Fallers Aged 60 Years and OlderNCT01039779
Tai Chi Exercise in Older People
A study testing Exercise in people with Fallers Aged 60 Years and Older, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The effects of tai chi exercise and lower-extremity training on improving the primary outcome and secondary outcomes among older people will be compared. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fallers Aged 60 Years and Older
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Jun 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons aged 60 years and older and who require medical attention in the emergency rooms due to sustaining a fall.
Who cannot join
- A major unstable cardiopulmonary disease
- Cognitive impairment
- Contraindications to physical exercise
- The inability to ambulate
- Frail elderly.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Tai Chi Exercise on Reducing Falls in Older Taiwanese People
The effects of tai chi exercise and lower-extremity training on improving the primary outcome and secondary outcomes among older people will be compared.
Read the detailed description
Does not desire.
- Conditions
- Fallers Aged 60 Years and Older
- Being tested
- Exercise
- Keywords
- older fallers, tai chi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise will be taught every week over the 6-month intervention period at a subject's residence by instructors.
| Study group | Role | What they receive |
|---|---|---|
| Lower-extremity exercise training | Active comparator | This training will be tailored by physical therapists for each participant. A series of exercises will be applied to increase the stability of the trunk muscles and to strengthen the leg muscles. Receives: Behavioral: Exercise |
| Tai chi exercise | Active comparator | Yang-style tai chi with 18 movements will be taught every week over the 6-month intervention period at a subject's residence by tai chi instructors Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
To ascertain the occurrence of falls
Measured: 18 months
Secondary outcomes (1)
Fall-related outcomes of physical and psychological functions will assessed using direct interviews or performance tests at the subject's residence
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startJan 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallers Aged 60 Years and OlderStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Principal investigator, Mau-Roung Lin, Taipei Medical University
- Investigators
- Mau-Roung Lin, Ph.D., Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039779
- Sponsor's protocol ID
- NHRI-EX102-9805PI
- Status last verified
- May 2015
- First submitted
- 24 Dec 2009
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Tai Chi Exercise on Reducing Falls in Older Taiwanese People
- ClinicalTrials.gov ID
- NCT01039779
- Acronym / sponsor ID
- NHRI-EX102-9805PI
- Conditions
- Fallers Aged 60 Years and Older
- Keywords
- older fallers, tai chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- Jan 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Dec 2009 (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.
The effects of tai chi exercise and lower-extremity training on improving the primary outcome and secondary outcomes among older people will be compared.
Detailed description
Does not desire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower-extremity exercise training | Active comparator | Behavioral: ExerciseThis training will be tailored by physical therapists for each participant. A series of exercises will be applied to increase the stability of the trunk muscles and to strengthen the leg muscles. |
| Tai chi exercise | Active comparator | Behavioral: ExerciseYang-style tai chi with 18 movements will be taught every week over the 6-month intervention period at a subject's residence by tai chi instructors |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons aged 60 years and older and who require medical attention in the emergency rooms due to sustaining a fall.
Key exclusion criteria (5 listed)
- A major unstable cardiopulmonary disease
- Cognitive impairment
- Contraindications to physical exercise
- The inability to ambulate
- Frail elderly.
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 |
|---|---|---|
| ExerciseExercise will be taught every week over the 6-month intervention period at a subject's residence by instructors. | Behavioural | Lower-extremity exercise training, Tai chi exercise |
Primary outcome
To ascertain the occurrence of falls
Time frame: 18 months
1 secondary outcome
Fall-related outcomes of physical and psychological functions will assessed using direct interviews or performance tests at the subject's residence
Time frame: 18 months
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 19 May 2015.
Related trials for Fallers Aged 60 Years and Older
Recruiting
Contribution of GFAP and UCH-L1 Assays in Whole Blood to Optimizing Personalized Care for "Repeated Fallers" Hospitalized in Geriatric Wards
Fallers Aged 60 Years and Older, Biomarkers / Blood
Not yet recruiting
Validation of the Self-Assessment for Falls in the Elderly (SAFE) Questionnaire to Assess the Risk of Falls in People Aged 60 or Over.
Fall Prevention, Falls (Accidents) in Old Age
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.
Mau-Roung Lin, Ph.D. principal investigator
Taipei Medical University
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 Fallers Aged 60 Years and Older, run by Taipei Medical University 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 1 inclusion and 5 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 19 May 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?
To ascertain the occurrence of falls (time frame: 18 months). 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 19 May 2015.