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Hamstring Strengthening in Hypermobile Conditions

29 maja 2026 zaktualizowane przez: Ranita Manocha, University of Calgary

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

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 4N1
        • University of Calgary - Foothills Campus
        • Kontakt:
        • Główny śledczy:
          • Ranita Manocha, MD, MSc

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Eccentric hamstring exercise
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.
Behawioralne: 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 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.
Inne nazwy:
  • Ćwiczenie
  • Progressive Resistance Training
  • Eccentric Exercise

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Knee Joint Laxity
Ramy czasowe: 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.
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Knee Joint Stiffness
Ramy czasowe: 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.
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Isokinetic eccentric knee flexion strength
Ramy czasowe: 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.
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Isokinetic concentric knee flexion strength
Ramy czasowe: 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.
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Hamstrings:Quadriceps Co-Activation
Ramy czasowe: 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.
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
6-Minute Walk Test
Ramy czasowe: 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.
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Pain Severity Score
Ramy czasowe: 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.
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Safety of the Intervention
Ramy czasowe: 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.
Monitored throughout the study from baseline to 24 weeks.
Tolerability of the Intervention
Ramy czasowe: 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.
Monitored throughout the study, from baseline to week 24.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Acceptability of the Intervention
Ramy czasowe: Measured at the follow up visits for week 12, 18, and 24.
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.
Measured at the follow up visits for week 12, 18, and 24.
Adherence and Maintenance of Exercises
Ramy czasowe: Measured at follow up visits for week 12, 18, and 24.
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.
Measured at follow up visits for week 12, 18, and 24.
Knee Joint Range of Motion
Ramy czasowe: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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.
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Isometric knee flexion and extension strength
Ramy czasowe: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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.
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Stair Climb Test
Ramy czasowe: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Functional capacity/performance will also be assessed using a Stair Climb Test, which measures the time that a participant can ascend and descent a set of stairs. Changes in performance 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).
Pain Interference Score
Ramy czasowe: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Pain interference score (from 0 to 70) 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 interference score 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).
Knee Pain
Ramy czasowe: Measured before and after each exercise class, and at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Knee pain will be determined before and after each exercise session using a 100mm visual analog scale (VAS), with 0 indicating "no pain" and 100 indicating "pain as bad as you can imagine". Knee pain will also be determined at baseline and each follow up assessment using a 100mm VAS for the average knee pain over the last 7 days during rest and during walking, with 0 indicating "no pain" and 100 indicating "pain as bad as you can imagine".
Measured before and after each exercise class, and at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Kinesiophobia
Ramy czasowe: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Fear related to physical activity will be measured using the Tampa Scale for Kinesiophobia at baseline and each follow up assessment. The Tampa Scale is scored from 17 questions related to pain, injury, physical activity, and fear. The answers for each question are structured as a 4 point Likert scale (1 - "strongly disagree", 2 - "disagree", 3 - "agree", or 4 - "strongly agree").
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Fatigue
Ramy czasowe: Measured before and after each exercise class, and at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Generalized fatigue will be measured using the Fatigue Severity Scale (FSS) at baseline and each follow up assessment. The FSS contains 9 questions relating to fatigue on a 7 point Likert scale. A 100mm visual analog scale will also accompany the FSS asking to "indicate on the line the point that best describes your fatigue during the past week", with 0 indicating "very alert" and 100 indicating "extremely fatigued". Additionally, a 100mm visual analog scale for fatigue will be measured before and after each exercise class with with 0 indicating "very alert" and 100 indicating "extremely fatigued".
Measured before and after each exercise class, and at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Physical Activity Level
Ramy czasowe: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Physical activity levels over the past 7 days will be quantified at baseline and at each follow up assessment using the International Physical Activity Questionnaire (IPAQ). The IPAQ looks at the duration of time spent doing moderate or vigorous activities across job-related physical activity, transportation physical activity, housework/house maintenance/caring for family and recreation/sport/leisure time physical activity.
Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
Impact of Hypermobility
Ramy czasowe: Measured at baseline and each follow up assessment at 4, 8, 12, 18, and 24 weeks.
The impacts of hypermobility on quality of life and physical function will be assessed using the Bristol Impact of Hypermobility (BiOH) questionnaire. The BiOH is scored from 0 to 360, with higher scores indicating greater severity.
Measured at baseline and each follow up assessment at 4, 8, 12, 18, and 24 weeks.
Quality of Life
Ramy czasowe: Measured at baseline and each follow up assessment at 4, 8, 12, 18, and 24 weeks.
Quality of life will also be measured using the RAND 36-item short form (SF-36). The SF-36 contains 36 multiple choice questions that are reported as 8 domains, including physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health.
Measured at baseline and each follow up assessment at 4, 8, 12, 18, and 24 weeks.
Knee Injury and Osteoarthritis Outcome Score
Ramy czasowe: Measured at baseline and at each follow up assessment at 4, 8, 12, 18, and 24 weeks.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire which measures quality of life and functional outcomes within domains of pain, symptoms, activities of daily living, sport/recreation, and knee-related quality of life. Each domain includes questions with 5-point Likert scales, including how often is your knee painful (never, monthly, weekly, daily, always), symptom severity (none, mild, moderate, severe, extreme), symptom presentations (never, rarely, sometimes, often, always), difficulty with activities (none, mild, moderate, severe, extreme), lifestyle modifications (not at all, mildly, moderately, severely, totally), and concerns (not at all, mildly, moderately, severely, extremely).
Measured at baseline and at each follow up assessment at 4, 8, 12, 18, and 24 weeks.
Knee Joint Proprioception
Ramy czasowe: Measured at baseline and at each follow up assessment at 4, 8, 12, 18, and 24 weeks.
Knee joint proprioception will be measured with a joint angle reproduction test using isokinetic dynamometer. The participant will be moved to a particular knee angle, then asked to reproduce this knee angle. The error in degrees between the original joint angle and the participant's reproduced joint angle will be calculated.
Measured at baseline and at each follow up assessment at 4, 8, 12, 18, and 24 weeks.
Work Status
Ramy czasowe: Measured at baseline and each follow up assessment at 4, 8, 12, 18 and 24 weeks.
Work Status will be reported at baseline and each follow up assessment as a multiple choice question with the following answers: not working by choice, part-time student, full-time student, retired, working full-time, working part-time, on temporary medical leave or short-term disability, on long-term disability (private, Canada Pension Plan Disability, or Workers' Compensation Board-Alberta income supplementation), other (please specify).
Measured at baseline and each follow up assessment at 4, 8, 12, 18 and 24 weeks.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Calgary

Śledczy

  • Główny śledczy: Ranita Manocha, University Of Calgary

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 maja 2027

Ukończenie studiów (Szacowany)

1 sierpnia 2027

Daty rejestracji na studia

Pierwszy przesłany

29 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 maja 2026

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • REB26-0442

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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