Frailty
Conditions
Brief 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. We hypothesize that long-term Tai Chi training will improve specific nonlinear properties associated of cardiovascular and balance dynamics in this population.
Interventions
OTHERTai Chi
The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
OTHEREducation-Control
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)
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Hebrew SeniorLife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frailty Index | post-intervention | Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tai Chi Group Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week). | 35 |
| Educational Control Group Education-Control: 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) | 31 |
| Total | 66 |
Baseline characteristics
| Characteristic | Tai Chi Group | Educational Control Group | Total |
|---|---|---|---|
| Age, Continuous | 87 years STANDARD_DEVIATION 5 | 86 years STANDARD_DEVIATION 6 | 87 years STANDARD_DEVIATION 6 |
| Frailty Index Frail | 10 participants | 6 participants | 16 participants |
| Frailty Index Nonfrail | 5 participants | 2 participants | 7 participants |
| Frailty Index Prefrail | 20 participants | 23 participants | 43 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 28 Participants | 24 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 31 |
| serious Total, serious adverse events | 0 / 35 | 0 / 31 |
Outcome results
Primary
Frailty Index
Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.
Time frame: post-intervention
Population: per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tai Chi Group | Frailty Index | Frail | 7 participants |
| Tai Chi Group | Frailty Index | Prefrail | 16 participants |
| Tai Chi Group | Frailty Index | Nonfrail | 6 participants |
| Educational Control Group | Frailty Index | Frail | 5 participants |
| Educational Control Group | Frailty Index | Prefrail | 21 participants |
| Educational Control Group | Frailty Index | Nonfrail | 2 participants |
p-value: 0.15Fisher Exact