Hamstring Strengthening in Hypermobile Conditions
29 de maio de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
20
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Ranita Manocha
- Número de telefone: 4039444224
- E-mail: bettermobilitylab@ucalgary.ca
Locais de estudo
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Alberta
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Calgary, Alberta, Canadá, T2N 4N1
- University of Calgary - Foothills Campus
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Contato:
- Ranita Manocha
- E-mail: bettermobilitylab@ucalgary.ca
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Investigador principal:
- Ranita Manocha, MD, MSc
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
|
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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Knee Joint Laxity
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Knee Joint Stiffness
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Acceptability of the Intervention
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Ranita Manocha, University Of Calgary
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de junho de 2026
Conclusão Primária (Estimado)
1 de maio de 2027
Conclusão do estudo (Estimado)
1 de agosto de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
29 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de maio de 2026
Primeira postagem (Real)
4 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças musculoesqueléticas
- Doenças Vasculares
- Doenças cardiovasculares
- Doenças articulares
- Doenças Genéticas, Congênitas
- Doenças do Tecido Conjuntivo
- Doenças Hematológicas
- Doenças de pele
- Anomalias congénitas
- Distúrbios hemostáticos
- Distúrbios hemorrágicos
- Doenças de Pele Genéticas
- Anormalidades da pele
- Doenças do colágeno
- Doenças e Anormalidades Congênitas, Hereditárias e Neonatais
- Comportamento
- Doenças da Pele e do Tecido Conjuntivo
- Doenças hemic e linfáticas
- Síndrome de Ehlers-Danlos
- Instabilidade conjunta
- Atividade motora
- Síndrome de Ehlers-Danlos tipo 3
- Atividade motora
- Movimento
- Fenômenos fisiológicos musculoesqueléticos
- Fenômenos fisiológicos musculoesqueléticos e neurais
- Exercício
Outros números de identificação do estudo
- REB26-0442
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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