OsteoporosisNCT02608749
Osteoporosis and Fall Prevention High Risk Population Intervention and Follow up in the Metropolitan Area
A study testing Integrated care (IC), Lower extremity exercise (LEE) and Home care (HC) in people with Osteoporosis and Fracture, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
BACKGROUND: The deterioration of musculoskeletal system imposes significant impact on physical activity in older adults. METHODS: This was a randomized, parallel-group, prospective study. All participants received education program including home-based exercise. 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?
- Integrated care (IC), Lower extremity exercise (LEE) and Home care (HC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2014to Dec 2014
- 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 osteoporosis 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
- 1. If patients were unable to meet at least the above inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
BACKGROUND: The deterioration of musculoskeletal system imposes significant impact on physical activity in older adults.
METHODS: This was a randomized, parallel-group, prospective study. All participants received education program including home-based exercise. The IC group consisted of different modalities of exercise while the LEE group performed machine-based exercise. Body composition, muscle strength, and physical performance were measured at their baseline and 3 months follow-up.
- Conditions
- Osteoporosis, Fracture
- Being tested
- Integrated care (IC), Lower extremity exercise (LEE), Home care (HC)
- Keywords
- Osteoporosis, Fall, Fracture, Sacopenia, Body Composition
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated care (IC)Behavioural
Integraded care (IC) Weekly professional led exercise program for 90 mins with reinforcemen on osteoporosis related educations and caremangements 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.
Lower extremity exercise (LEE)Behavioural
Lower extremity exercise (LEE) group subjects were invited to BB site to receive 2 sessions of 45-mintute training using isotonic strength training machines on major muslce 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.
Home care (HC)Behavioural
Home care (HC) group subjects were invited to LK site. For examining whether the exercise video could help elderly people to maintain their exercise and improve their muscle strength or not, the investigators provided exercise video to subjects, and encouraged them to play this exercise at least 2 hours for one week.
| Study group | Role | What they receive |
|---|---|---|
| IC | Experimental | Integrated care (IC) Receives: Behavioral: Integrated care (IC) |
| LEE | Experimental | Lower extremity exercise (LEE) Receives: Behavioral: Lower extremity exercise (LEE) |
| HC | Experimental | Home care (HC) Receives: Behavioral: Home care (HC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity extensor power measured by isokinetic resistance equipment
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 posted20 Nov 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ding-Cheng Chan, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608749
- Sponsor's protocol ID
- 201402022RINB
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 23 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis and Fall Prevention High Risk Population Intervention and Follow up in the Metropolitan Area
- ClinicalTrials.gov ID
- NCT02608749
- Acronym / sponsor ID
- 201402022RINB
- Conditions
- Osteoporosis, Fracture
- Keywords
- Osteoporosis, Fall, Fracture, Sacopenia, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Nov 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.
BACKGROUND: The deterioration of musculoskeletal system imposes significant impact on physical activity in older adults.
METHODS: This was a randomized, parallel-group, prospective study. All participants received education program including home-based exercise. The IC group consisted of different modalities of exercise while the LEE group performed machine-based exercise. Body composition, muscle strength, and physical performance were measured at their baseline and 3 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IC | Experimental | Behavioral: Integrated care (IC)Integrated care (IC) |
| LEE | Experimental | Behavioral: Lower extremity exercise (LEE)Lower extremity exercise (LEE) |
| HC | Experimental | Behavioral: Home care (HC)Home care (HC) |
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 (1 listed)
- 1. If patients were unable to meet at least the above inclusion criteria.
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 |
|---|---|---|
| Integrated care (IC)Integraded care (IC) Weekly professional led exercise program for 90 mins with reinforcemen on osteoporosis related educations and caremangements 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. | Behavioural | IC |
| Lower extremity exercise (LEE)Lower extremity exercise (LEE) group subjects were invited to BB site to receive 2 sessions of 45-mintute training using isotonic strength training machines on major muslce 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 | LEE |
| Home care (HC)Home care (HC) group subjects were invited to LK site. For examining whether the exercise video could help elderly people to maintain their exercise and improve their muscle strength or not, the investigators provided exercise video to subjects, and encouraged them to play this exercise at least 2 hours for one week. | Behavioural | HC |
Primary outcome
Lower extremity extensor power measured by isokinetic resistance equipment
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 23 Nov 2015.
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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 Integrated care (IC), Lower extremity exercise (LEE) and Home care (HC) in people with Osteoporosis and 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 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 23 Nov 2015. 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 measured by isokinetic resistance equipment (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 23 Nov 2015.