Postmenopausal SymptomsNCT04266067
PNF and Frenkel's Exercises for Postmenopausal Women
A study testing PNF exercise and Frenkel exercise in people with Postmenopausal Symptoms, run by Hilal Yeşil at 1 site in Turkey (Türkiye).
Trial summary
Postural stability is impaired due to the decrease in estrogen in the postmenopausal period, which may lead to disruption of balance and risk of falling. Our objective was to investigate the effects of PNF and Frenkel's exercises on balance, fall risk, and quality of life in postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Postmenopausal Symptoms
- What is being tested?
- PNF exercise and Frenkel exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 30 Aug 2019
- 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 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women aged between 50-80 years who can walk independently were included in the study
Who cannot join
- 1. Having diabetic retinopathy and nephropathy, 2. The presence of plantar ulcers, 3. Presence of coronary artery disease, 4. Presence of peripheral vascular disease, 5. Presence of vision disorders, 6. Having a history of use of assistive walking device, 7. Presence of severe neurological, muscular or rheumatologic disease, 8. History of alcohol use, 9. Having lower limb amputation, 10. Presence of dementia, 11. Having a malignancy history, 12. Having a hearing problem, 13. Using a drug affecting balance, 14. Patients included in regular exercise program, and 15. Presence of neurological diseases affecting balance (stroke, multiple sclerosis, Parkinson's disease, epilepsy, etc.).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hilal Yesil
Afyonkarahisar, Eyalet/Yerleşke, 0300
About this study
Official title: The Effects of PNF and Frenkel's Exercises on Balance, Fall Risk, and Quality of Life in Postmenopausal Women
Postural stability is impaired due to the decrease in estrogen in the postmenopausal period, which may lead to disruption of balance and risk of falling. Our objective was to investigate the effects of PNF and Frenkel's exercises on balance, fall risk, and quality of life in postmenopausal women.
Methods: Forty-eight postmenopausal women were randomized into PNF (n = 24) (5 days a week) and Frenkel (n = 24) (5 days a week as a home exercise program) exercise groups. Hand grip strength, quality of life (short form- 36), falling risk (Falls Risk of Older People-Community Setting [FROP-COM]), and balance (functional reach test [FRT], one - leg stand test [OLST], timed up and go test [TUG], and Berg balance scale [BBS]) of all patients were evaluated prior to treatment, and at 4th week follow-up. The treatment responses were evaluated at the beginning, and at the 4th week.
Read the detailed description
In this study, we aimed to investigate the effects of PNF and Frenkel's exercises on balance, fall risk, and quality of life in postmenopausal women.
Methods: Forty-eight postmenopausal women were randomized into PNF (n = 24) (5 days a week) and Frenkel (n = 24) (5 days a week as a home exercise program) exercise groups. Hand grip strength, quality of life (short form- 36), falling risk (Falls Risk of Older People-Community Setting [FROP-COM]), and balance (functional reach test [FRT], one - leg stand test [OLST], timed up and go test [TUG], and Berg balance scale [BBS]) of all patients were evaluated prior to treatment, and at 4th week follow-up. The treatment responses were evaluated at the beginning, and at the 4th week. A total of 13 patients (27.1%) had a history of falls in the last 6 months and 12 months. According to the intra-group assessment; there was a significant improvement in all parameters in PNF group (p<0.05). In Frenkel group, there was a significant improvement in all evaluations except the OLST (p=0.064), and the short form-36 mental health score (p=0.057). Among the groups; no significant difference was detected in terms of hand grip strength, FROP-COM, FRT and TUG scores (p > 0.05). The OLST and BBS scores was significantly higher in the PNF group (p=0.022, and p= 0.002, respectively). To conclude, PNF and Frenkel exercise programs had significant effects on balance parameters, risk of falling and quality of life in postmenopausal women. Frenkel home exercise program is cheaper, easier, and requires less manpower, therefore, we think that it may be more preferable in terms of improving balance and reducing fall risk in postmenopausal women.
- Conditions
- Postmenopausal Symptoms
- Being tested
- PNF exercise, Frenkel exercise
- Keywords
- PNF exercise, Frenkel exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF exerciseOther
Proprioceptive neuromuscular facilitation (PNF) is a form of neuromuscular retraining type containing the stimulation of sensory receptors to provide information about the body position and movement to facilitate the intended movement
Frenkel exerciseOther
The Frenkel exercises consist of a series of slow, repetitive movements performed in different positions while lying, sitting and standing.
| Study group | Role | What they receive |
|---|---|---|
| PNF exercise | Active comparator | In the PNF exercise group; exercises were performed in company with a physiotherapist 5 days a week (30 minutes ) for 4 weeks. Five specific techniques were applied to the patients: dynamic stabilization, rhythmic stabilization, combined isotonic contractions, and hold-relax active motion Receives: Other: PNF exercise |
| Frenkel exercise | Active comparator | In the Frenkel exercise group, Frenkel coordination exercises were given in home exercise program 5 days a week for 4 weeks.The physiotherapist demonstrated Frenkel exercises to them once. Receives: Other: Frenkel exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Falls Risk for Older People-Community Setting (FROP-COM) score at 4 th week.
FROP-COM); includes 13 fall risk factor sections. The sum of the individual scores provides a total fall risk score ranging between 0 and 60 and higher scores refer to higher risks. While scores between 0-20 are evaluated as low- moderate fall risk, those between 21-60 scores are evaluated as high fall risk
Measured: up to 4 weeks
Secondary outcomes (6)
change from baseline Functional reach test score at 4 th week
Functional reach test is a performance-based test measuring the maximum distance a person can reach while standing in a fixed position without losing balance, taking a step or touching a wall. The patients were asked to reach forward as far as possible without falling and stepping. The distance between the start and end positions was measured and recorded. Three trials were conducted and the average of the last two was noted .
Measured: up to 4 weeks
change from baseline one leg stand test score at 4 th week
One leg stand test; as the starting position, the patients were asked to stand in a relaxed way with their eyes open with evenly distributed weight on both feet. The patients were then asked to stand freely on one leg for as long as possible. The test was terminated after 30 seconds or when the patient's foot touched to the ground. Then, the time was recorded
Measured: up to 4 weeks
change from baseline timed up and go test score at 4 th week
Timed up and go test; the patient was asked to stand up while sitting in a chair, to walk to a line three meter away at a comfortable and safe speed and then return back and sit again on the chair. In this process, time was kept with stopwatch. In order to determine fall risk, a cut-off point of ≥13.5 seconds was used
Measured: up to 4 weeks
change from baseline berg balance scale score at 4 th week
Berg balance scale (BBS) is a scale consisting of 14 items. Each of these items is scored between 0 and 4. "0" indicates that the task cannot be done. As the score goes to 4, the patient completes the task independently. Total score range is between 0 and 56. Here, while 0 point reflect the worst balance, 56 points refer to the best balance
Measured: up to 4 weeks
change from baseline hand grip strength test score at 4 th week
Hand grip strength test; was evaluated with JAMAR dynamometer (BASELINE hydraulic hand dynamometer FEI White Plains, NY 10602 USA). The patients were asked to sit flat, hold their upper arm in a neutral position and keep their elbows at 90° flexion. The forearm was held in a neutral position and they were asked to hold their elbow in extension between 0 and 30°. The patient was then asked to grip the device with all of his/her strength.
Measured: up to 4 weeks
change from baseline short form 36 score at 4 th week
Short form (SF)- 36; is a generic scale frequently used to assess quality of life. SF-36 is composed of 36 items used in the calculation of 8 different scale scores and consists of the following eight subscales. While 0 point indicates the worst health status, 100 points signify best health status.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Aug 2018
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal SymptomsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hilal Yeşil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hilal Yeşil, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266067
- Sponsor's protocol ID
- HYSS2019
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 12 Feb 2020
- 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 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of PNF and Frenkel's Exercises on Balance, Fall Risk, and Quality of Life in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04266067
- Acronym / sponsor ID
- HYSS2019
- Conditions
- Postmenopausal Symptoms
- Keywords
- PNF exercise, Frenkel exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hilal YeşilUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 12 Feb 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.
Postural stability is impaired due to the decrease in estrogen in the postmenopausal period, which may lead to disruption of balance and risk of falling. Our objective was to investigate the effects of PNF and Frenkel's exercises on balance, fall risk, and quality of life in postmenopausal women.
Methods: Forty-eight postmenopausal women were randomized into PNF (n = 24) (5 days a week) and Frenkel (n = 24) (5 days a week as a home exercise program) exercise groups. Hand grip strength, quality of life (short form- 36), falling risk (Falls Risk of Older People-Community Setting [FROP-COM]), and balance (functional reach test [FRT], one - leg stand test [OLST], timed up and go test [TUG], and Berg balance scale [BBS]) of all patients were evaluated prior to treatment, and at 4th week follow-up. The treatment responses were evaluated at the beginning, and at the 4th week.
Detailed description
In this study, we aimed to investigate the effects of PNF and Frenkel's exercises on balance, fall risk, and quality of life in postmenopausal women.
Methods: Forty-eight postmenopausal women were randomized into PNF (n = 24) (5 days a week) and Frenkel (n = 24) (5 days a week as a home exercise program) exercise groups. Hand grip strength, quality of life (short form- 36), falling risk (Falls Risk of Older People-Community Setting [FROP-COM]), and balance (functional reach test [FRT], one - leg stand test [OLST], timed up and go test [TUG], and Berg balance scale [BBS]) of all patients were evaluated prior to treatment, and at 4th week follow-up. The treatment responses were evaluated at the beginning, and at the 4th week. A total of 13 patients (27.1%) had a history of falls in the last 6 months and 12 months. According to the intra-group assessment; there was a significant improvement in all parameters in PNF group (p<0.05). In Frenkel group, there was a significant improvement in all evaluations except the OLST (p=0.064), and the short form-36 mental health score (p=0.057). Among the groups; no significant difference was detected in terms of hand grip strength, FROP-COM, FRT and TUG scores (p > 0.05). The OLST and BBS scores was significantly higher in the PNF group (p=0.022, and p= 0.002, respectively). To conclude, PNF and Frenkel exercise programs had significant effects on balance parameters, risk of falling and quality of life in postmenopausal women. Frenkel home exercise program is cheaper, easier, and requires less manpower, therefore, we think that it may be more preferable in terms of improving balance and reducing fall risk in postmenopausal women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF exercise | Active comparator | Other: PNF exerciseIn the PNF exercise group; exercises were performed in company with a physiotherapist 5 days a week (30 minutes ) for 4 weeks. Five specific techniques were applied to the patients: dynamic stabilization, rhythmic stabilization, combined isotonic contractions, and hold-relax active motion |
| Frenkel exercise | Active comparator | Other: Frenkel exerciseIn the Frenkel exercise group, Frenkel coordination exercises were given in home exercise program 5 days a week for 4 weeks.The physiotherapist demonstrated Frenkel exercises to them once. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women aged between 50-80 years who can walk independently were included in the study
Key exclusion criteria (1 listed)
- 1. Having diabetic retinopathy and nephropathy, 2. The presence of plantar ulcers, 3. Presence of coronary artery disease, 4. Presence of peripheral vascular disease, 5. Presence of vision disorders, 6. Having a history of use of assistive walking device, 7. Presence of severe neurological, muscular or rheumatologic disease, 8. History of alcohol use, 9. Having lower limb amputation, 10. Presence of dementia, 11. Having a malignancy history, 12. Having a hearing problem, 13. Using a drug affecting balance, 14. Patients included in regular exercise program, and 15. Presence of neurological diseases affecting balance (stroke, multiple sclerosis, Parkinson's disease, epilepsy, etc.).
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 |
|---|---|---|
| PNF exerciseProprioceptive neuromuscular facilitation (PNF) is a form of neuromuscular retraining type containing the stimulation of sensory receptors to provide information about the body position and movement to facilitate the intended movement | Other | PNF exercise |
| Frenkel exerciseThe Frenkel exercises consist of a series of slow, repetitive movements performed in different positions while lying, sitting and standing. | Other | Frenkel exercise |
Primary outcome
Change from baseline Falls Risk for Older People-Community Setting (FROP-COM) score at 4 th week.
Time frame: up to 4 weeks
FROP-COM); includes 13 fall risk factor sections. The sum of the individual scores provides a total fall risk score ranging between 0 and 60 and higher scores refer to higher risks. While scores between 0-20 are evaluated as low- moderate fall risk, those between 21-60 scores are evaluated as high fall risk
6 secondary outcomes
change from baseline Functional reach test score at 4 th week
Time frame: up to 4 weeks
change from baseline one leg stand test score at 4 th week
Time frame: up to 4 weeks
change from baseline timed up and go test score at 4 th week
Time frame: up to 4 weeks
change from baseline berg balance scale score at 4 th week
Time frame: up to 4 weeks
change from baseline hand grip strength test score at 4 th week
Time frame: up to 4 weeks
change from baseline short form 36 score at 4 th week
Time frame: up to 4 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 12 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Postmenopausal Symptoms
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruitingPhase 4
Migraine Menopause Study
Migraine, Menopausal
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF exercise and Frenkel exercise in people with Postmenopausal Symptoms, run by Hilal Yeşil 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 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: finished, as of the sponsor's last update on 12 Feb 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 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?
Change from baseline Falls Risk for Older People-Community Setting (FROP-COM) score at 4 th week. (time frame: up to 4 weeks). 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 12 Feb 2020.