Postmenopausal OsteoporosisNCT06457308
Compare the Agility Exercise and Resistance Exercise on Physical Function and Stability in Osteoporotic Women
A study testing Physical training of agility and Physical training of resistance in people with Postmenopausal Osteoporosis and Agility Exercise, run by Tainan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
Osteoporosis weakens bones with age, increasing fracture risk. Exercise improves physical function and reduces falls, crucial for preventing osteoporotic fractures, especially with balance, resistance, and multi-component training. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis, Agility Exercise, Physical Function
- What is being tested?
- Physical training of agility and Physical training of resistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jul 2021to 31 Dec 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women with osteoporosis( diagnosed with DXA, T-score≦-2.5 in L-spine or hip)
- postmenopausal, more than 50 years old,
Who cannot join
- unable to attend the training sessions due to physical problems
- had joined previous exercise program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tainan Hospital, Ministry of Health and Welfare, Taiwan
Osteoporosis weakens bones with age, increasing fracture risk. Exercise improves physical function and reduces falls, crucial for preventing osteoporotic fractures, especially with balance, resistance, and multi-component training. Agility exercise, integrating various aspects like aerobic, strength, balance, and cognitive tasks, is promising for fall prevention in older adults, though its effectiveness in osteoporosis is not extensively studied.
This study compares agility and resistance exercise impacts on physical function and balance stability in postmenopausal osteoporosis. Fifty-one women (average age: 68±6.3y, BMI: 22.3±2.7 kg/m2) were divided into agility exercise (AG), resistance exercise (RG), and control groups (CG) through purposive sampling. AG and RG received added intervention training once a week for 2 hours over 12 weeks. Main outcomes included physical function and balance stability measured through various tests.
Read the detailed description
Main activities of agility training group (AG): Use rope ladders and cones to perform multiple tasks of direction changes, acceleration and deceleration of footsteps, hand and foot coordination and spatial orientation training.
Main activities of resistance training group (AG): Resistance training for upper and lower limb muscles and core muscles, including squats, use of elastic bands, and simple bars.
- Conditions
- Postmenopausal Osteoporosis, Agility Exercise, Physical Function, Balance Stability, Fall Prevention
- Being tested
- Physical training of agility, Physical training of resistance
- Keywords
- postmenopausal osteoporosis, agility exercise, physical function, multi-component exercise, fall prevention
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical training of agilityBiological
A grouped training for older adults in the community. The training classed lasted for 12 weeks, one session a week for 120 mins, and are under instructed by a trained experienced sport instructor. Use rope ladders and cones to perform multiple tasks of direction changes, acceleration and deceleration of footsteps, hand and foot coordination and spatial orientation training,
Physical training of resistanceBiological
A grouped training for older adults in the community. The training classed lasted for 12 weeks, one session a week for 120 mins, and are under instructed by a trained experienced sport instructor. Resistance training for upper and lower limb muscles and core muscles, including squats, use of elastic bands, and simple bars
| Study group | Role | What they receive |
|---|---|---|
| Agility exercise training. | Experimental | Participants attend training class focused on agility training. Rope ladders and cones are used to perform multiple tasks of direction changes, acceleration and deceleration of footsteps, hand and foot coordination and spatial orientation training. Receives: Biological: Physical training of agility |
| Resistance exercise training. | Active comparator | Participants attend training class focused on resistance training. Resistance training for upper and lower limb muscles and core muscles, including squats, use of elastic bands, and simple bars. Receives: Biological: Physical training of resistance |
| Control | No intervention | Participants only receive osteoporosis education usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function of upper limb strength
arm curl in 30 secs
Measured: after the completed training course, about 12 weeks
Physical function of upper limbs strength
Hand grip
Measured: after the completed training course, about 12 weeks
Physical function of lower limbs
Walking speed
Measured: after the completed training course, about 12 weeks
Physical function of dynamic balance
Up and go test
Measured: after the completed training course, about 12 weeks
Physical function of lower limbs
Sit to stand in 30 secs
Measured: after the completed training course, about 12 weeks
Physical function of static balance
One leg stand test
Measured: after the completed training course, about 12 weeks
Stability index
Biodex balance system device
Measured: after the completed training course, about 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start14 Jul 2021
- Primary completion31 May 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized, quasi-experimental design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tainan Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457308
- Sponsor's protocol ID
- TainanHMHW
- Status last verified
- Aug 2024
- First submitted
- 6 Apr 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donath L, van Dieen J, Faude O. Exercise-Based Fall Prevention in the Elderly: What About Agility? Sports Med. 2016 Feb;46(2):143-9. doi: 10.1007/s40279-015-0389-5.
PubMed 26395115Lichtenstein E, Morat M, Roth R, Donath L, Faude O. Agility-based exercise training compared to traditional strength and balance training in older adults: a pilot randomized trial. PeerJ. 2020 Apr 14;8:e8781. doi: 10.7717/peerj.8781. eCollection 2020.
PubMed 32328344Morat M, Morat T, Zijlstra W, Donath L. Effects of multimodal agility-like exercise training compared to inactive controls and alternative training on physical performance in older adults: a systematic review and meta-analysis. Eur Rev Aging Phys Act. 2021 Feb 25;18(1):4. doi: 10.1186/s11556-021-00256-y.
PubMed 33632117Miko I, Szerb I, Szerb A, Bender T, Poor G. Effect of a balance-training programme on postural balance, aerobic capacity and frequency of falls in women with osteoporosis: A randomized controlled trial. J Rehabil Med. 2018 Jun 15;50(6):542-547. doi: 10.2340/16501977-2349.
PubMed 29767227
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tainan Hospital, Ministry of Health and Welfare, Taiwan
- ClinicalTrials.gov ID
- NCT06457308
- Acronym / sponsor ID
- TainanHMHW
- Conditions
- Postmenopausal Osteoporosis, Agility Exercise, Physical Function, Balance Stability, Fall Prevention
- Keywords
- postmenopausal osteoporosis, agility exercise, physical function, multi-component exercise, fall prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Tainan Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Jun 2024 (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.
Osteoporosis weakens bones with age, increasing fracture risk. Exercise improves physical function and reduces falls, crucial for preventing osteoporotic fractures, especially with balance, resistance, and multi-component training. Agility exercise, integrating various aspects like aerobic, strength, balance, and cognitive tasks, is promising for fall prevention in older adults, though its effectiveness in osteoporosis is not extensively studied.
This study compares agility and resistance exercise impacts on physical function and balance stability in postmenopausal osteoporosis. Fifty-one women (average age: 68±6.3y, BMI: 22.3±2.7 kg/m2) were divided into agility exercise (AG), resistance exercise (RG), and control groups (CG) through purposive sampling. AG and RG received added intervention training once a week for 2 hours over 12 weeks. Main outcomes included physical function and balance stability measured through various tests.
Detailed description
Main activities of agility training group (AG): Use rope ladders and cones to perform multiple tasks of direction changes, acceleration and deceleration of footsteps, hand and foot coordination and spatial orientation training.
Main activities of resistance training group (AG): Resistance training for upper and lower limb muscles and core muscles, including squats, use of elastic bands, and simple bars.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Non-randomized, quasi-experimental design.
| Arm | Type | Receives |
|---|---|---|
| Agility exercise training. | Experimental | Biological: Physical training of agilityParticipants attend training class focused on agility training. Rope ladders and cones are used to perform multiple tasks of direction changes, acceleration and deceleration of footsteps, hand and foot coordination and spatial orientation training. |
| Resistance exercise training. | Active comparator | Biological: Physical training of resistanceParticipants attend training class focused on resistance training. Resistance training for upper and lower limb muscles and core muscles, including squats, use of elastic bands, and simple bars. |
| Control | No intervention | –Participants only receive osteoporosis education usual care. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women with osteoporosis( diagnosed with DXA, T-score≦-2.5 in L-spine or hip)
- postmenopausal, more than 50 years old,
Key exclusion criteria (2 listed)
- unable to attend the training sessions due to physical problems
- had joined previous exercise program
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 |
|---|---|---|
| Physical training of agilityA grouped training for older adults in the community. The training classed lasted for 12 weeks, one session a week for 120 mins, and are under instructed by a trained experienced sport instructor. Use rope ladders and cones to perform multiple tasks of direction changes, acceleration and deceleration of footsteps, hand and foot coordination and spatial orientation training, | Biological | Agility exercise training. |
| Physical training of resistanceA grouped training for older adults in the community. The training classed lasted for 12 weeks, one session a week for 120 mins, and are under instructed by a trained experienced sport instructor. Resistance training for upper and lower limb muscles and core muscles, including squats, use of elastic bands, and simple bars | Biological | Resistance exercise training. |
Primary outcome
Physical function of upper limb strength
Time frame: after the completed training course, about 12 weeks
arm curl in 30 secs
Physical function of upper limbs strength
Time frame: after the completed training course, about 12 weeks
Hand grip
Physical function of lower limbs
Time frame: after the completed training course, about 12 weeks
Walking speed
Physical function of dynamic balance
Time frame: after the completed training course, about 12 weeks
Up and go test
Physical function of lower limbs
Time frame: after the completed training course, about 12 weeks
Sit to stand in 30 secs
Physical function of static balance
Time frame: after the completed training course, about 12 weeks
One leg stand test
Stability index
Time frame: after the completed training course, about 12 weeks
Biodex balance system device
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 20 Aug 2024.
- Background: PubMed 26395115Donath L, van Dieen J, Faude O. Exercise-Based Fall Prevention in the Elderly: What About Agility? Sports Med. 2016 Feb;46(2):143-9. doi: 10.1007/s40279-015-0389-5.
- Background: PubMed 32328344Lichtenstein E, Morat M, Roth R, Donath L, Faude O. Agility-based exercise training compared to traditional strength and balance training in older adults: a pilot randomized trial. PeerJ. 2020 Apr 14;8:e8781. doi: 10.7717/peerj.8781. eCollection 2020.
- Background: PubMed 33632117Morat M, Morat T, Zijlstra W, Donath L. Effects of multimodal agility-like exercise training compared to inactive controls and alternative training on physical performance in older adults: a systematic review and meta-analysis. Eur Rev Aging Phys Act. 2021 Feb 25;18(1):4. doi: 10.1186/s11556-021-00256-y.
- Background: PubMed 29767227Miko I, Szerb I, Szerb A, Bender T, Poor G. Effect of a balance-training programme on postural balance, aerobic capacity and frequency of falls in women with osteoporosis: A randomized controlled trial. J Rehabil Med. 2018 Jun 15;50(6):542-547. doi: 10.2340/16501977-2349.
- 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.
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 Physical training of agility and Physical training of resistance in people with Postmenopausal Osteoporosis and Agility Exercise, run by Tainan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
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 2 inclusion and 2 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 20 Aug 2024. 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 Taiwan. 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?
Physical function of upper limb strength (time frame: after the completed training course, about 12 weeks). The study lists 7 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 NCT06457308, which also lists 4 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 20 Aug 2024.