Metabolic DiseaseNCT02936336
The Effect of Exercise Intervention on the Community's Older Adults
A study testing exercise in people with Metabolic Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2009to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being >45 years-of-age,
- Healthy and physically independent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Metabolic Disease
- Being tested
- exercise
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
circuit exercise, aerobic dance and Tai Chi exercise
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | without exercise intervention |
| Exercise | Experimental | Subjects with circuit exercise, aerobic dance, or Tai Chi exercise intervention. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startNov 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Wen-Wei Hsu, Chang Gung Memorial Hospital
- Investigators
- Robert Wen-Wei HSU, MD, Principal investigator, Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936336
- Sponsor's protocol ID
- CMRPG690111-3;CMRPG6A0421-22
- Status last verified
- May 2018
- First submitted
- 13 Oct 2016
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 33761975
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02936336
- Acronym / sponsor ID
- CMRPG690111-3;CMRPG6A0421-22
- Conditions
- Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –without exercise intervention |
| Exercise | Experimental | Other: exerciseSubjects with circuit exercise, aerobic dance, or Tai Chi exercise intervention. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being >45 years-of-age,
- Healthy and physically independent.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercisecircuit exercise, aerobic dance and Tai Chi exercise | Other | Exercise |
Primary outcome
Change from baseline bone mineral density
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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.
12 secondary outcomes
Change from baseline elbow muscle strength
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Change from baseline shoulder muscle strength
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Change from baseline hip muscle strength
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Change from baseline knee muscle strength
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Change from baseline SF-36 questionnaire assessment
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
High-density lipoprotein from blood sample
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Triglyceride from blood sample
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Fasting blood glucose from blood sample
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Blood pressure
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Weight parameters of the subjects
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Height parameters of the subjects
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Waistline parameters of the subjects
Time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Derived from this study: PubMed 33761975Hsu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wen-Wei HSU, MD principal investigator
Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Metabolic Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline bone mineral density (time frame: Pre-intervention, 3-month, 6-month, 9-month-follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02936336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.