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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06457308
Other study ID # TainanHMHW
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 14, 2021
Est. completion date December 31, 2022

Study information

Verified date April 2024
Source Tainan Hospital, Ministry of Health and Welfare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date December 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years and older
Eligibility Inclusion Criteria: postmenopausal osteoporosis diagnosed with DXA( Hologic, W type, Caucasian reference, T-score?-2.5 in L-spine or hip) Exclusion Criteria: Unable to attend the training sessions due to physical problems Had joined previous exercise program

Study Design


Intervention

Biological:
Physical training of agility
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 resistance
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

Locations

Country Name City State
Taiwan Chen, Ying-Chen Tainan

Sponsors (1)

Lead Sponsor Collaborator
Tainan Hospital, Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. — View Citation

Lichtenstein 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. — View Citation

Miko 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. — View Citation

Morat 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Physical function of upper limb strength arm curl in 30 secs after the completed training course, about 12 weeks
Primary Physical function of upper limbs strength Hand grip after the completed training course, about 12 weeks
Primary Physical function of lower limbs Walking speed after the completed training course, about 12 weeks
Primary Physical function of dynamic balance Up and go test after the completed training course, about 12 weeks
Primary Physical function of lower limbs Sit to stand in 30 secs after the completed training course, about 12 weeks
Primary Physical function of static balance One leg stand test after the completed training course, about 12 weeks
Primary Stability index Biodex balance system device after the completed training course, about 12 weeks
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