Osteoporosis RiskNCT06081764
Investigation of the Effects of Physical Activity in Women at Risk of Osteoporosis
A study testing Exercise in people with Osteoporosis Risk, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate the effects of the increase in the physical activity level of women at risk for osteoporosis in the post-menopausal period on the physical fitness, functional fitness age and quality of life. Read more about this study
- Who is it for?
- Ages 54 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis Risk
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2022to 15 Feb 2023
- 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 54 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being at medium-high risk as a result of the Osteoporosis Self-Assessment Tool for Women (OST)
- Being 54 years old and over
- Being in the post-menopausal period
Who cannot join
- Having a broken history
- Having a history of surgery in the last 1 year
- Having a cognitive or physical condition that will prevent them from exercising
- Exercising regularly for more than 30 minutes a day, at least 3 days a week
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University
Gölhisar, Burdur, 15400
About this study
Official title: Investigation of the Effects of Physical Activity on Physical Fitness Parameters, Functional Fitness Age and Quality of Life in Women at Risk of Osteoporosis
The goal of this clinical trial is to investigate the effects of the increase in the physical activity level of women at risk for osteoporosis in the post-menopausal period on the physical fitness, functional fitness age and quality of life. The main question it aims to answer is:
- Does the increase in the level of physical activity positively affect the physical fitness parameters (strength, endurance, balance, agility and flexibility), functional fitness ages and quality of life of post-menopausal women with moderate to high osteoporosis risk?
Read more
Participants in the intervention group were given the Otago Exercise Program, which will last 3 days a week and an average of 30 minutes per day for 12 weeks. The exercises were done one-by-one with a physiotherapist. No program were applied to the participants in the control group, and they were asked to continue their daily living activities in the same way.
Researchers will compare two groups to see if there is a difference in effects of Otogo Exercise Program on physical fitness, functional fitness age, and quality of life.
Read the detailed description
The osteoporosis risks of the participants were calculated according to the Osteoporosis Self-Assessment Tool for Women (OST). Women have medium and high risk were included in the study.
Otago Exercise Program includes strengthening exercises consisting of knee extension, knee flexion, hip abduction, ankle dorsi flexion, and 12 balance exercises consisting of plantar flexion and squatting, walking backward, walking and rolling back, sideways walking, tandem stance, tandem gait, standing on one leg, heels walking on toes, walking on tiptoe, sitting and standing, climbing and descending stairs, and backward tandem walking.
- In addition, moderate-intensity walking exercise for 30 minutes a day, 2 days a week, was recommended to the patients in experimental group.
- Conditions
- Osteoporosis Risk
- Being tested
- Exercise
- Keywords
- Functional Fitness Age, Osteoporosis, Otago Exercise Program, Post-Menopausal Woman, Quality of Life, Physical Fitness
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Doing Otago Exercise Program, which lasting 3 days a week and an average of 30 minutes per day under the supervision of a physiotherapist. Also doing walking exercise for 30 minutes a day, 2 days a week for total of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Otago Exercise Program | Experimental | They participated the Otago Exercise Program, which last 3 days a week and an average of 30 minutes per day for 12 weeks in total. In addition, they did moderate-intensity walking exercise for 30 minutes a day, 2 days a week. Receives: Other: Exercise |
| Control Group | No intervention | No program were applied to the participants in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Strength
Lower extremity strength will be evaluated with the 30-second sit-stand test included in the ''Senior Fitness Test'', which is a physical fitness assessment tool.
Measured: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Upper Extremity Strength
Upper extremity strength will be evaluated with the 30-second elbow bend test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool.
Measured: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Aerobic Endurance
Aerobic endurance will be evaluated with the 2-minute walking test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool.
Measured: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Upper Extremity Flexibility
Upper extremity flexibility will be evaluated with the sit-reach test and back scratching test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool.
Measured: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Agility
Agility will be evaluated with the stand-up and walk test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool.
Measured: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Quality of Life of Individual
Quality of Life was tested with the ''Quality of Life for Osteoporosis Questionnaire''. The scale consists of 41 questions. There are 5 subscales: pain (5 items), physical function (17 items), social activity (7 items), general health assessment (3 items) and mental function (9 items). For each subgroup and total result in the scale, 0 points indicate the best health status, while higher scores indicate poor quality of life.
Measured: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Secondary outcomes (1)
Dynamic Balance
In addition to evaluating agility with the standing and walking test included in the "Senior Fitness Test", which is a physical condition evaluation tool, dynamic balance will also be evaluated since this test is an indicator of dynamic balance.
Measured: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start15 Jan 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis RiskStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Nur Alçın, Pamukkale University
- Investigators
- Nilüfer Çetişli Korkmaz, Prof., Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081764
- Sponsor's protocol ID
- 03.12.2021-E.136626
- Status last verified
- Oct 2023
- First submitted
- 25 Aug 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wen HJ, Huang TH, Li TL, Chong PN, Ang BS. Effects of short-term step aerobics exercise on bone metabolism and functional fitness in postmenopausal women with low bone mass. Osteoporos Int. 2017 Feb;28(2):539-547. doi: 10.1007/s00198-016-3759-4. Epub 2016 Sep 9.
PubMed 27613719Latorre-Rojas EJ, Prat-Subirana JA, Peirau-Teres X, Mas-Alos S, Beltran-Garrido JV, Planas-Anzano A. Determination of functional fitness age in women aged 50 and older. J Sport Health Sci. 2019 May;8(3):267-272. doi: 10.1016/j.jshs.2017.01.010. Epub 2017 Jan 23.
PubMed 31193284Subramaniam S, Ima-Nirwana S, Chin KY. Performance of Osteoporosis Self-Assessment Tool (OST) in Predicting Osteoporosis-A Review. Int J Environ Res Public Health. 2018 Jul 9;15(7):1445. doi: 10.3390/ijerph15071445.
PubMed 29987247Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4.
PubMed 20817938Yang Y, Wang K, Liu H, Qu J, Wang Y, Chen P, Zhang T, Luo J. The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. Front Public Health. 2022 Oct 20;10:953593. doi: 10.3389/fpubh.2022.953593. eCollection 2022.
PubMed 36339194
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Physical Activity on Physical Fitness Parameters, Functional Fitness Age and Quality of Life in Women at Risk of Osteoporosis
- ClinicalTrials.gov ID
- NCT06081764
- Acronym / sponsor ID
- 03.12.2021-E.136626
- Conditions
- Osteoporosis Risk
- Keywords
- Functional Fitness Age, Osteoporosis, Otago Exercise Program, Post-Menopausal Woman, Quality of Life, Physical Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 13 Oct 2023 (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.
The goal of this clinical trial is to investigate the effects of the increase in the physical activity level of women at risk for osteoporosis in the post-menopausal period on the physical fitness, functional fitness age and quality of life. The main question it aims to answer is:
- Does the increase in the level of physical activity positively affect the physical fitness parameters (strength, endurance, balance, agility and flexibility), functional fitness ages and quality of life of post-menopausal women with moderate to high osteoporosis risk?
Participants in the intervention group were given the Otago Exercise Program, which will last 3 days a week and an average of 30 minutes per day for 12 weeks. The exercises were done one-by-one with a physiotherapist. No program were applied to the participants in the control group, and they were asked to continue their daily living activities in the same way.
Researchers will compare two groups to see if there is a difference in effects of Otogo Exercise Program on physical fitness, functional fitness age, and quality of life.
Detailed description
The osteoporosis risks of the participants were calculated according to the Osteoporosis Self-Assessment Tool for Women (OST). Women have medium and high risk were included in the study.
Otago Exercise Program includes strengthening exercises consisting of knee extension, knee flexion, hip abduction, ankle dorsi flexion, and 12 balance exercises consisting of plantar flexion and squatting, walking backward, walking and rolling back, sideways walking, tandem stance, tandem gait, standing on one leg, heels walking on toes, walking on tiptoe, sitting and standing, climbing and descending stairs, and backward tandem walking.
- In addition, moderate-intensity walking exercise for 30 minutes a day, 2 days a week, was recommended to the patients in experimental group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otago Exercise Program | Experimental | Other: ExerciseThey participated the Otago Exercise Program, which last 3 days a week and an average of 30 minutes per day for 12 weeks in total. In addition, they did moderate-intensity walking exercise for 30 minutes a day, 2 days a week. |
| Control Group | No intervention | –No program were applied to the participants in the control group. |
Who may qualify
- Ages
- 54 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being at medium-high risk as a result of the Osteoporosis Self-Assessment Tool for Women (OST)
- Being 54 years old and over
- Being in the post-menopausal period
Key exclusion criteria (4 listed)
- Having a broken history
- Having a history of surgery in the last 1 year
- Having a cognitive or physical condition that will prevent them from exercising
- Exercising regularly for more than 30 minutes a day, at least 3 days a week
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 |
|---|---|---|
| ExerciseDoing Otago Exercise Program, which lasting 3 days a week and an average of 30 minutes per day under the supervision of a physiotherapist. Also doing walking exercise for 30 minutes a day, 2 days a week for total of 12 weeks. | Other | Otago Exercise Program |
Primary outcome
Lower Extremity Strength
Time frame: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Lower extremity strength will be evaluated with the 30-second sit-stand test included in the ''Senior Fitness Test'', which is a physical fitness assessment tool.
Upper Extremity Strength
Time frame: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Upper extremity strength will be evaluated with the 30-second elbow bend test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool.
Aerobic Endurance
Time frame: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Aerobic endurance will be evaluated with the 2-minute walking test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool.
Upper Extremity Flexibility
Time frame: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Upper extremity flexibility will be evaluated with the sit-reach test and back scratching test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool.
Agility
Time frame: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Agility will be evaluated with the stand-up and walk test included in the ''Senior Fitness Test'', which is a physical fitness evaluation tool.
Quality of Life of Individual
Time frame: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
Quality of Life was tested with the ''Quality of Life for Osteoporosis Questionnaire''. The scale consists of 41 questions. There are 5 subscales: pain (5 items), physical function (17 items), social activity (7 items), general health assessment (3 items) and mental function (9 items). For each subgroup and total result in the scale, 0 points indicate the best health status, while higher scores indicate poor quality of life.
1 secondary outcome
Dynamic Balance
Time frame: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.
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 13 Oct 2023.
- Background: PubMed 27613719Wen HJ, Huang TH, Li TL, Chong PN, Ang BS. Effects of short-term step aerobics exercise on bone metabolism and functional fitness in postmenopausal women with low bone mass. Osteoporos Int. 2017 Feb;28(2):539-547. doi: 10.1007/s00198-016-3759-4. Epub 2016 Sep 9.
- Background: PubMed 31193284Latorre-Rojas EJ, Prat-Subirana JA, Peirau-Teres X, Mas-Alos S, Beltran-Garrido JV, Planas-Anzano A. Determination of functional fitness age in women aged 50 and older. J Sport Health Sci. 2019 May;8(3):267-272. doi: 10.1016/j.jshs.2017.01.010. Epub 2017 Jan 23.
- Background: PubMed 29987247Subramaniam S, Ima-Nirwana S, Chin KY. Performance of Osteoporosis Self-Assessment Tool (OST) in Predicting Osteoporosis-A Review. Int J Environ Res Public Health. 2018 Jul 9;15(7):1445. doi: 10.3390/ijerph15071445.
- Background: PubMed 20817938Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4.
- Background: PubMed 36339194Yang Y, Wang K, Liu H, Qu J, Wang Y, Chen P, Zhang T, Luo J. The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. Front Public Health. 2022 Oct 20;10:953593. doi: 10.3389/fpubh.2022.953593. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Nilüfer Çetişli Korkmaz, Prof. study director
Pamukkale 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 Osteoporosis Risk, run by Pamukkale University 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 3 inclusion and 4 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 13 Oct 2023. 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?
Lower Extremity Strength (time frame: The first measurement was made just before the start of the treatment, and the second measurement was made just after the end of the treatment.). The study lists 6 primary outcomes in all. 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 NCT06081764, which also lists 5 linked publications.
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 13 Oct 2023.