Basal measurements are taken in relation to the study variables. Immediately subjects perform eccentric exercise on right hamstrings to develop delayed onset muscle soreness (DOMS).
Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from DOMS.
| Condition or disease |
|---|
| Pain, Muscle |
Basal measurements are taken in relation to the study variables.
The variables are:
Immediately subjects perform eccentric exercise on right hamstrings to develop DOMS (delay onset muscle soreness).
Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from DOMS.
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 24 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 7 Days |
| Official Title: | Temporal Relationship in Recovery of Muscular Pain, Functional Variables and Normal Gait Pattern in an Experimental Muscular Pain Model in Hamstrings |
| Actual Study Start Date : | October 15, 2018 |
| Actual Primary Completion Date : | August 31, 2019 |
| Actual Study Completion Date : | August 31, 2019 |
Changes in range of motion (°; degrees) will be assessed in both sides using the active knee extension (AKE) test.
AKE test: subject is lying prone with hip and knee flexed at 90°. Then, maximal knee extension is performed.
Two questionnaires (Modified 7-item Likert Scales) are filled up by the subject to show subjective perception of pain related to movement along the recovery period.
Scale of pain intensity, from 0 (no pain) to 6 (higher pain intensity). Scale of functional impairment, from 0 (no impairment) to 6 (higher impairment).
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| Spain | |
| Universidad San Jorge | |
| Villanueva De Gállego, Zaragoza, Spain, 50830 | |
| Study Director: | Víctor Doménech, MSc | Universidad San Jorge |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 6, 2019 | ||||
| First Posted Date | May 8, 2019 | ||||
| Last Update Posted Date | November 10, 2020 | ||||
| Actual Study Start Date | October 15, 2018 | ||||
| Actual Primary Completion Date | August 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Changes in spatio temporal parameters of gait [ Time Frame: Baseline, 48 hours, 96 hours, 1 week ] Changes in spatio temporal parameters of gait over a treadmill will be measurement using an optical measurement system consisting of a transmitting and receiving bar (OptoGait System).
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| Original Primary Outcome Measures |
Changes in spatio temporal parameters of gait [ Time Frame: Baseline, 48 hours, 96 hours, 1 week ] Changes in spatio temporal parameters of gait over a treadmill will be measurement using OptoGait System (an optical measurement system consisting of a transmitting and receiving bar).
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| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Temporal Relationship in Recovery of Muscular Pain and Functional Variables in an Experimental Muscular Pain Model in Hamstrings | ||||
| Official Title | Temporal Relationship in Recovery of Muscular Pain, Functional Variables and Normal Gait Pattern in an Experimental Muscular Pain Model in Hamstrings | ||||
| Brief Summary |
Basal measurements are taken in relation to the study variables. Immediately subjects perform eccentric exercise on right hamstrings to develop delayed onset muscle soreness (DOMS). Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from DOMS. |
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| Detailed Description |
Basal measurements are taken in relation to the study variables. The variables are:
Immediately subjects perform eccentric exercise on right hamstrings to develop DOMS (delay onset muscle soreness). Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from DOMS. |
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| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 7 Days | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Non sedentary healthy men | ||||
| Condition | Pain, Muscle | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
24 | ||||
| Original Estimated Enrollment |
20 | ||||
| Actual Study Completion Date | August 31, 2019 | ||||
| Actual Primary Completion Date | August 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 45 Years (Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03942562 | ||||
| Other Study ID Numbers | PI18/208 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Universidad San Jorge | ||||
| Study Sponsor | Universidad San Jorge | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Universidad San Jorge | ||||
| Verification Date | November 2020 | ||||