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Not yet recruiting NCT07626957

Hamstring Strengthening in Hypermobile Conditions

No phase Interventional Hypermobile EDS (hEDS) Hypermobile Ehlers-Danlos Syndrome Hypermobile Spectrum Disorder Hypermobility Type Ehlers-Danlos Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Progressive resistance exercise with an emphasis on eccentric hamstring loading..
Who it may be relevant to
Registry conditions: Hypermobile EDS (hEDS), Hypermobile Ehlers-Danlos Syndrome, Hypermobile Spectrum Disorder, Hypermobility Type Ehlers-Danlos Syndrome. Basic parameters: 18 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects and Feasibility of Eccentric Hamstring Strengthening in Hypermobility Spectrum Disorders and Hypermobile Ehlers-Danlos Syndrome

Overview

The goal of this clinical trial is to determine how strengthening the hamstring muscles affects the knee joint in people living with hypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS). The main questions it aims to answer are: * Does hamstring strengthening reduce the looseness of the knee joint in HSD/hEDS? * Does hamstring strengthening improve clinical outcomes like pain in people living with HSD/hEDS? Participants will: * Attend two exercise classes per week for 12 weeks. * Visit the laboratory every 4-6 weeks for testing.

Detailed description

Hypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS) affect 1 in 500 people, predominantly females. While exercise is known to be beneficial for HSD/hEDS, the effect of eccentric exercise on passive joint stability, the functional capacity to perform daily activities, and quality of life remains unknown. This clinical trial aims to determine the effects of a 12-week eccentric hamstring strengthening intervention for females with HSD/hEDS on knee joint laxity, performance during walking and stair climbing, and quality of life. This study will have important implications for understanding the impacts of exercise in HSD/hEDS. This can then inform clinical guidance and recommendations around lower limb exercise for this population.

Interventions

  • Behavioral Progressive resistance exercise with an emphasis on eccentric hamstring loading.
    The exercise intervention consists of a 12-week supervised lower limb strengthening program focused on eccentric hamstring loading. This program is adapted from a lower limb progressive resistance training protocol that was well-tolerated and effective in people with HSD/hEDS. Each exercise session will start with a 10-minute aerobic warm up. This will be followed by the lower limb strengthening exercises, and a 5-minute aerobic cooldown. The lower limb exercises will include forward lunges and

Primary outcome measures

  • Knee Joint Laxity [Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
Secondary outcome measures (8)
  • Knee Joint Stiffness [Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
  • Isokinetic eccentric knee flexion strength [Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
  • Isokinetic concentric knee flexion strength [Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
  • Hamstrings:Quadriceps Co-Activation [Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
  • 6-Minute Walk Test [Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
  • Pain Severity Score [Time frame: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).]
  • Safety of the Intervention [Time frame: Monitored throughout the study from baseline to 24 weeks.]
  • Tolerability of the Intervention [Time frame: Monitored throughout the study, from baseline to week 24.]

Eligibility criteria

Inclusion criteria

  • Reported diagnosis of HSD or hEDS by a physician
  • Meet the 2017 International Diagnostic Criteria for HSD and hEDS
  • Clearance to participant in exercise participation, determined using the Get Active Questionnaire

Exclusion criteria

  • Other acquired or hereditary connective tissue disorder (i.e., rheumatoid arthritis, Marfan syndrome, etc.)
  • Currently experiencing daily knee pain
  • Prior knee injury or surgery
  • Intra-articular knee injection in the last 12 months
  • Currently pregnant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Canada · 1 center
  • University of Calgary - Foothills Campus — Calgary

Identifiers

NCT: NCT07626957 · REB26-0442

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗