Exercise in Patients With Hypermobile Joints and Knee Pain

NCT06277401 | Recruiting

• 1 other identifier: RCT_hypermobile_knee
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypermobility, Joint; Hypermobility Syndrome; Knee Discomfort

Keywords

Hypermobility; Knee pain; Treatment; Randomised controlled trial

Outcome Measures

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.

  Baseline, 6 weeks, 12 weeks (primary endpoint), 12 months

Secondary Outcomes (5)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  Baseline, 12 weeks, 12 months

• Adverse events

  Up to 12 months

• Dynamic knee strength

  Baseline, 12 weeks

• Knee reposition sense

  Baseline, 12 weeks

• Single-Leg-Hop for Distance

  Baseline, 12 weeks

Other Outcomes (13)

• Knee pain past week

  Baseline, 6 weeks, 12 weeks, 12 months

• Tampa scale of Kinesiophobia (TSK) 11 item

  Baseline, 12 weeks, 12 months

• EQ-5D-5L

  Baseline, 12 weeks, 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: High-load strength training for the knee

Standard care

ACTIVE COMPARATOR

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

Other: Neuromuscular training for the knee

Interventions

Neuromuscular training for the knee OTHER

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

Standard care

High-load strength training for the knee OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Independent Research Fund Denmark: collaborator
• Odense Patient Data Explorative Network: collaborator

Study Sites (2)

Physiotherapy Clinics Region of Southern Denmark

Odense, Fyn, 5000, Denmark

RECRUITING

University of Southern Denmark

Odense, Fyn, 5230, Denmark

RECRUITING

Related Publications (1)

• Liaghat B, Bojsen-Moller J, Juul-Kristensen B, Henriksen P, Mohammadnejad A, Heiberg BD, Thorlund JB. High-load strength training compared with standard care treatment in young adults with joint hypermobility and knee pain: study protocol for a randomised controlled trial (the HIPEr-Knee study). BMJ Open. 2024 Oct 16;14(10):e090812. doi: 10.1136/bmjopen-2024-090812.

  PMID: 39414294 DERIVED

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Behnam Liaghat, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Jonas B Thorlund, PhD

  University of Southern Denmark

  STUDY DIRECTOR

Central Study Contacts

Behnam Liaghat, PhD

CONTACT

+4526826801; bliaghat@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 26, 2024
• Study Start: February 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)