Osteoporosis FractureNCT02483286
Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area
A study testing ICG, MTG and XBG in people with Osteoporosis Fracture, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
OBJECTIVES To determine the effects of 3 exercise interventions on sarcopenic indices among community-dwelling older adults with high osteoporotic fracture risks. MATERIAL AND METHOD The current study enrolled subjects who screened high risk of fall, osteoporosis/fracture by standardized questionnaires or FRAX. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis Fracture
- What is being tested?
- ICG, MTG and XBG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 May 2015to 15 Apr 2017
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 50 years of age
- high risk as defined from one of the following criteria:
- score>=1 on one minute osteoporosis risk questionnaire
- 10 year predicted fracture risk >=20% for major osteoporotic fracture or >=3% for hip fracture from FRAX
- fall>=2 times in pass 1 year
- having a bone mineral density test within one year period
- having the capability to understand the study and complete the study interventions
- willing to participate for the intervention and study follow ups
Who cannot join
- People younger than 50 years of age
- Could not communicate because of hearing, visual, or cognitive problems
- Unable to stand and walk unaided (walking aids are acceptable)
Trial locations and contacts
1 site in 1 country.
About this study
OBJECTIVES To determine the effects of 3 exercise interventions on sarcopenic indices among community-dwelling older adults with high osteoporotic fracture risks.
MATERIAL AND METHOD The current study enrolled subjects who screened high risk of fall, osteoporosis/fracture by standardized questionnaires or FRAX. Subjects at the National Taiwan University Hospital Bei-Hu Branch (NTUHBB) were randomized into integrated care group (ICG, target n=50) and muscle training group (MTG, target n=50). Subjects from Lingko Chang Gung Memorial Hospital (LCGMH) were all assigned into X-box group (XBG, target n=30). All participants received a CD-ROM and a one education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, and coping strategy and another hour of professional led exercise program. ICG subjects received once weekly group exercise while MTG subjects received twice weekly machine-based resistence training on major muscle groups. XBG subjects rececived twice weekly exercise with X-box based programs. Major outcomes were muscle mass (measured by bio-impedance analysis), grip strength, walking speed, and lower leg extension power at baseline and after 12-weeks of intervention.
- Conditions
- Osteoporosis Fracture
- Being tested
- ICG, MTG, XBG
- Keywords
- Osteoporosis, Fall, Fracture, sarcopenia, Exercise
- Medical subject headings
- Osteoporotic Fractures, Osteoporosis, Fractures, Bone, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICGBehavioural
Core 2-hour education course including practice of study home exercise program. Weekly professional led exercise program for 90 mins at NTUHBB site with reinforcement on osteoporosis related educations and care managements from study educational booklet and CD-rom for 3-month.
The exercise program included 15 minutes warm up with 10 minute brisk walks followed by gentle stretching. Resistance training (20-30 minutes) was provided with rubber band and bottled water (0.6-1L) as weight for major muscles of upper and lower limbs. Balance training were also provided for 10 minutes with tandem gaits and one leg standing, step up and down stairs, toe walking and heel walking.
Subjects are encouraged to practice study home exercise program at least twice weekly.
MTGBehavioural
MTG group subjects were invited to NTUHBB site to receive 2 sessions of 45-minute training using isotonic strength training machines on major muscle groups each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments by trained physical therapist
XBGBehavioural
XBG group subjects were invited to LCGMH site to receive 2 sessions of 45-minute training using x-box machine with combination programs selected from existing commercial programs with a exercise training specialist.
| Study group | Role | What they receive |
|---|---|---|
| ICG | Experimental | Integrated Care Group Receives: Behavioral: ICG |
| MTG | Experimental | Muscle Training Group Receives: Behavioral: MTG |
| XBG | Experimental | X-box Group Receives: Behavioral: XBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity extensor power
Lower extremity extensor power is measured by isokinetic resistance equipment by a trained research assistant with standardized protocol
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start29 May 2015
- Primary completion5 Oct 2016
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis FractureStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Taiwanese Osteoporosis Association., Wang Jhan-Yang Charitable Trust Fund
- Responsible party
- Sponsor
- Investigators
- Ding-Cheng Chan, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483286
- Sponsor's protocol ID
- 201503038RINB
- Status last verified
- Jan 2016
- First submitted
- 24 Jun 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area
- ClinicalTrials.gov ID
- NCT02483286
- Acronym / sponsor ID
- 201503038RINB
- Conditions
- Osteoporosis Fracture
- Keywords
- Osteoporosis, Fall, Fracture, sarcopenia, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- The Taiwanese Osteoporosis Association., Wang Jhan-Yang Charitable Trust Fund
- Study start
- 29 May 2015 (actual)
- Primary completion
- 5 Oct 2016 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 26 Jun 2015 (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.
OBJECTIVES To determine the effects of 3 exercise interventions on sarcopenic indices among community-dwelling older adults with high osteoporotic fracture risks.
MATERIAL AND METHOD The current study enrolled subjects who screened high risk of fall, osteoporosis/fracture by standardized questionnaires or FRAX. Subjects at the National Taiwan University Hospital Bei-Hu Branch (NTUHBB) were randomized into integrated care group (ICG, target n=50) and muscle training group (MTG, target n=50). Subjects from Lingko Chang Gung Memorial Hospital (LCGMH) were all assigned into X-box group (XBG, target n=30). All participants received a CD-ROM and a one education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, and coping strategy and another hour of professional led exercise program. ICG subjects received once weekly group exercise while MTG subjects received twice weekly machine-based resistence training on major muscle groups. XBG subjects rececived twice weekly exercise with X-box based programs. Major outcomes were muscle mass (measured by bio-impedance analysis), grip strength, walking speed, and lower leg extension power at baseline and after 12-weeks of intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICG | Experimental | Behavioral: ICGIntegrated Care Group |
| MTG | Experimental | Behavioral: MTGMuscle Training Group |
| XBG | Experimental | Behavioral: XBGX-box Group |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- older than 50 years of age
- high risk as defined from one of the following criteria:
- having a bone mineral density test within one year period
- having the capability to understand the study and complete the study interventions
- willing to participate for the intervention and study follow ups
Key exclusion criteria (3 listed)
- People younger than 50 years of age
- Could not communicate because of hearing, visual, or cognitive problems
- Unable to stand and walk unaided (walking aids are acceptable)
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 |
|---|---|---|
| ICGCore 2-hour education course including practice of study home exercise program. Weekly professional led exercise program for 90 mins at NTUHBB site with reinforcement on osteoporosis related educations and care managements from study educational booklet and CD-rom for 3-month. The exercise program included 15 minutes warm up with 10 minute brisk walks followed by gentle stretching. Resistance training (20-30 minutes) was provided with rubber band and bottled water (0.6-1L) as weight for major muscles of upper and lower limbs. Balance training were also provided for 10 minutes with tandem gaits and one leg standing, step up and down stairs, toe walking and heel walking. Subjects are encouraged to practice study home exercise program at least twice weekly. | Behavioural | ICG |
| MTGMTG group subjects were invited to NTUHBB site to receive 2 sessions of 45-minute training using isotonic strength training machines on major muscle groups each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments by trained physical therapist | Behavioural | MTG |
| XBGXBG group subjects were invited to LCGMH site to receive 2 sessions of 45-minute training using x-box machine with combination programs selected from existing commercial programs with a exercise training specialist. | Behavioural | XBG |
Primary outcome
Lower extremity extensor power
Time frame: 12 weeks
Lower extremity extensor power is measured by isokinetic resistance equipment by a trained research assistant with standardized protocol
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 22 Aug 2017.
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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.
Ding-Cheng Chan principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG, MTG and XBG in people with Osteoporosis Fracture, run by National Taiwan University 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 8 inclusion and 3 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 22 Aug 2017. 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?
Lower extremity extensor power (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2017.