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

Primary Purpose

Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Disease

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sports Medicine Center, Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Exercise

Arm Description

without exercise intervention

Subjects with circuit exercise, aerobic dance, or Tai Chi exercise intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
High-density lipoprotein from blood sample
High-density lipoprotein are measured at 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.
Fasting blood glucose from blood sample
Fasting blood glucose are measured at 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.
Weight parameters of the subjects
Weight (kg) are measured at 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.
Waistline parameters of the subjects
Waistline (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.

Full Information

First Posted
October 13, 2016
Last Updated
May 11, 2018
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02936336
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
411 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
without exercise intervention
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Subjects with circuit exercise, aerobic dance, or Tai Chi exercise intervention.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
circuit exercise, aerobic dance and Tai Chi exercise
Primary Outcome Measure Information:
Title
Change from baseline bone mineral density
Description
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.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary Outcome Measure Information:
Title
Change from baseline elbow muscle strength
Description
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.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Title
Change from baseline shoulder muscle strength
Description
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.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Title
Change from baseline hip muscle strength
Description
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.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Title
Change from baseline knee muscle strength
Description
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.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Title
Change from baseline SF-36 questionnaire assessment
Description
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.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Title
High-density lipoprotein from blood sample
Description
High-density lipoprotein are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Title
Triglyceride from blood sample
Description
Triglyceride are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Title
Fasting blood glucose from blood sample
Description
Fasting blood glucose are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Title
Blood pressure
Description
Diastolic and systolic blood pressure are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Title
Weight parameters of the subjects
Description
Weight (kg) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Title
Height parameters of the subjects
Description
Height (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Title
Waistline parameters of the subjects
Description
Waistline (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Time Frame
Pre-intervention, 3-month, 6-month, 9-month-follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wen-Wei HSU, MD
Organizational Affiliation
Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sports Medicine Center, Chang Gung Memorial Hospital
City
Pizi
ZIP/Postal Code
613
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33761975
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.
Results Reference
derived

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

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