Resistance TrainingNCT04670861
Effectiveness of Upper Quarter Biodex Training
A study testing Upper extremity Biodex balance training in people with Resistance Training, run by Cairo University.
Trial summary
Strength, and proprioception training of upper body following injuries is commonly recommended. However, there are no previous studies investigated the effects of Biodex balance training on the strength, stability and function of the upper quarter. Read more about this study
- Who is it for?
- Ages 19 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Resistance Training
- What is being tested?
- Upper extremity Biodex balance training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Apr 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 19 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy recreational male weightlifters aged between 19 and 25 years
Who cannot join
- if they took any hormonal supplements, participated in professional bodybuilding or power lifting competition, had shoulder pain or history of surgery or musculoskeletal injuries and if they dropped out their gym workout for more than three weeks in the last six months.
About this study
Official title: Innovative Use of Biodex Balance System to Improve Dynamic Stabilization and Function of Upper Quarter in Recreational Weightlifters: A Randomized Controlled Trial
Strength, and proprioception training of upper body following injuries is commonly recommended. However, there are no previous studies investigated the effects of Biodex balance training on the strength, stability and function of the upper quarter. So, the purpose of this study will investigate the effect of Biodex balance training on improving the strength, dynamic stability and function of the upper quarter in young recreational weightlifters.
Read the detailed description
Study design This is randomized controlled study. There are two groups classified randomly (group A \& group B); group (A); will receive upper extremities biodex balance training. 3 times/week for 8 weeks and group B that receive no treatment just assessment pre and post. Both groups will receive their regular weightlifting training exercises 4times/week.
Procedures Testing procedures Data collection from the testing procedures in the pre and post interventional phase will take place over two days to avoid the impact of fatigue on the participants' physical performance. In the first day, descriptive data will be measured and recorded for each subject including age, height, weight, upper extremity dominance (defined as the hand reported to be preferred for ball throwing). This will be followed by the upper quarter Y- balance (UQ-YBT) and the Dynamic limits of stability (DLOS) using the Biodex balance system. In the second day, data will be collected from the 2-minutes 90° push-up test and the one-arm hop test. The order of days and testing procedures will be randomized for all participants.
Training procedure Total number of 24 training sessions will be scheduled to the participants in group A over a period of eight weeks (three sessions/week). The Rating of perceived exertion (RPE) or Modified Borg scale (MBS) was used to monitor and guide exercise intensity. The scale allowed participants to subjectively rate their level of exertion during training. It starts at number 0 where training is causing no breathing difficulty at all and progress through to number 10 where breathing difficulty is maximal. Training will start with the current level of balance of each participant at which he reports exertion level of ≥ 5 based on modified Borg scale and progressed towards the more difficult ones. The Biodex display screen will be connected to a computer screen that will be positioned at a level to allow visual feedback to the participants during training The transition from one level to the more difficult one will be based on composite score of > 95% at the present level. Each training session will consist of three minutes training and one-minute rest, repeated for a total of 20 minutes.
- Conditions
- Resistance Training
- Being tested
- Upper extremity Biodex balance training
- Keywords
- Biodex, Balance, Functional test, weightlifters, upper quarter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper extremity Biodex balance trainingProcedure or surgery
The person assumes the prone plank posture with both hands poisoned in the area assigned for foot placement on the tilting balance platform. Using the four keypads, the person's left hand, left wrist, right hand and right wrist positions are entered into the system using the midline of the hand and the platform grid as reference points. The dot that appears on the position patient screen represents the person's segmental center of gravity.
During each trial test, the person should shift his weight to move the cursor from the center along a target path and back as quickly and with a little deviation as possible. The same process is repeated for each of the targets. Target paths activate in a random order.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Upper extremity Biodex balance training program three times/week for eight weeks in addition to regular weightlifting training exercises Receives: Procedure: Upper extremity Biodex balance training |
| control group | Active comparator | regular weightlifting training exercises Receives: Procedure: Upper extremity Biodex balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper quarter Y-balance
The YBT-UQ consists of a platform to which three wooden rulers are attached in the medial, inferolateral, and superolateral reach directions. Each of the posterior rulers is positioned 135ᵒ from the anterior one. The posterior rulers are separated by a 90ᵒ angle between them.
Measured: 8weeks (pre/post)
Biodex limits of stability
Dynamic stabilization of the upper quarter assessment and training was provided using Biodex SD system (Biodex, Inc., Shirley, NY, USA) to measure the composite score of the limits of stability (LOS). The system has a moveable multiaxial circular balance platform which can provide up to 20° of surface tilt within a 360° range of motion. The BBS is reported to be valid and reliable for balance assessment and treatment
Measured: 8weeks (pre/post)
Secondary outcomes (2)
Two minutes (2-min) 90° push-up
The exercise was performed on a flat, stable surface, hands placed slightly wider than shoulder-width apart, and fingers pointed forward. The participant "begins" the push-up by bending the elbows and lowering the body as a single unit until the upper arms are at least parallel to the ground (90° push-up) and then return to the starting position by raising the entire body until full extension of the arms. The aim of this test is to perform the maximum number of repetitions in two minutes
Measured: 8weeks (pre/post)
One-arm hop
The subjects were instructed to perform two sets of 10 standard 2-hand push-ups with 2-minute rest period in-between as warming up. This was followed by familiarization trials of the one arm hop test with the dominant and nondominant upper extremities. The subject first watched an instructional video depicting the one-arm hop test.
Measured: 8weeks (pre/post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study startMar 2021 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance TrainingStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Almaz Abdel-Aziem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670861
- Sponsor's protocol ID
- PT. REC.012.002982
- Status last verified
- Feb 2021
- First submitted
- 10 Dec 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Use of Biodex Balance System to Improve Dynamic Stabilization and Function of Upper Quarter in Recreational Weightlifters: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04670861
- Acronym / sponsor ID
- PT. REC.012.002982
- Conditions
- Resistance Training
- Keywords
- Biodex, Balance, Functional test, weightlifters, upper quarter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 17 Dec 2020 (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.
Strength, and proprioception training of upper body following injuries is commonly recommended. However, there are no previous studies investigated the effects of Biodex balance training on the strength, stability and function of the upper quarter. So, the purpose of this study will investigate the effect of Biodex balance training on improving the strength, dynamic stability and function of the upper quarter in young recreational weightlifters.
Detailed description
Study design This is randomized controlled study. There are two groups classified randomly (group A \& group B); group (A); will receive upper extremities biodex balance training. 3 times/week for 8 weeks and group B that receive no treatment just assessment pre and post. Both groups will receive their regular weightlifting training exercises 4times/week.
Procedures Testing procedures Data collection from the testing procedures in the pre and post interventional phase will take place over two days to avoid the impact of fatigue on the participants' physical performance. In the first day, descriptive data will be measured and recorded for each subject including age, height, weight, upper extremity dominance (defined as the hand reported to be preferred for ball throwing). This will be followed by the upper quarter Y- balance (UQ-YBT) and the Dynamic limits of stability (DLOS) using the Biodex balance system. In the second day, data will be collected from the 2-minutes 90° push-up test and the one-arm hop test. The order of days and testing procedures will be randomized for all participants.
Training procedure Total number of 24 training sessions will be scheduled to the participants in group A over a period of eight weeks (three sessions/week). The Rating of perceived exertion (RPE) or Modified Borg scale (MBS) was used to monitor and guide exercise intensity. The scale allowed participants to subjectively rate their level of exertion during training. It starts at number 0 where training is causing no breathing difficulty at all and progress through to number 10 where breathing difficulty is maximal. Training will start with the current level of balance of each participant at which he reports exertion level of ≥ 5 based on modified Borg scale and progressed towards the more difficult ones. The Biodex display screen will be connected to a computer screen that will be positioned at a level to allow visual feedback to the participants during training The transition from one level to the more difficult one will be based on composite score of > 95% at the present level. Each training session will consist of three minutes training and one-minute rest, repeated for a total of 20 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: Upper extremity Biodex balance trainingUpper extremity Biodex balance training program three times/week for eight weeks in addition to regular weightlifting training exercises |
| control group | Active comparator | Procedure: Upper extremity Biodex balance trainingregular weightlifting training exercises |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy recreational male weightlifters aged between 19 and 25 years
Key exclusion criteria (1 listed)
- if they took any hormonal supplements, participated in professional bodybuilding or power lifting competition, had shoulder pain or history of surgery or musculoskeletal injuries and if they dropped out their gym workout for more than three weeks in the last six months.
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 |
|---|---|---|
| Upper extremity Biodex balance trainingThe person assumes the prone plank posture with both hands poisoned in the area assigned for foot placement on the tilting balance platform. Using the four keypads, the person's left hand, left wrist, right hand and right wrist positions are entered into the system using the midline of the hand and the platform grid as reference points. The dot that appears on the position patient screen represents the person's segmental center of gravity. During each trial test, the person should shift his weight to move the cursor from the center along a target path and back as quickly and with a little deviation as possible. The same process is repeated for each of the targets. Target paths activate in a random order. | Procedure or surgery | control group, experimental group |
Primary outcome
Upper quarter Y-balance
Time frame: 8weeks (pre/post)
The YBT-UQ consists of a platform to which three wooden rulers are attached in the medial, inferolateral, and superolateral reach directions. Each of the posterior rulers is positioned 135ᵒ from the anterior one. The posterior rulers are separated by a 90ᵒ angle between them.
Biodex limits of stability
Time frame: 8weeks (pre/post)
Dynamic stabilization of the upper quarter assessment and training was provided using Biodex SD system (Biodex, Inc., Shirley, NY, USA) to measure the composite score of the limits of stability (LOS). The system has a moveable multiaxial circular balance platform which can provide up to 20° of surface tilt within a 360° range of motion. The BBS is reported to be valid and reliable for balance assessment and treatment
2 secondary outcomes
Two minutes (2-min) 90° push-up
Time frame: 8weeks (pre/post)
One-arm hop
Time frame: 8weeks (pre/post)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Upper extremity Biodex balance training in people with Resistance Training, run by Cairo University.
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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Upper quarter Y-balance (time frame: 8weeks (pre/post)). 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 Feb 2021; AzTrials last refreshed its copy on 31 Oct 2026.