Delayed Onset Muscle SorenessNCT04755608
The Effect of Low-Intensity Resistance Exercise Training
A study testing Low Intensity Exercises with Blood Flow Restriction and High Intensity Resistant Exercise in people with Delayed Onset Muscle Soreness, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
It was to compare the effect of low-load resistance training with blood flow restriction (LL-BFR) and high-intensity resistance training (HI-RT) on muscle strength, endurance and volume, functional performance, and delayed onset muscle soreness (DOMS). The study included 13 young women. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness
- What is being tested?
- Low Intensity Exercises with Blood Flow Restriction and High Intensity Resistant Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2019to 1 Aug 2020
- 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 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-26,
- Do not have a chronic disease history and do not use medication,
- Female individuals were included.
Who cannot join
- People who made resisted exercise in the last 6 months,
- Smoker,
- BMI above 30 kg / m2,
- Individuals with hypertension were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University and Health Sciences Physical Therapy and Rehabilitation
Istanbul, Uskudar, 34668
About this study
Official title: The Effect OfF Low-Intensity Resistance Exercise Training Combined With Blood Flow Restruction On Triceps Brachii Muscle Volume And Performance
It was to compare the effect of low-load resistance training with blood flow restriction (LL-BFR) and high-intensity resistance training (HI-RT) on muscle strength, endurance and volume, functional performance, and delayed onset muscle soreness (DOMS).
The study included 13 young women. It is a controlled study designed for individuals to perform two different exercise protocols unilaterally. The persons were randomly allocated into two groups as LI- BFR (Group I, n = 13) and HI-RT (Group II, n = 13). Both groups received training for 6 weeks and 3 days a week. Blood flow restriction was performed only in group I.
Read the detailed description
Both sides triceps muscle thickness, triceps and biceps strength and endurance, functional performances (upper extremity Y balance test (UQYBT)), delayed-onset muscle soreness (DOMS) were evaluated before and after training.
- Conditions
- Delayed Onset Muscle Soreness
- Being tested
- Low Intensity Exercises with Blood Flow Restriction, High Intensity Resistant Exercise
- Keywords
- muscle hypertrophy, triceps brachii, muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Exercises with Blood Flow RestrictionOther
In the exercise protocol, people exercised resistance between 20% and 30% of 1 MaxRepetition with free weight. In addition, blood flow was restricted in 70% of the arterial occlusion pressure of the individual with the help of a cuff during exercise.
High Intensity Resistant ExerciseOther
People included in the study did resistance exercise with free weight at 70-80% of 1 MT.
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity Blood Flow Restriction Group | Experimental | Not described Receives: Other: Low Intensity Exercises with Blood Flow Restriction |
| High Intensity Resistant Training Group | Active comparator | Not described Receives: Other: High Intensity Resistant Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
triceps muscle thickness
Triceps brachial (TB) long head thickness was measured using the Esaote mylab C series ultrasound device.
Measured: 6 weeks
triceps and biceps strength
Triceps brachial muscle strength was evaluated with an isokinetic dynamometer (Cybex HUMAC / NORM, CSMI, 2004). Isometric muscle strength measurement was performed at the beginning and end of the study at angular velocities of 0-150 ° elbow range, 60 ° / s (strength measurement)
Measured: 6 weeks
triceps and biceps endurance
Triceps brachial muscle strength was evaluated with an isokinetic dynamometer (Cybex HUMAC / NORM, CSMI, 2004). Isometric muscle strength measurement was performed at the beginning and end of the study at angular velocities of 0-150 ° elbow range, 180 ° / s (endurance measurement).
Measured: 6 weeks
functional performances
Upper Extremity Y Balance Test
Measured: 6 weeks
delayed-onset muscle soreness
Visual Analog Scale
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 posted16 Feb 2021
- Study start1 Dec 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Onset Muscle SorenessStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Self Controlled Randomised Trial
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Serdar Atalay, Saglik Bilimleri Universitesi
- Investigators
- Yunus Emre Tütüneken, MSc, Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755608
- Sponsor's protocol ID
- 46418926-19-138
- Status last verified
- Feb 2021
- First submitted
- 30 Jan 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect OfF Low-Intensity Resistance Exercise Training Combined With Blood Flow Restruction On Triceps Brachii Muscle Volume And Performance
- ClinicalTrials.gov ID
- NCT04755608
- Acronym / sponsor ID
- 46418926-19-138
- Conditions
- Delayed Onset Muscle Soreness
- Keywords
- muscle hypertrophy, triceps brachii, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 16 Feb 2021 (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.
It was to compare the effect of low-load resistance training with blood flow restriction (LL-BFR) and high-intensity resistance training (HI-RT) on muscle strength, endurance and volume, functional performance, and delayed onset muscle soreness (DOMS).
The study included 13 young women. It is a controlled study designed for individuals to perform two different exercise protocols unilaterally. The persons were randomly allocated into two groups as LI- BFR (Group I, n = 13) and HI-RT (Group II, n = 13). Both groups received training for 6 weeks and 3 days a week. Blood flow restriction was performed only in group I.
Detailed description
Both sides triceps muscle thickness, triceps and biceps strength and endurance, functional performances (upper extremity Y balance test (UQYBT)), delayed-onset muscle soreness (DOMS) were evaluated before and after training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Self Controlled Randomised Trial
| Arm | Type | Receives |
|---|---|---|
| Low Intensity Blood Flow Restriction Group | Experimental | Other: Low Intensity Exercises with Blood Flow Restriction |
| High Intensity Resistant Training Group | Active comparator | Other: High Intensity Resistant Exercise |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between the ages of 18-26,
- Do not have a chronic disease history and do not use medication,
- Female individuals were included.
Key exclusion criteria (4 listed)
- People who made resisted exercise in the last 6 months,
- Smoker,
- BMI above 30 kg / m2,
- Individuals with hypertension were excluded.
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 |
|---|---|---|
| Low Intensity Exercises with Blood Flow RestrictionIn the exercise protocol, people exercised resistance between 20% and 30% of 1 MaxRepetition with free weight. In addition, blood flow was restricted in 70% of the arterial occlusion pressure of the individual with the help of a cuff during exercise. | Other | Low Intensity Blood Flow Restriction Group |
| High Intensity Resistant ExercisePeople included in the study did resistance exercise with free weight at 70-80% of 1 MT. | Other | High Intensity Resistant Training Group |
Primary outcome
triceps muscle thickness
Time frame: 6 weeks
Triceps brachial (TB) long head thickness was measured using the Esaote mylab C series ultrasound device.
triceps and biceps strength
Time frame: 6 weeks
Triceps brachial muscle strength was evaluated with an isokinetic dynamometer (Cybex HUMAC / NORM, CSMI, 2004). Isometric muscle strength measurement was performed at the beginning and end of the study at angular velocities of 0-150 ° elbow range, 60 ° / s (strength measurement)
triceps and biceps endurance
Time frame: 6 weeks
Triceps brachial muscle strength was evaluated with an isokinetic dynamometer (Cybex HUMAC / NORM, CSMI, 2004). Isometric muscle strength measurement was performed at the beginning and end of the study at angular velocities of 0-150 ° elbow range, 180 ° / s (endurance measurement).
functional performances
Time frame: 6 weeks
Upper Extremity Y Balance Test
delayed-onset muscle soreness
Time frame: 6 weeks
Visual Analog Scale
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 16 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Delayed Onset Muscle Soreness
Recruiting
Shower Gel and Participant-Reported Post-Exercise Soreness in Regular Exercisers
Post-Exercise Recovery, Muscle Soreness
Recruiting
Mineral-Infused Clothing for Recovery From Muscle Soreness and Muscle Damage After Exercise
Delayed Onset Muscle Soreness, Exercise-Induced Muscle Damage
Not yet recruiting
Clinical and MRI Characteristics of Delayed Onset Muscle Soreness (DOMS) of the Shoulder Rotator Muscles Induced by Eccentric Exercise: An Exploratory Prospective Experimental Study
Delayed Onset Muscle Soreness Experimentally Induced
Recruiting
Effects of Kinesio Tape on Delayed Onset Muscle Soreness
Delayed Onset Muscle Soreness
Not yet recruiting
Therapeutic Ultrasound for Muscle Recovery After Muscle Fatigue Exercise
Muscle Fatigue (C23.888.592.612.612), Delayed Onset Muscle Soreness (DOMS)
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.
Yunus Emre Tütüneken, MSc principal investigator
Istinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Exercises with Blood Flow Restriction and High Intensity Resistant Exercise in people with Delayed Onset Muscle Soreness, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 3 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 16 Feb 2021. 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?
triceps muscle thickness (time frame: 6 weeks). The study lists 5 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 16 Feb 2021.