Exercise in Patients With Hypermobile Joints and Knee Pain

Knee Discomfort Clinical Trial

— HIPEr-Knee  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06277401
• Other study ID #: RCT_hypermobile_knee
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: University of Southern Denmark
• Contact: Behnam Liaghat, PhD
• Phone: +4526826801
• Email: bliaghat[@]health.sdu.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypermobility Syndrome
• Hypermobility, Joint
• Joint Instability
• Knee Discomfort

Intervention

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

Locations

Country	Name	City	State
Denmark	Physiotherapy Clinics Region of Southern Denmark	Odense	Fyn
Denmark	University of Southern Denmark	Odense	Fyn

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Independent Research Fund Denmark, Odense Patient Data Explorative Network

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knee pain past week	Knee pain for the past week is measured using the Visual Analogue Scale (0-100, 100 = worse)	Baseline, 6 weeks, 12 weeks, 12 months
Other	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.	Baseline, 12 weeks, 12 months
Other	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.	Baseline, 12 weeks, 12 months
Other	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).	Baseline, 12 weeks, 12 months
Other	Global perceived effect (GPE)	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)	12 weeks, 12 months
Other	PASS	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".	12 weeks, 12 months
Other	TF	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".	12 weeks, 12 months
Other	Clinical important difference	American College of Rheumatology response criteria 20% and 50%	12 weeks, 12 months
Other	Knee instability questions	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?	Baseline, 12 weeks, 12 months
Other	Tendon stiffness	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)	Baseline, 12 weeks
Other	Quadriceps rate of torque development (RTD)	Rate of torque development in the quadriceps muscle. Subgroup of patients (n = 30)	Baseline, 12 weeks
Other	Patella instability	Moving patellar apprehension test will be used to assess patella instability. Subgroup of patients (n = 30)	Baseline, 12 weeks
Other	Quadriceps maximal voluntary isometric contraction	Isometric maximal voluntary contraction in the quadriceps muscle. Subgroup of patients (n = 30)	Baseline, 12 weeks
Primary	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.	Baseline, 6 weeks, 12 weeks (primary endpoint), 12 months
Secondary	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)	Baseline, 12 weeks, 12 months
Secondary	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.	Up to 12 months
Secondary	Dynamic knee strength	Dynamic leg strength will be established by a 5-repetition maximum leg press (single leg) by a standardised protocol.	Baseline, 12 weeks
Secondary	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)	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks