The Effect of Exercise Intervention on the Community's Older Adults

The Effect of Exercise Intervention on the Physical Fitness, Bone Mineral Density and Health-related Quality of Life in the Community's Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Disease
• Intervention / Treatment: Other: exercise

• Study Type: Interventional
• Enrollment (Actual): 411
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Pizi, Taiwan, 613
    • Sports Medicine Center, Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; without exercise intervention
Experimental: Exercise; Subjects with circuit exercise, aerobic dance, or Tai Chi exercise intervention.	Other: exercise; circuit exercise, aerobic dance and Tai Chi exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Robert Wen-Wei HSU, MD, Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: CMRPG690111-3;CMRPG6A0421-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED