Hamstring Strengthening in Hypermobile Conditions

NCT07626957 | Not Yet Recruiting DMC

• 1 other identifier: REB26-0442
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypermobile EDS (hEDS); Hypermobile Ehlers-Danlos Syndrome; Hypermobile Spectrum Disorder; Hypermobility Type Ehlers-Danlos Syndrome

Keywords

Exercise; Female; Knee; Joint Laxity; Hypermobility; Joint Stiffness; Ehlers-Danlos Syndrome; Hypermobile Ehlers-Danlos Syndrome; Hypermobility Spectrum Disorders; strengthening; eccentric

Outcome Measures

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.

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

Secondary Outcomes (8)

• Knee Joint Stiffness

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

• Isokinetic eccentric knee flexion strength

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

• Isokinetic concentric knee flexion strength

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

• Hamstrings:Quadriceps Co-Activation

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

• 6-Minute Walk Test

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

Other Outcomes (15)

• Acceptability of the Intervention

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

• Adherence and Maintenance of Exercises

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

• Knee Joint Range of Motion

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

Study Arms (1)

Eccentric hamstring exercise

EXPERIMENTAL

All participants will complete a 12-week supervised lower limb strengthening program focused on eccentric hamstring loading. Participants will complete two training sessions per week with at least 48 hours between training sessions. Multiple classes will be offered each week to increase participation opportunity, with morning classes (8-9am) and evening classes (6-7pm) being offered on Mondays and Thursdays. Each class will be led by the same trained kinesiologist and cover the same training protocol within a given week, regardless of the day or time.

Behavioral: Progressive resistance exercise with an emphasis on eccentric hamstring loading.

Interventions

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.

Also known as: Exercise, Progressive Resistance Training, Eccentric Exercise

Eccentric hamstring exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary - Foothills Campus

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3; Motor Activity; Joint Instability; Ehlers-Danlos Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Joint Diseases; Musculoskeletal Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ranita Manocha

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ranita Manocha

CONTACT

4039444224; bettermobilitylab@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

CA (1)