Physical PerformanceNCT04162886
Effects of Exercises on Physical Performance
A study testing Exercise in people with Physical Performance, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Aim: The aim of the study was to investigate the effects of thrower's ten exercises on the upper extremity performance in healthy sedentary individuals. Method: 36 healthy sedentary men and women aged 18-35 years will be included in the study. Subjects will be divided into two groups: exercise and control. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Performance
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCyprus
- Study dates
- 18 Nov 2019to 29 Jan 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women and men aged 18-35 years
Who cannot join
- Individuals with any neurological, orthopedic, cardiovascular, psychological problems,
- individuals who have a musculoskeletal injury in the last 1 year,
- individuals who doing regular physical activity/sport in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Thrower's Ten Exercises on Upper Extremity Strength, Power and Balance
Aim: The aim of the study was to investigate the effects of thrower's ten exercises on the upper extremity performance in healthy sedentary individuals.
Method: 36 healthy sedentary men and women aged 18-35 years will be included in the study. Subjects will be divided into two groups: exercise and control. The exercise group will be given Thrower's Ten training sessions 3 times a week over an 8-week period. Before and after the study, the subjects were tested for dynamic balance on the upper extremity with the Upper Limp Y balance test and for explosive power with the medicine ball throw test. Moreover, the strength of the shoulder rotator muscles was measured with an isokinetic dynamometer at a speed of 60º/sec.
- Conditions
- Physical Performance
- Being tested
- Exercise
- Keywords
- Exercise, power, muscle strength, balance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Thrower's ten exercises will given for 8 weeks, 3 days in a week.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Thrower's ten exercises will given for 8 weeks, 3 days in a week. Receives: Other: Exercise |
| Control Group | No intervention | Nothing given to the control group, will be told to continue their normal life for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of upper extremity strength assessed by an isokinetic dynamometer (Cybex Norm).
During all tests, participants will be encouraged verbally and visually. The forces of the upper extremity will be measured with an isokinetic dynamometer and an angular velocity of 5 repetitions at 60 ° / sec. Before the actual exam, subjects will allowed to make 3 trials. The test results will be recorded for the dominant side.
Measured: At the beginning and at the end of 8 weeks.
Secondary outcomes (1)
Change in the level of upper extremity explosive strength assessed by a seated medicine ball throw (SMBT) test.
A line will be drawn on a flat surface before testing. In the beginning, the subject will sits on this line with the head, back, and butt leaning against the wall and legs extending straight following the line. Hands were placed on the two sides of the wall without fingers touching. Upon the start command, the subject will lifted the ball to the chest and threw forwards as in a basketball shot. A 2 kg medicine ball will used in the test.
Measured: At the beginning and at the end of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start18 Nov 2019
- Primary completion22 Jan 2020
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical PerformanceStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Gökalp, Eastern Mediterranean University
- Investigators
- Berkiye Kırmızıgil, Asst. Prof, Study chair, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162886
- Sponsor's protocol ID
- 2017/45-03
- Status last verified
- Jan 2020
- First submitted
- 12 Nov 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gokalp O, Kirmizigil B. Effects of Thrower's Ten exercises on upper extremity performance: A randomized controlled study. Medicine (Baltimore). 2020 Oct 16;99(42):e22837. doi: 10.1097/MD.0000000000022837.
PubMed 33080765
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thrower's Ten Exercises on Upper Extremity Strength, Power and Balance
- ClinicalTrials.gov ID
- NCT04162886
- Acronym / sponsor ID
- 2017/45-03
- Conditions
- Physical Performance
- Keywords
- Exercise, power, muscle strength, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 14 Nov 2019 (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.
Aim: The aim of the study was to investigate the effects of thrower's ten exercises on the upper extremity performance in healthy sedentary individuals.
Method: 36 healthy sedentary men and women aged 18-35 years will be included in the study. Subjects will be divided into two groups: exercise and control. The exercise group will be given Thrower's Ten training sessions 3 times a week over an 8-week period. Before and after the study, the subjects were tested for dynamic balance on the upper extremity with the Upper Limp Y balance test and for explosive power with the medicine ball throw test. Moreover, the strength of the shoulder rotator muscles was measured with an isokinetic dynamometer at a speed of 60º/sec.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: ExerciseThrower's ten exercises will given for 8 weeks, 3 days in a week. |
| Control Group | No intervention | –Nothing given to the control group, will be told to continue their normal life for 8 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women and men aged 18-35 years
Key exclusion criteria (3 listed)
- Individuals with any neurological, orthopedic, cardiovascular, psychological problems,
- individuals who have a musculoskeletal injury in the last 1 year,
- individuals who doing regular physical activity/sport in the last 6 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 |
|---|---|---|
| ExerciseThrower's ten exercises will given for 8 weeks, 3 days in a week. | Other | Exercise Group |
Primary outcome
Change in the level of upper extremity strength assessed by an isokinetic dynamometer (Cybex Norm).
Time frame: At the beginning and at the end of 8 weeks.
During all tests, participants will be encouraged verbally and visually. The forces of the upper extremity will be measured with an isokinetic dynamometer and an angular velocity of 5 repetitions at 60 ° / sec. Before the actual exam, subjects will allowed to make 3 trials. The test results will be recorded for the dominant side.
1 secondary outcome
Change in the level of upper extremity explosive strength assessed by a seated medicine ball throw (SMBT) test.
Time frame: At the beginning and at the end of 8 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 30 Jan 2020.
- Derived from this study: PubMed 33080765Gokalp O, Kirmizigil B. Effects of Thrower's Ten exercises on upper extremity performance: A randomized controlled study. Medicine (Baltimore). 2020 Oct 16;99(42):e22837. doi: 10.1097/MD.0000000000022837.
- Individual participant dataSharing planned: Undecided
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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.
Berkiye Kırmızıgil, Asst. Prof study chair
Eastern Mediterranean 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 Exercise in people with Physical Performance, run by Eastern Mediterranean University at 1 site in Cyprus.
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 3 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 30 Jan 2020. 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 Cyprus. 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?
Change in the level of upper extremity strength assessed by an isokinetic dynamometer (Cybex Norm). (time frame: At the beginning and at the end of 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162886, which also lists 1 linked publication.
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 30 Jan 2020.