Hamstring Strengthening in Hypermobile Conditions
2026년 5월 29일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ranita Manocha
- 전화번호: 4039444224
- 이메일: bettermobilitylab@ucalgary.ca
연구 장소
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Alberta
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Calgary, Alberta, 캐나다, T2N 4N1
- University of Calgary - Foothills Campus
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연락하다:
- Ranita Manocha
- 이메일: bettermobilitylab@ucalgary.ca
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수석 연구원:
- Ranita Manocha, MD, MSc
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Knee Joint Laxity
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Knee Joint Stiffness
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acceptability of the Intervention
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ranita Manocha, University Of Calgary
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2027년 5월 1일
연구 완료 (추정된)
2027년 8월 1일
연구 등록 날짜
최초 제출
2026년 5월 29일
QC 기준을 충족하는 최초 제출
2026년 5월 29일
처음 게시됨 (실제)
2026년 6월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 29일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- REB26-0442
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .