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Hypermobility, JointHIPEr-KneeNCT06277401

Exercise in Patients With Hypermobile Joints and Knee Pain

A study testing Neuromuscular training for the knee and High-load strength training for the knee in people with Hypermobility, Joint and Hypermobility Syndrome, run by University of Southern Denmark at 2 sites in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
What is being tested?
Neuromuscular training for the knee and High-load strength training for the knee
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesDenmark
Study dates
21 Feb 2024to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Physiotherapy Clinics Region of Southern Denmark

    Odense, Fyn, 5000

  • University of Southern Denmark

    Odense, Fyn, 5230

Other trials in Denmark

About this study

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)

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.

Read the 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.

Being tested
Neuromuscular training for the knee, High-load strength training for the knee
Keywords
Hypermobility, Knee pain, Treatment, Randomised controlled trial
Medical subject headings
Joint Instability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular training for the kneeOther

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

  • High-load strength training for the kneeOther

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

Study groups in NCT06277401
Study groupRoleWhat they receive
InterventionExperimentalProgressive high-load resistance training program performed twice weekly for 12 weeks
Receives: Other: High-load strength training for the knee
Standard careActive comparatorThe standard care group will receive instructions on a neuromuscular training program with focus on knee stability and function performed at low intensities to be conducted twice weekly for 12 weeks
Receives: Other: Neuromuscular training for the knee

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analogue Scale Nominated Activity

    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.

    Measured: Baseline, 6 weeks, 12 weeks (primary endpoint), 12 months

Secondary outcomes (5)

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    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)

    Measured: Baseline, 12 weeks, 12 months

  2. Adverse events

    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.

    Measured: Up to 12 months

  3. Dynamic knee strength

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

    Measured: Baseline, 12 weeks

  4. Knee reposition sense

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

    Measured: Baseline, 12 weeks

  5. Single-Leg-Hop for Distance

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

    Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start21 Feb 2024
  3. Primary completionSep 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06277401
Sponsor's protocol ID
RCT_hypermobile_knee
Acronym
HIPEr-Knee
Status last verified
Sep 2026
First submitted
9 Feb 2024
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 39414294

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular training for the knee and High-load strength training for the knee in people with Hypermobility, Joint and Hypermobility Syndrome, run by University of Southern Denmark at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale Nominated Activity (time frame: Baseline, 6 weeks, 12 weeks (primary endpoint), 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06277401, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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