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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02936336
Other study ID # CMRPG690111-3;CMRPG6A0421-22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2009
Est. completion date December 2013

Study information

Verified date May 2018
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Osteoporosis is a serious global health problem, second only to cardiovascular disease. Osteoporosis is the most common metabolic bone disease in the elderly population, characterized by loss of bone mineral density (BMD) and continuous destruction of bone microstructure, especially in postmenopausal women. It gives rise to bone fragility and fracture risk. Moreover, as people grow older, falls frequently occur with high severity, and nearly 35% to 45% of persons aged 65 or older fall at least once a year. Osteoporotic fractures increase mortality, morbidity, chronic pain, and the cost of social care and it decreases the quality of life. Here, investigators plan to perform different exercise interventions such as circuit exercise, aerobic dance and Tai Chi on the community's older adults to evaluate whether exercise intervention could improve the bone mineral density, physical fitness, muscle strength or quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 411
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 45 Years to 85 Years
Eligibility Inclusion Criteria:

- Being >45 years-of-age,

- Healthy and physically independent.

Exclusion Criteria:

- The exclusion criteria were individuals on hormone replacement therapy and those with cognitive impairment, progressive debilitating conditions, bone fractures, or any medical contraindications to administering the fitness assessment.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
exercise
circuit exercise, aerobic dance and Tai Chi exercise

Locations

Country Name City State
Taiwan Sports Medicine Center, Chang Gung Memorial Hospital Pizi

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline bone mineral density Bone mineral density measurement is measured by dual-energy x-ray absorptiometry (DXA). Measurements are made over the lumbar spine and over the upper part of the hip and the measurement is assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary Change from baseline elbow muscle strength Extension and flexion of elbow were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.The Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg). The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary Change from baseline shoulder muscle strength Extension and flexion of shoulder were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.The Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg). The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary Change from baseline hip muscle strength Extension and flexion of hip were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.The Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg). The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary Change from baseline knee muscle strength Extension and flexion of knee were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.The Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg). The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary Change from baseline SF-36 questionnaire assessment SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower score the more disability. The higher the score the less disability. Eight sections including physical function, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health. Additionally, the eight health domains can be used to provide a physical component summary and mental component summary score. The outcome measurement is assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary High-density lipoprotein from blood sample High-density lipoprotein are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary Triglyceride from blood sample Triglyceride are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary Fasting blood glucose from blood sample Fasting blood glucose are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary Blood pressure Diastolic and systolic blood pressure are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary Weight parameters of the subjects Weight (kg) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary Height parameters of the subjects Height (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary Waistline parameters of the subjects Waistline (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up. Pre-intervention, 3-month, 6-month, 9-month-follow-up
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