Hamstring Strengthening in Hypermobile Conditions

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorUniversity of Calgary

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Progressive resistance exercise with an emphasis on eccentric hamstring loading.

    Behavioral

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Eccentric hamstring exerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Knee Joint Laxity

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.

Time frame
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).

Secondary outcomes

1

Knee Joint Stiffness

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.

Time frame
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
2

Isokinetic eccentric knee flexion strength

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.

Time frame
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
3

Isokinetic concentric knee flexion strength

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.

Time frame
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
4

Hamstrings:Quadriceps Co-Activation

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.

Time frame
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).

Other outcomes

1

Acceptability of the Intervention

Participants will be asked open ended questions via an online survey at 12, 18 and 24 weeks after baseline asking about how acceptable they found the exercise program to be.

Time frame
Measured at the follow up visits for week 12, 18, and 24.
2

Adherence and Maintenance of Exercises

Adherence to the exercise program and maintenance of the exercises following completion of the 12 weeks of supervised classes will be assessed using open ended questions via an online survey send to participants at 12, 18, and 24 weeks after baseline.

Time frame
Measured at follow up visits for week 12, 18, and 24.
3

Knee Joint Range of Motion

Knee joint range of motion will be measured in degrees both actively and passively using a goniometer. Changes in range of motion will be assessed from baseline, 4, 8 , 12, 18, and 24 weeks.

Time frame
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
4

Isometric knee flexion and extension strength

Isometric knee flexion and extension strength will be measured using dynamometry at 90 degrees of knee flexion. Changes in isometric flexion and extension strength will be assessed from baseline to 4, 8, 12, 18, and 24 weeks after baseline.

Time frame
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).

Sponsors and contacts

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