FrailtyNCT01126723
Effects of Tai Chi on Frailty in Elderly Adults
A study testing Tai Chi in people with Frailty, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
The aim of this study is determine the effects of Tai Chi exercise, as compared to an education-based control intervention, on cardiovascular and balance system function in older people at risk of developing frailty. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Tai Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women over age 70 will be included if they are able to stand and walk unassisted, are free of any acute or unstable medical conditions, and are able to understand directions and participate in the protocol.
Who cannot join
- Potential subjects will be excluded 1) if they cannot stand and ambulate unassisted, 2) are experiencing any symptomatic cardiovascular or respiratory disease, or have 3) a myocardial infarction or stroke within 6 months, 4) painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility, 5) systolic BP above 160 or diastolic BP above 100 mm Hg, 6) a cardiac pacemaker, 7) Parkinson's Disease or other neuromuscular disorder, 8) metastatic cancer or immunosuppressive therapy, or 9) have significant visual impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131
About this study
Official title: The Effects of Tai Chi on the Nonlinear Dynamics of Frailty in Elderly Adults
The aim of this study is determine the effects of Tai Chi exercise, as compared to an education-based control intervention, on cardiovascular and balance system function in older people at risk of developing frailty. We hypothesize that long-term Tai Chi training will improve specific nonlinear properties associated of cardiovascular and balance dynamics in this population.
- Conditions
- Frailty
- Being tested
- Tai Chi, Education-Control
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiOther
The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
Education-ControlOther
The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi group | Experimental | Not described Receives: Other: Tai Chi |
| Educational Control group | Active comparator | Not described Receives: Other: Education-Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty Index
Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.
Measured: post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FrailtyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Lewis Lipsitz, MD, Principal investigator, Hebrew Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126723
- Sponsor's protocol ID
- 10-005
- Other IDs
- R37AG025037
- Status last verified
- Dec 2023
- First submitted
- 18 May 2010
- Last updated
- 19 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tai Chi on the Nonlinear Dynamics of Frailty in Elderly Adults
- ClinicalTrials.gov ID
- NCT01126723
- Acronym / sponsor ID
- 10-005
- Conditions
- Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Posted 30 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is determine the effects of Tai Chi exercise, as compared to an education-based control intervention, on cardiovascular and balance system function in older people at risk of developing frailty. We hypothesize that long-term Tai Chi training will improve specific nonlinear properties associated of cardiovascular and balance dynamics in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi group | Experimental | Other: Tai Chi |
| Educational Control group | Active comparator | Other: Education-Control |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Men and women over age 70 will be included if they are able to stand and walk unassisted, are free of any acute or unstable medical conditions, and are able to understand directions and participate in the protocol.
Key exclusion criteria (1 listed)
- Potential subjects will be excluded 1) if they cannot stand and ambulate unassisted, 2) are experiencing any symptomatic cardiovascular or respiratory disease, or have 3) a myocardial infarction or stroke within 6 months, 4) painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility, 5) systolic BP above 160 or diastolic BP above 100 mm Hg, 6) a cardiac pacemaker, 7) Parkinson's Disease or other neuromuscular disorder, 8) metastatic cancer or immunosuppressive therapy, or 9) have significant visual impairment.
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 |
|---|---|---|
| Tai ChiThe Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week). | Other | Tai Chi group |
| Education-ControlThe Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week) | Other | Educational Control group |
Primary outcome
Frailty Index
Time frame: post-intervention
Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lewis Lipsitz, MD principal investigator
Hebrew Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi in people with Frailty, run by Hebrew SeniorLife at 1 site in United States.
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 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 19 Dec 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frailty Index (time frame: post-intervention). 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 Dec 2023.