HypertrophyNCT04750694
High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players
A study testing Resistance training in people with Hypertrophy, run by Department of Public Health, Denmark at 1 site in Denmark.
Trial summary
Purpose of the study is: to investigate the effects of 8 weeks intervention of high intensity resistance training(HIRT) combined with Blood Flow Restricted Exercise (BFRE) compared to high intensity resistance training alone. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophy
- What is being tested?
- Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2020to 1 Nov 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >= 18 years
- Ds
- Minimum of 2 years of resistance training experience
- >< Two resistance training sessions each week
- >< three handball sessions each week
- No injuries that prevent participants to perform test of maximal muscle strength
- No injuries, that affects the muscle strength or the ability to train
Who cannot join
- Elevated blood pressure (>140/90)
- Anabolic steroids or prescription-only medical products with know or potential effect on muscle hypertrophy
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dept. of Public Health
Aarhus, 8000
Simon Lønbro, PhD, 21600410, loenbro@ph.au.dk
Esben Madsen, MSc student
About this study
Purpose of the study is: to investigate the effects of 8 weeks intervention of high intensity resistance training(HIRT) combined with Blood Flow Restricted Exercise (BFRE) compared to high intensity resistance training alone.
Detailed Description: 30 elite handball players will be randomized into 2 groups of 15 participants each. Participants will be evaluated in the week before and the week after an 8-weeks training intervention with 2 weekly sessions. Based on their baseline muscle strength the participants will be randomized into two groups: HIRT-BFRE or HIRT-HIRT. Participants in both groups will perform a full-body training programme of HIRT. After the Full-body programme, Back squat exercise with low intensity and Blood flow restriction will be performed to the HIRT-BFRE group and back squat exercise with high intensity without blood flow restriction will be performed by HIRT-HIRT. Evaluation protocol includes: muscle strength measurement with 1 repetition maximum of Back squat and knee extension, muscle mass with Dual-Energy X-ray absorptiometry, muscle thickness of the thigh with ultra sound measurement, vertical jump height with linear Encoder, sprint performance with 30m sprint time.
- Conditions
- Hypertrophy
- Being tested
- Resistance training
- Keywords
- The focus is blood flow restricted exercise
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
A full-training programme with high intensity followed by back squat exercise with blood flow restriction. Inflatable cuffs will be placed proximally on both thighs. The cuff pressure will be 50% of individual arterial occlusion pressure and will be maintained during the rest intervals. Participants will perform 30, 15, 15 and 15 repetitions of 30% of 1 Repetition Maximum. Totally 75 repetitions will be performed. 45 seconds rest interval between sets will be given.
| Study group | Role | What they receive |
|---|---|---|
| RT + BFRE | Experimental | High intensity Resistance training combined with Blood Flow Receives: Behavioral: Resistance training |
| RT | Active comparator | Resistance training alone Receives: Behavioral: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal Muscle Strength
Change in 1 RM (repetition maximum) muscle strength in back squat
Measured: Baseline measurements at week 1, after four weeks of exercise at week 5 and post intervention at week 10.
Secondary outcomes (1)
Change in Lean body mass
Change in lean body mass assessed by Dual Energy X-ray Absorptiometry
Measured: Baseline measurements at week 1 and post intervention at week 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Nov 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertrophyStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Public Health, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Lønbro, Department of Public Health, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750694
- Sponsor's protocol ID
- VEK ID 74646
- Status last verified
- Feb 2021
- First submitted
- 17 Nov 2020
- Last updated
- 11 Feb 2021
- 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 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players
- ClinicalTrials.gov ID
- NCT04750694
- Acronym / sponsor ID
- VEK ID 74646
- Conditions
- Hypertrophy
- Keywords
- The focus is blood flow restricted exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Department of Public Health, DenmarkUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 11 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.
Purpose of the study is: to investigate the effects of 8 weeks intervention of high intensity resistance training(HIRT) combined with Blood Flow Restricted Exercise (BFRE) compared to high intensity resistance training alone.
Detailed Description: 30 elite handball players will be randomized into 2 groups of 15 participants each. Participants will be evaluated in the week before and the week after an 8-weeks training intervention with 2 weekly sessions. Based on their baseline muscle strength the participants will be randomized into two groups: HIRT-BFRE or HIRT-HIRT. Participants in both groups will perform a full-body training programme of HIRT. After the Full-body programme, Back squat exercise with low intensity and Blood flow restriction will be performed to the HIRT-BFRE group and back squat exercise with high intensity without blood flow restriction will be performed by HIRT-HIRT. Evaluation protocol includes: muscle strength measurement with 1 repetition maximum of Back squat and knee extension, muscle mass with Dual-Energy X-ray absorptiometry, muscle thickness of the thigh with ultra sound measurement, vertical jump height with linear Encoder, sprint performance with 30m sprint time.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT + BFRE | Experimental | Behavioral: Resistance trainingHigh intensity Resistance training combined with Blood Flow |
| RT | Active comparator | Behavioral: Resistance trainingResistance training alone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age >= 18 years
- Ds
- Minimum of 2 years of resistance training experience
- >< Two resistance training sessions each week
- >< three handball sessions each week
Key exclusion criteria (2 listed)
- Elevated blood pressure (>140/90)
- Anabolic steroids or prescription-only medical products with know or potential effect on muscle hypertrophy
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 |
|---|---|---|
| Resistance trainingA full-training programme with high intensity followed by back squat exercise with blood flow restriction. Inflatable cuffs will be placed proximally on both thighs. The cuff pressure will be 50% of individual arterial occlusion pressure and will be maintained during the rest intervals. Participants will perform 30, 15, 15 and 15 repetitions of 30% of 1 Repetition Maximum. Totally 75 repetitions will be performed. 45 seconds rest interval between sets will be given. | Behavioural | RT, RT + BFRE |
Primary outcome
Change in Maximal Muscle Strength
Time frame: Baseline measurements at week 1, after four weeks of exercise at week 5 and post intervention at week 10.
Change in 1 RM (repetition maximum) muscle strength in back squat
1 secondary outcome
Change in Lean body mass
Time frame: Baseline measurements at week 1 and post intervention at week 10.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Hypertrophy, run by Department of Public Health, Denmark at 1 site in Denmark.
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 7 inclusion and 2 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 11 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 Denmark. 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 Simon Lønbro, PhD (004521600410, loenbro@ph.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximal Muscle Strength (time frame: Baseline measurements at week 1, after four weeks of exercise at week 5 and post intervention at week 10.). 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 11 Feb 2021.