Exercise in Patients With Hypermobile Joints and Knee Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Southern Denmark
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Neuromuscular training for the knee
Other interventionThe exercise programme includes exercises identified in literature to target muscles around the knee.
High-load strength training for the knee
Other interventionThe exercise programme includes exercises identified in literature to target muscles around the knee.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline, 6 weeks, 12 weeks (primary endpoint), 12 monthsSecondary outcomes
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)
Time frame
Baseline, 12 weeks, 12 months2
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.
Time frame
Up to 12 months3
Dynamic knee strength
Dynamic leg strength will be established by a 5-repetition maximum leg press (single leg) by a standardised protocol.
Time frame
Baseline, 12 weeks4
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)
Time frame
Baseline, 12 weeksOther outcomes
1
Knee pain past week
Knee pain for the past week is measured using the Visual Analogue Scale (0-100, 100 = worse)
Time frame
Baseline, 6 weeks, 12 weeks, 12 months2
Tampa scale of Kinesiophobia (TSK) 11 item
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 months3
EQ-5D-5L
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 months4
EQ VAS
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
Baseline, 12 weeks, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern Denmark
Lead sponsor
Independent Research Fund Denmark
Collaborator
Odense Patient Data Explorative Network
Collaborator
Source ClinicalTrials.gov