Premenopausal WomenNCT04809857
Effect of Plyometric Exercises in Premenopausal Women
A study testing Exercise in people with Premenopausal Women, run by Bezmialem Vakif University.
Trial summary
It was aimed to examine the effects of plyometric exercises on muscle strength in this study. 26 premenopausal women assigned to one of the three groups: Control Group (n=8), Plyometric Exercise Group (n=10) and Isokinetic Exercise Group (n=8). Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenopausal Women
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to May 2007
- 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 35 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal women aged 35-50 years
Who cannot join
- to have cardiovascular, musculoskeletal and neurologic disease
- have been involved in exercise studies within the last 6 months
- to being receive hormone replacement therapy
About this study
Official title: The Effect of Plyometric Exercises on Muscle Strength in Premenopausal Women
It was aimed to examine the effects of plyometric exercises on muscle strength in this study. 26 premenopausal women assigned to one of the three groups: Control Group (n=8), Plyometric Exercise Group (n=10) and Isokinetic Exercise Group (n=8). Muscle strength assessments, depression and anxiety inventories were performed baseline and after 6 weeks.
Read the detailed description
Depending on various factors, bone mass begins to decrease with aging and this may lead to the osteoporosis. Physical activity and regular exercise provides an increase in bone mineral density (BMD). It is mentioned that there are relationships between muscle strength and BMD and also muscle strength has positive effects on BMD. In the literature it is showed that postmenopausal women with weaker trunk muscle strength could have risk of osteoporosis.
Plyometric exercises are used to increase muscle strength. Physiological basis of plyometric exercise consist of stretch-shortening cycle and thus it is effective in increasing the force. At the same time, plyometric exercises have positive effects on BMD because of weight bearing exercises.
The aim of this study was to investigate the effects of plyometric exercises on hip and trunk muscle strength in premenopausal women.
Participants and Study Design: Twenty six sedentary premenopausal women aged 35-50 years participated this study. Participants were assigned into three groups: Plyometric Exercise Group (PG; n=10), Isokinetic Exercise Group (IG; n=8), Control Group (CG; n=8). Participants were informed about the procedures of the study and signed a written voluntary consent form in accordance with the Declaration of Helsinki. The study protocol was approved by the Ethical Committee of the Istanbul University Medical Faculty. Measurements and training sessions were performed in the Istanbul University Medical Faculty Sport Medicine Department's Laboratory.
Measurements: Muscle strength was determined by using a Cybex Norm isokinetic dynamometer (Cybex Humac Norm, USA). Range of motion was set from 10 degree extension to 40 degree flexion. Isokinetic concentric contraction strength was measured at angular velocity of 60 degree per second and 90 degree per second. Subjects performed 3 trials trunk flexion and extension contractions at minimal exertion and 4 test repetitions at maximal trunk flexion and extension.
The hip abduction adduction isokinetic testing was performed in side lying position. Hip muscle strength was measured at angular velocity of 30 degree per second. Range of motion was set from 10 degree adduction to 40 degree abduction. Subjects performed 4 trials at minimal exertion and 4 test repetitions. Dominant leg values were analyzed for hip. All subjects performed warm-up and stretching exercises before testing.
Beck Depression Inventory (BDI) and State-Trait Anxiety Inventory (STAI) were used to asses depression and anxiety conditions.
Interventions: The training sessions were performed three days a week for six weeks. All exercise sessions were supervised by a physiotherapist.
Each session was consisted of warm-up, plyometric exercises and cool-down periods in PG. The warm-up and cool-down periods were performed by walking on the treadmill and lower extremity stretching exercises. The plyometric exercise training period involved vertical jumping, forward and back jumping and lateral jumping. After fifth session the number of repetitions were increased depending of toleration of participants. After tenth session step bench jumping exercise and after fifteenth session diagonal jumping exercise were added and study was completed in eighteen session.
In IG, isokinetic exercises were performed by using a Cybex Norm isokinetic dynamometer with an incorporated trunk flexion/extension unit in a standing position. Range of motion was set from 10 degree extension to 40 degree flexion. Each session was consisted warm-up, isokinetic exercises and cool-down periods. Warm-up and cool-down periods were consisted trunk exercise and stretching. Isokinetic exercises were performed 7 repetitions at angular velocity of 90 degree per second , 6 repetitions at angular velocity of 75 degree per second and 5 repetitions at angular velocity of 60 degree per second.
Participants in CG were assessed baseline and at sixth week.
- Conditions
- Premenopausal Women
- Being tested
- Exercise
- Keywords
- Plyometric exercise, Isokinetic, Muscle strength, Premenopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Plyometric Exercise Group | Experimental | Plyometric exercise training 3 days a week for 6 weeks Receives: Other: Exercise |
| Isokinetic Exercise Group | Active comparator | Isokinetic exercise training 3 days a week for 6 weeks Receives: Other: Exercise |
| Control Group | No intervention | no exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic testing trunk flexion-extension
changes trunk flexion and extension muscle strength from baseline at 6 weeks
Measured: Six weeks
Isokinetic testing hip abduction-adduction
changes hip abduction and adduction muscle strength from baseline at 6 weeks
Measured: Six weeks
Secondary outcomes (2)
Beck Depression Inventory
changes inventory scores from baseline at 6 weeks
Measured: Six weeks
State Trait Anxiety Inventory
changes inventory scores from baseline at 6 weeks
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study startJan 2006
- Primary completionFeb 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenopausal WomenStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Kübra Alpay, Bezmialem Vakif University
- Investigators
- Safinaz Yildiz, Study director, Istanbul UniversityKubra Alpay, Principal investigator, Bezmialem Vakif UniversityTurker Sahinkaya, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809857
- Sponsor's protocol ID
- Kubra2
- Status last verified
- Mar 2021
- First submitted
- 17 Feb 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Plyometric Exercises on Muscle Strength in Premenopausal Women
- ClinicalTrials.gov ID
- NCT04809857
- Acronym / sponsor ID
- Kubra2
- Conditions
- Premenopausal Women
- Keywords
- Plyometric exercise, Isokinetic, Muscle strength, Premenopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- Jan 2006 (actual)
- Primary completion
- Feb 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 22 Mar 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 aimed to examine the effects of plyometric exercises on muscle strength in this study. 26 premenopausal women assigned to one of the three groups: Control Group (n=8), Plyometric Exercise Group (n=10) and Isokinetic Exercise Group (n=8). Muscle strength assessments, depression and anxiety inventories were performed baseline and after 6 weeks.
Detailed description
Depending on various factors, bone mass begins to decrease with aging and this may lead to the osteoporosis. Physical activity and regular exercise provides an increase in bone mineral density (BMD). It is mentioned that there are relationships between muscle strength and BMD and also muscle strength has positive effects on BMD. In the literature it is showed that postmenopausal women with weaker trunk muscle strength could have risk of osteoporosis.
Plyometric exercises are used to increase muscle strength. Physiological basis of plyometric exercise consist of stretch-shortening cycle and thus it is effective in increasing the force. At the same time, plyometric exercises have positive effects on BMD because of weight bearing exercises.
The aim of this study was to investigate the effects of plyometric exercises on hip and trunk muscle strength in premenopausal women.
Participants and Study Design: Twenty six sedentary premenopausal women aged 35-50 years participated this study. Participants were assigned into three groups: Plyometric Exercise Group (PG; n=10), Isokinetic Exercise Group (IG; n=8), Control Group (CG; n=8). Participants were informed about the procedures of the study and signed a written voluntary consent form in accordance with the Declaration of Helsinki. The study protocol was approved by the Ethical Committee of the Istanbul University Medical Faculty. Measurements and training sessions were performed in the Istanbul University Medical Faculty Sport Medicine Department's Laboratory.
Measurements: Muscle strength was determined by using a Cybex Norm isokinetic dynamometer (Cybex Humac Norm, USA). Range of motion was set from 10 degree extension to 40 degree flexion. Isokinetic concentric contraction strength was measured at angular velocity of 60 degree per second and 90 degree per second. Subjects performed 3 trials trunk flexion and extension contractions at minimal exertion and 4 test repetitions at maximal trunk flexion and extension.
The hip abduction adduction isokinetic testing was performed in side lying position. Hip muscle strength was measured at angular velocity of 30 degree per second. Range of motion was set from 10 degree adduction to 40 degree abduction. Subjects performed 4 trials at minimal exertion and 4 test repetitions. Dominant leg values were analyzed for hip. All subjects performed warm-up and stretching exercises before testing.
Beck Depression Inventory (BDI) and State-Trait Anxiety Inventory (STAI) were used to asses depression and anxiety conditions.
Interventions: The training sessions were performed three days a week for six weeks. All exercise sessions were supervised by a physiotherapist.
Each session was consisted of warm-up, plyometric exercises and cool-down periods in PG. The warm-up and cool-down periods were performed by walking on the treadmill and lower extremity stretching exercises. The plyometric exercise training period involved vertical jumping, forward and back jumping and lateral jumping. After fifth session the number of repetitions were increased depending of toleration of participants. After tenth session step bench jumping exercise and after fifteenth session diagonal jumping exercise were added and study was completed in eighteen session.
In IG, isokinetic exercises were performed by using a Cybex Norm isokinetic dynamometer with an incorporated trunk flexion/extension unit in a standing position. Range of motion was set from 10 degree extension to 40 degree flexion. Each session was consisted warm-up, isokinetic exercises and cool-down periods. Warm-up and cool-down periods were consisted trunk exercise and stretching. Isokinetic exercises were performed 7 repetitions at angular velocity of 90 degree per second , 6 repetitions at angular velocity of 75 degree per second and 5 repetitions at angular velocity of 60 degree per second.
Participants in CG were assessed baseline and at sixth week.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plyometric Exercise Group | Experimental | Other: ExercisePlyometric exercise training 3 days a week for 6 weeks |
| Isokinetic Exercise Group | Active comparator | Other: ExerciseIsokinetic exercise training 3 days a week for 6 weeks |
| Control Group | No intervention | –no exercise intervention |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Premenopausal women aged 35-50 years
Key exclusion criteria (3 listed)
- to have cardiovascular, musculoskeletal and neurologic disease
- have been involved in exercise studies within the last 6 months
- to being receive hormone replacement therapy
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 |
|---|---|---|
| Exercise | Other | Isokinetic Exercise Group, Plyometric Exercise Group |
Primary outcome
Isokinetic testing trunk flexion-extension
Time frame: Six weeks
changes trunk flexion and extension muscle strength from baseline at 6 weeks
Isokinetic testing hip abduction-adduction
Time frame: Six weeks
changes hip abduction and adduction muscle strength from baseline at 6 weeks
2 secondary outcomes
Beck Depression Inventory
Time frame: Six weeks
State Trait Anxiety Inventory
Time frame: Six 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 22 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Premenopausal Women
Not yet recruiting
Intermittent Walking Training and Cardiometabolic Health in Premenopausal and Postmenopausal Women
Cardiometabolic Health in Premenopausal and Postmenopausal Women
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.
Safinaz Yildiz study director
Istanbul University
Kubra Alpay principal investigator
Bezmialem Vakif University
Turker Sahinkaya study chair
Istanbul University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Premenopausal Women, run by Bezmialem Vakif 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 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 22 Mar 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?
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?
Isokinetic testing trunk flexion-extension (time frame: Six 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 22 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.