Muscle TightnessNCT03149133
Comparison of Occlusive and Classical Hypertrophy Training in Terms of Thickness and Stiffness of The Muscle
A study testing Heavy hypertrophy training and Light hypertrophy training in people with Muscle Tightness and Hypertrophy, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Occlusive or ischemic training is a type of strength training which is becoming more and more popular every day. The safety, efficacy and detailed description about the use of occlusive training is well documented in the literature. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Tightness, Hypertrophy, Occlusion Vein
- What is being tested?
- Heavy hypertrophy training and Light hypertrophy training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2017to 16 Aug 2017
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy recreational athletes
Who cannot join
- Any kind of systemic disorder
- Active or chronic infection
- Recent (last 6 months) musculoskeletal injury
- Performed strength training at last 72 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Occlusive and Classical Hypertrophy Training in Terms of Thickness and Stiffness of The Muscle, An Ultrasound-Based Study
Occlusive or ischemic training is a type of strength training which is becoming more and more popular every day. The safety, efficacy and detailed description about the use of occlusive training is well documented in the literature. However, the effects on hypertrophy and the stiffness of the muscle tissue are not studied. We aimed to measure these changes by ultrasound technology in a randomized controlled design.
Read the detailed description
Patients were randomized into classical hypertrophy and occlusive hypertrophy groups. The participants are free from any systemic disease, infection or recent injury. Both groups perform hypertrophy training with different intensities. The outcome measures are; thickness determined by B-mode ultrasound and stiffness by shear-wave elastography. Comparison of both groups will be made.
- Conditions
- Muscle Tightness, Hypertrophy, Occlusion Vein
- Being tested
- Heavy hypertrophy training, Light hypertrophy training
- Keywords
- Biomechanics, Strength training, Elastography, Ultrasound
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy hypertrophy trainingOther
Training with 75-80 % of 1-RM
Light hypertrophy trainingOther
Training with 35-50 % of 1-RM
| Study group | Role | What they receive |
|---|---|---|
| Classical Hypertrophy | Experimental | The classical hypertrophy group performs strength training with 75-80% of 1-Repetition Maximum. Receives: Other: Heavy hypertrophy training |
| Occlusive Training | Experimental | The occlusive hypertrophy group performs strength training with %35-50 of 1-Repetition Maximum. Receives: Other: Light hypertrophy training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness
The thickness of the biceps brachii muscle determined by B-mode ultrasound
Measured: 6 weeks
Stiffness
The stiffness of the biceps brachii muscle determined by ultrasound elastography
Measured: 6 weeks
Secondary outcomes (1)
Strength change
Arm flexion strength determined by isokinetic dynammometer
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start5 Apr 2017
- Primary completion15 Aug 2017
- Study completion16 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle TightnessStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÖMER BATIN GÖZÜBÜYÜK, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149133
- Sponsor's protocol ID
- 2016/248
- Status last verified
- Aug 2017
- First submitted
- 8 May 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Occlusive and Classical Hypertrophy Training in Terms of Thickness and Stiffness of The Muscle, An Ultrasound-Based Study
- ClinicalTrials.gov ID
- NCT03149133
- Acronym / sponsor ID
- 2016/248
- Conditions
- Muscle Tightness, Hypertrophy, Occlusion Vein
- Keywords
- Biomechanics, Strength training, Elastography, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 11 May 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.
Occlusive or ischemic training is a type of strength training which is becoming more and more popular every day. The safety, efficacy and detailed description about the use of occlusive training is well documented in the literature. However, the effects on hypertrophy and the stiffness of the muscle tissue are not studied. We aimed to measure these changes by ultrasound technology in a randomized controlled design.
Detailed description
Patients were randomized into classical hypertrophy and occlusive hypertrophy groups. The participants are free from any systemic disease, infection or recent injury. Both groups perform hypertrophy training with different intensities. The outcome measures are; thickness determined by B-mode ultrasound and stiffness by shear-wave elastography. Comparison of both groups will be made.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Classical Hypertrophy | Experimental | Other: Heavy hypertrophy trainingThe classical hypertrophy group performs strength training with 75-80% of 1-Repetition Maximum. |
| Occlusive Training | Experimental | Other: Light hypertrophy trainingThe occlusive hypertrophy group performs strength training with %35-50 of 1-Repetition Maximum. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy recreational athletes
Key exclusion criteria (4 listed)
- Any kind of systemic disorder
- Active or chronic infection
- Recent (last 6 months) musculoskeletal injury
- Performed strength training at last 72 hours
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 |
|---|---|---|
| Heavy hypertrophy trainingTraining with 75-80 % of 1-RM | Other | Classical Hypertrophy |
| Light hypertrophy trainingTraining with 35-50 % of 1-RM | Other | Occlusive Training |
Primary outcome
Thickness
Time frame: 6 weeks
The thickness of the biceps brachii muscle determined by B-mode ultrasound
Stiffness
Time frame: 6 weeks
The stiffness of the biceps brachii muscle determined by ultrasound elastography
1 secondary outcome
Strength change
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Muscle Tightness
Not yet recruiting
Mechanisms of Instrument-Assisted Soft Tissue Manipulation (IASTM) Force Dose-Response Effects in the Calf-Foot Region
Limited Ankle Dorsiflexion Due to Calf Muscle Tightness
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Not yet recruitingObservational study
Associations of Respiratory Muscle Strength and Trunk Muscle Mechanical Properties With Dynamic Postural Control
Postural Control, Muscle Tonus
Not yet recruiting
Local Vibration and Ankle Mobilization in Multiple Sclerosis
Multiple Sclerosis
Recruiting
Task-Oriented Upper Limb Training With Focal Vibration in Stroke
Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heavy hypertrophy training and Light hypertrophy training in people with Muscle Tightness and Hypertrophy, run by Istanbul University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 21 Aug 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 21 Aug 2017.