Exercise in Patients With Hypermobile Joints and Knee Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-21

Study Completion Date

2026-06-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hypermobility, Joint Hypermobility Syndrome Knee Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The patients will be kept blind to treatment allocation by being provided with minimal information about the content of the two exercise interventions and the study hypotheses; the patients will be informed that the study compares two different exercise protocols that both include safe exercises to reduce knee pain and increase knee function.

An independent biostatistician blinded to group allocation will perform the primary RCT analysis. To reduce the risk of interpretation bias, blinded results from the analyses (group A compared with group B) will be presented to all authors, who will agree on two alternative written interpretations before the data manager unblinds the randomisation code.

Study Groups

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Intervention

Progressive high-load resistance training program performed twice weekly for 12 weeks

Group Type EXPERIMENTAL

High-load strength training for the knee

Intervention Type OTHER

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

Standard care

The 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

Group Type ACTIVE_COMPARATOR

Neuromuscular training for the knee

Intervention Type OTHER

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

Interventions

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Neuromuscular training for the knee

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

Intervention Type OTHER

High-load strength training for the knee

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No