Clinical trial NCT02936336: The Effect of Exercise Intervention on the Community's Older Adults
Official title: The Effect of Exercise Intervention on the Physical Fitness, Bone Mineral Density and Health-related Quality of Life in the Community's Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disease
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 411
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline bone mineral density
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary outcomes:
measure: Change from baseline elbow muscle strength
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
measure: Change from baseline shoulder muscle strength
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
measure: Change from baseline hip muscle strength
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
measure: Change from baseline knee muscle strength
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
measure: Change from baseline SF-36 questionnaire assessment
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
measure: High-density lipoprotein from blood sample
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
measure: Triglyceride from blood sample
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
measure: Fasting blood glucose from blood sample
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
measure: Blood pressure
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
measure: Weight parameters of the subjects
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
measure: Height parameters of the subjects
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
measure: Waistline parameters of the subjects
timeFrame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Other outcomes:
Locations:
city: Pizi
country: Taiwan
facility: Sports Medicine Center, Chang Gung Memorial Hospital
Study officials:
affiliation: Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
name: Robert Wen-Wei HSU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu WH, Hsu WB, Fan CH, Hsu RW. Predicting osteoporosis with body compositions in postmenopausal women: a non-invasive method. J Orthop Surg Res. 2021 Mar 24;16(1):215. doi: 10.1186/s13018-021-02351-3.