Hypermobile EDS (hEDS), Hypermobile Ehlers-Danlos Syndrome, Hypermobile Spectrum Disorder, Hypermobility Type Ehlers-Danlos Syndrome
Conditions
Keywords
Exercise, Female, Knee, Joint Laxity, Hypermobility, Joint Stiffness, Ehlers-Danlos Syndrome, Hypermobile Ehlers-Danlos Syndrome, Hypermobility Spectrum Disorders, strengthening, eccentric
Brief summary
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
BEHAVIORALProgressive 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 seated machine weights (leg press, leg extension, leg curl, calf raise). At weeks 6-11, eccentric hamstring loading will be initiated by utilizing the 2:1 technique of two limbs performing concentric action at once and then a single limb performing the eccentric action in a seated leg curl machine. This is an established eccentric loading protocol for the hamstring muscle group.
Sponsors
University of Calgary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Joint Laxity | Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks). | Anterior knee joint laxity measured in millimeters using a KT-2000 Knee Ligament Arthrometer at 67N, 89N, and 133N of applied force, as well as maximum displacement. Posterior knee joint laxity will be assessed at 67N of applied force. Changes in knee joint laxity at each level of applied force will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Joint Stiffness | Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks). | Anterior knee joint stiffness calculated from the change in displacement divided by the change in force from 0N to 67N, 67N to 89N, and 89N to 133N. Posterior knee joint stiffness will be calculated between 0N and 67N of force. Changes in stiffness will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline. |
| Isokinetic eccentric knee flexion strength | Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks). | Isokinetic eccentric knee flexion strength at 60 degrees per second will be measured using a Biodex Dynamometer. Change in eccentric knee flexion strength will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline. |
| Isokinetic concentric knee flexion strength | Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks). | Isokinetic concentric knee flexion strength at 60 degrees per second will be measured using a Biodex dynamometer. Change in concentric knee flexion strength will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline. |
| Hamstrings:Quadriceps Co-Activation | Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks). | Co-activation between the hamstrings and quadriceps muscles will be measured using Delsys surface electromyography sensors during dynamometry, the 6-Minute Walk Test, and the stair climb test. Changes in hamstring:quadriceps co-activation will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline. |
| 6-Minute Walk Test | Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks). | Functional capacity/performance will be assessed using the 6-Minute Walk Test, which measures the distance in meters that a participant can walk in 6 minutes. Changes in performance will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline. |
| Pain Severity Score | Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks). | Pain severity score (from 0 to 40) will be calculated from the pain severity components of the Brief Pain Inventory. The Brief Pain Inventory is a questionnaire that measures the location of pain (body diagram), pain severity (4 questions with numeric rating scales from 0-10, 0 indicating "no pain" and 10 indicating "pain as bad as you can imagine"), medications or treatments, a numeric rating scale (0-100%, 0% indicating "no relief" and 100% indicating "complete relief") for relief of pain from medications or treatments, as well as pain interference (7 questions with numeric rating scales from 0-10, 0 indicating "does not interfere" and 10 indicating "completely interferes"). Changes in pain severity score will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline. |
| Safety of the Intervention | Monitored throughout the study from baseline to 24 weeks. | Safety of the intervention will be monitored and determined by the number of adverse events reported by participants to either the exercise kinesiologist during the exercise sessions, or to the research team during data collection or via email. |
| Tolerability of the Intervention | Monitored throughout the study, from baseline to week 24. | Tolerability of the exercise intervention will be assessed using the following metrics: Number of participants that withdraw from the study (along with reasons for withdrawal), number of exercises classes completed after 12 weeks, and pain severity (100mm visual analog scale) before and after each exercise class. |
Countries
Canada
Contacts
CONTACTRanita Manocha
PRINCIPAL_INVESTIGATORRanita Manocha
University of Calgary
Outcome results
None listed