating for their present knee pain (VAS nominated activity - VASNA, 0-100, 100 = worse).

    The primary endpoint is at 12-week follow-up.

Secondary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Baseline, 12 weeks, 12 months

    Knee injury and Osteoarthritis Outcome Score is a validated knee-specific questionnaire used to assess patient-reported outcomes in the continuum from knee injury to osteoarthritis and is widely used for different types of knee pathology. (0-100, 100 = best)

  2. Adverse events

    Time frame: Up to 12 months

    Adverse events will be defined as any unintended, negative findings, symptom, or illnesses that occur during the study assessments or interventions, whether attributable to the project or not.

  3. Dynamic knee strength

    Time frame: Baseline, 12 weeks

    Dynamic leg strength will be established by a 5-repetition maximum leg press (single leg) by a standardised protocol.

  4. Knee reposition sense

    Time frame: Baseline, 12 weeks

    Sitting active knee joint reposition (proprioception) test will be performed using a HALO Digital Goniometer, to assess mean absolute angle error (AAE)

  5. Single-Leg-Hop for Distance

    Time frame: Baseline, 12 weeks

    The patients will be instructed to hop forward as far as possible and land steadily and stand still for at least three seconds.

Other outcomes

  1. Knee pain past week

    Time frame: Baseline, 6 weeks, 12 weeks, 12 months

    Knee pain for the past week is measured using the Visual Analogue Scale (0-100, 100 = worse)

  2. Tampa scale of Kinesiophobia (TSK) 11 item

    Time frame: Baseline, 12 weeks, 12 months

    Tampa scale of Kinesiophobia is used to measure impression of change in fear of movement from baseline to 16 weeks follow-up. It consists of an 11-item scale where each question is scored on a 4 point Likert scale, with 1 indicating, "strongly disagree" and 4 indicating, "strongly agree". The total scores range from 11-44, with higher scores representing increased fear of movement.

  3. EQ-5D-5L

    Time frame: Baseline, 12 weeks, 12 months

    the European Quality of life-5 Dimensions-5-Level measures change in health related quality of life and includes the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

    The EQ-5D descriptive system comprises five dimensions (mobility, Self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension is rated using a five-level ordinal scale from no problems to extreme problems. It results in a preference based index that range from states worse than death (<0), to 1 (full health), anchoring dead at 0. A score of one indicates that the participants perceived their health at the best possible state and a score below null that the participants perceived their health worse than death.

  4. EQ VAS

    Time frame: Baseline, 12 weeks, 12 months

    the European Quality of life-5 Dimensions-5-Level measures change in health related quality of life and includes the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

    The EQ VAS measures change in health related quality of life. It includes a visual analogue scale where own health 'today´ is rated on a scale from 0 (worst imaginable health) to 100 (best imaginable health).

  5. Global perceived effect (GPE)

    Time frame: 12 weeks, 12 months

    To measure the patients self-rated impression of improvement at follow-up the GPE will be used related to knee problems. GPE measures self-rated impression of improvement since baseline assessment on a 7-point scale (1 "worse, an important worsening" to 7 "better, an important improvement)

  6. PASS

    Time frame: 12 weeks, 12 months

    Patient Acceptable Symptom State "When you think of your shoulder function, will you consider your current condition as satisfying? By shoulder function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life". Answered by "yes" or "no".

  7. TF

    Time frame: 12 weeks, 12 months

    Treatment Failure Only answered by patients answering "no" to PASS. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?". Answered by "yes" or "no".

  8. Clinical important difference

    Time frame: 12 weeks, 12 months

    American College of Rheumatology response criteria 20% and 50%

  9. Knee instability questions

    Time frame: Baseline, 12 weeks, 12 months

    Within the last month, have you experienced that your knee was unstable or about to give out? To what extent has the experience of your knee feeling unstable or giving out affected your daily activity level within the last month?

  10. Tendon stiffness

    Time frame: Baseline, 12 weeks

    Stiffness of the patellar tendon is assessed based on corresponding values of tendon force and tendon deformation (measured by use of B-mode ultrasonography). Subgroup of patients (n = 30)

  11. Quadriceps rate of torque development (RTD)

    Time frame: Baseline, 12 weeks

    Rate of torque development in the quadriceps muscle. Subgroup of patients (n = 30)

  12. Patella instability

    Time frame: Baseline, 12 weeks

    Moving patellar apprehension test will be used to assess patella instability. Subgroup of patients (n = 30)

  13. Quadriceps maximal voluntary isometric contraction

    Time frame: Baseline, 12 weeks

    Isometric maximal voluntary contraction in the quadriceps muscle. Subgroup of patients (n = 30)

Study contacts

Contact information is provided by the study sponsor or research team.

Behnam Liaghat, PhD

CONTACT

[email protected]

+4526826801

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Independent Research Fund Denmark
  • Odense Patient Data Explorative Network

Registry information

Official study 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)

Acronym: HIPEr-Knee

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 26, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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