Physical ExertionNCT03332693
Macroscopic and Molecular Changes in Knee Muscular - Tendon Unit in Response to Acute Resistant Load
A study testing Exercise and No exercise in people with Physical Exertion, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to determine whether individuals differ one from the other in their genetic, cellular, systemic, structural and functional response to acute exercise. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Exertion
- What is being tested?
- Exercise and No exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2017to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
Who cannot join
- Unhealthy adults
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Eias Kassem, MD, 972-50-6246882, eiask@hy.health.gov.il
About this study
The aim of this study is to determine whether individuals differ one from the other in their genetic, cellular, systemic, structural and functional response to acute exercise.
- Conditions
- Physical Exertion
- Being tested
- Exercise, No exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Leg weight raising
No exerciseOther
Volunteers will not participate in exercise
| Study group | Role | What they receive |
|---|---|---|
| No exercise | Active comparator | Volunteers will not participate in exercise Receives: Other: No exercise |
| Light exercise | Active comparator | Volunteers will participate in one short exercise Receives: Other: Exercise |
| Heavy exercise | Active comparator | Volunteers will participate in heavy exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic polymorphism changes in knee muscles
Genetic analysis will be made through a blood test and biopsy of knee muscle and results will be compared
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study startNov 2017 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ExertionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eias Kassem, MD, Study director, Hillel Yaffe Medical CenterSigal Ben Zaken, PhD, Principal investigator, Wingate Academic College for Physical Education and Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332693
- Sponsor's protocol ID
- HYMC-0058-16
- Status last verified
- Nov 2017
- First submitted
- 2 Nov 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macroscopic and Molecular Changes in Knee Muscular - Tendon Unit in Response to Acute Resistant Load
- ClinicalTrials.gov ID
- NCT03332693
- Acronym / sponsor ID
- HYMC-0058-16
- Conditions
- Physical Exertion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Nov 2017 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether individuals differ one from the other in their genetic, cellular, systemic, structural and functional response to acute exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No exercise | Active comparator | Other: No exerciseVolunteers will not participate in exercise |
| Light exercise | Active comparator | Other: ExerciseVolunteers will participate in one short exercise |
| Heavy exercise | Active comparator | Other: ExerciseVolunteers will participate in heavy exercise |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (1 listed)
- Unhealthy adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseLeg weight raising | Other | Heavy exercise, Light exercise |
| No exerciseVolunteers will not participate in exercise | Other | No exercise |
Primary outcome
Genetic polymorphism changes in knee muscles
Time frame: One year
Genetic analysis will be made through a blood test and biopsy of knee muscle and results will be compared
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eias Kassem, MD study director
Hillel Yaffe Medical Center
Sigal Ben Zaken, PhD principal investigator
Wingate Academic College for Physical Education and Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and No exercise in people with Physical Exertion, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eias Kassem, MD (972-6246882, eiask@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic polymorphism changes in knee muscles (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.