Hamstring Strengthening in Hypermobile Conditions
29 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ranita Manocha
- Número de teléfono: 4039444224
- Correo electrónico: bettermobilitylab@ucalgary.ca
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2N 4N1
- University of Calgary - Foothills Campus
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Contacto:
- Ranita Manocha
- Correo electrónico: bettermobilitylab@ucalgary.ca
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Investigador principal:
- Ranita Manocha, MD, MSc
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Knee Joint Laxity
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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.
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Knee Joint Stiffness
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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.
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Isokinetic eccentric knee flexion strength
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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.
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Isokinetic concentric knee flexion strength
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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.
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Hamstrings:Quadriceps Co-Activation
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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.
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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6-Minute Walk Test
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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.
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Pain Severity Score
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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.
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Safety of the Intervention
Periodo de tiempo: Monitored throughout the study from baseline to 24 weeks.
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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.
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Monitored throughout the study from baseline to 24 weeks.
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Tolerability of the Intervention
Periodo de tiempo: Monitored throughout the study, from baseline to week 24.
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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.
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Monitored throughout the study, from baseline to week 24.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acceptability of the Intervention
Periodo de tiempo: Measured at the follow up visits for week 12, 18, and 24.
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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.
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Measured at the follow up visits for week 12, 18, and 24.
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Adherence and Maintenance of Exercises
Periodo de tiempo: Measured at follow up visits for week 12, 18, and 24.
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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.
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Measured at follow up visits for week 12, 18, and 24.
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Knee Joint Range of Motion
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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.
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Isometric knee flexion and extension strength
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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.
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Stair Climb Test
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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.
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Pain Interference Score
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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.
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Knee Pain
Periodo de tiempo: Measured before and after each exercise class, and at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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".
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Measured before and after each exercise class, and at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Kinesiophobia
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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").
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Fatigue
Periodo de tiempo: Measured before and after each exercise class, and at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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".
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Measured before and after each exercise class, and at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Physical Activity Level
Periodo de tiempo: Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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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.
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Measured at all 6 outcome assessments (baseline, 4, 8, 12, 18, and 24 weeks).
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Impact of Hypermobility
Periodo de tiempo: Measured at baseline and each follow up assessment at 4, 8, 12, 18, and 24 weeks.
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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.
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Measured at baseline and each follow up assessment at 4, 8, 12, 18, and 24 weeks.
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Quality of Life
Periodo de tiempo: Measured at baseline and each follow up assessment at 4, 8, 12, 18, and 24 weeks.
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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.
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Measured at baseline and each follow up assessment at 4, 8, 12, 18, and 24 weeks.
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Knee Injury and Osteoarthritis Outcome Score
Periodo de tiempo: Measured at baseline and at each follow up assessment at 4, 8, 12, 18, and 24 weeks.
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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).
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Measured at baseline and at each follow up assessment at 4, 8, 12, 18, and 24 weeks.
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Knee Joint Proprioception
Periodo de tiempo: Measured at baseline and at each follow up assessment at 4, 8, 12, 18, and 24 weeks.
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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.
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Measured at baseline and at each follow up assessment at 4, 8, 12, 18, and 24 weeks.
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Work Status
Periodo de tiempo: Measured at baseline and each follow up assessment at 4, 8, 12, 18 and 24 weeks.
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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).
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Measured at baseline and each follow up assessment at 4, 8, 12, 18 and 24 weeks.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ranita Manocha, University Of Calgary
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de mayo de 2027
Finalización del estudio (Estimado)
1 de agosto de 2027
Fechas de registro del estudio
Enviado por primera vez
29 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades Articulares
- Enfermedades Genéticas Congénitas
- Enfermedades del tejido conectivo
- Enfermedades hematológicas
- Enfermedades de la piel
- Anomalías congénitas
- Trastornos hemostáticos
- Trastornos hemorrágicos
- Enfermedades De La Piel Genéticas
- Anomalías de la piel
- Enfermedades del colágeno
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Comportamiento
- Enfermedades de la piel y del tejido conectivo
- Enfermedades hemic y linfáticas
- Síndrome de Ehlers-Danlos
- Inestabilidad conjunta
- Actividad del motor
- Síndrome de Ehlers-Danlos tipo 3
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Ejercicio
Otros números de identificación del estudio
- REB26-0442
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .