Exercise in Patients With Hypermobile Joints and Knee Pain

Not Applicable

Recruiting

• Conditions: Hypermobility Syndrome; Knee Discomfort; Hypermobility, Joint
• Interventions: Other: High-load strength training for the knee; Other: Neuromuscular training for the knee

• Registration Number: NCT06277401
• Lead Sponsor: University of Southern Denmark

Brief 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.

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.

Study Timeline

• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-17
• Study Start: 2024-02-21
• Study First Posted: 2024-02-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	High-load strength training for the knee	Progressive high-load resistance training program performed twice weekly for 12 weeks
Standard care	Neuromuscular training for the knee	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

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale Nominated Activity	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.

Secondary Outcome Measures

Name	Time	Method
Single-Leg-Hop for Distance	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.
Dynamic knee strength	Baseline, 12 weeks	Dynamic leg strength will be established by a 5-repetition maximum leg press (single leg) by a standardised protocol.
Adverse events	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.
Knee injury and Osteoarthritis Outcome Score (KOOS)	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)
Knee reposition sense	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)

Trial Locations

Locations (2)

Physiotherapy Clinics Region of Southern Denmark; 🇩🇰 Odense, Fyn, Denmark

University of Southern Denmark; 🇩🇰 Odense, Fyn, Denmark