Neuromuscular training for the knee
OtherThe exercise programme includes exercises identified in literature to target muscles around the knee.
NCT Number: NCT06277401
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Physiotherapy Clinics Region of Southern Denmark, Odense, Fyn, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The exercise programme includes exercises identified in literature to target muscles around the knee.
The exercise programme includes exercises identified in literature to target muscles around the knee.
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.
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)
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.
Time frame: Baseline, 12 weeks
Dynamic leg strength will be established by a 5-repetition maximum leg press (single leg) by a standardised protocol.
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)
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.
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)
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.
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.
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).
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)
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".
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".
Time frame: 12 weeks, 12 months
American College of Rheumatology response criteria 20% and 50%
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?
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)
Time frame: Baseline, 12 weeks
Rate of torque development in the quadriceps muscle. Subgroup of patients (n = 30)
Time frame: Baseline, 12 weeks
Moving patellar apprehension test will be used to assess patella instability. Subgroup of patients (n = 30)
Time frame: Baseline, 12 weeks
Isometric maximal voluntary contraction in the quadriceps muscle. Subgroup of patients (n = 30)
Contact information is provided by the study sponsor or research team.
University of Southern Denmark
Other
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
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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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