Clinical trial NCT02346136: Health Outcomes of Tai Chi in Subsidized Senior Housing
Official title: Health Outcomes of Tai Chi in Subsidized Senior Housing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aging
Keywords: Tai Chi
Cluster randomized controlled trial
Intervention
Elderly
Mobility
Health care utilization
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Brandeis University
name: Massachusetts General Hospital
name: University of Massachusetts, Boston
First posted: 2015-01-26
Enrollment: 180
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed study will determine whether Tai Chi is an effective and practical intervention to improve overall function and lower health care utilization in an expensive, vulnerable population of seniors that is more representative of many US communities than those previously studied. If the results are favorable, our study will also provide the necessary training and protocol manuals to replicate Tai Chi programs in senior housing facilities across the nation to help prevent, better manage, and overcome frailty among seniors.

Detailed description: Elderly people living in low-income housing facilities represent one of our nation's largest, most functionally impaired, economically disadvantaged, and understudied populations that account for a disproportionate share of Medicare spending. This trial aims to test whether Tai Chi exercises improve the health and reduce the health care utilization of this population more than health education and social calls by conducting a cluster randomized controlled trial in 16 housing facilities in cities surrounding Boston. The proposal builds upon previously successful studies by Drs. Lipsitz, Wayne, and others showing multiple benefits of Tai Chi exercises in elderly people with a variety of diseases and disabilities. A randomized, controlled pilot study showed that 12 weeks of Tai Chi exercises tailored to the abilities of frail seniors living in supportive housing facilities can improve balance, gait, and physical function. The proposed study aims are to determine the effects of Tai Chi exercises conducted at least twice weekly over a 6-month period on 1) functional performance measured by the Short Physical Performance Battery and 2) health care utilization determined from self-reported emergency room visits and hospitalizations in poor, multiethnic, elderly residents of low income housing facilities. Secondary outcomes will include person-centered measures such as physical function, cognition, psychological well-being, falls, and self-efficacy. We hypothesize that compared to the control intervention, Tai Chi will significantly improve physical function and reduce health care utilization. This study will prepare the necessary training and protocol manuals for widespread dissemination of Tai Chi programs in housing facilities across the nation. It will also provide estimates of potential Medicare cost savings that can be used to justify future health insurance payments for this intervention.

Eligibility criteria: Inclusion Criteria:

* able to understand instructions in English
* able to participate safely in Tai Chi exercises at least twice a week
* expected to remain in the facility for 1 year
* are fee-for-service Medicare Beneficiaries for the 3 study years
* Able to stand/walk independently, without the help of another person

Exclusion Criteria:

* enrolled in a Program of All-Inclusive Care for the Elderly (PACE), or a Special Needs Plan, since this would make it difficult to isolate the effects of Tai Chi on health care utilization.
* Practice of Tai Chi for \>3 years over lifetime, or more than weekly in prior 6 months
* any unstable or terminal illness (e.g., unstable cardiovascular disease, active cancer, unstable chronic obstructive pulmonary disease (COPD), advanced dementia, psychosis)
* inability to maintain posture sitting or standing
* inability to hear, see, or understand Tai Chi instructions and assessment questions.

Primary outcomes:
measure: Change in Short Physical Performance Battery (SPPB) Total Score
timeFrame: Change from baseline to 6 months
measure: Health Care Utilization
timeFrame: up to 12 months
Secondary outcomes:
measure: Mobility
timeFrame: Change from baseline to 6 months
measure: Gait Velocity
timeFrame: Change from baseline to 6 months
measure: Standing Balance
timeFrame: Change from baseline to 6 months
measure: Grip Strength
timeFrame: Change from baseline to 6 months
measure: Self-reported Physical Activity
timeFrame: Change from baseline to 6 months
measure: Executive Function
timeFrame: Change from baseline to 6 months
measure: Health-related Quality-of-life
timeFrame: Change from baseline to 6 months
measure: Depression
timeFrame: Change from baseline to 6 months
measure: Exercise Self-efficacy
timeFrame: Change from baseline to 6 months
measure: Falls
timeFrame: 12 months
measure: Health Care Utilization
timeFrame: Baseline, 6 months and 12 months
measure: Mini-Mental State Examination
timeFrame: Change from baseline to 12 months
Other outcomes:
Locations:
city: Roslindale
country: United States
facility: Hebrew Rehabilitation Center
state: Massachusetts
Study officials:
affiliation: Director, Marcus Institute for Aging Research, Hebrew SeniorLife
name: Lewis Lipsitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Director, Osher Center, Brigham and Women's Hospital
name: Peter Wayne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wayne PM, Gagnon MM, Macklin EA, Travison TG, Manor B, Lachman M, Thomas CP, Lipsitz LA. The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study: Design and rationale of a cluster randomized controlled trial of Tai Chi in senior housing. Contemp Clin Trials. 2017 Sep;60:96-104. doi: 10.1016/j.cct.2017.07.005. Epub 2017 Jul 8.
citation: Lipsitz LA, Macklin EA, Travison TG, Manor B, Gagnon P, Tsai T, Aizpurua II, Lo OY, Wayne PM. A Cluster Randomized Trial of Tai Chi vs Health Education in Subsidized Housing: The MI-WiSH Study. J Am Geriatr Soc. 2019 Sep;67(9):1812-1819. doi: 10.1111/jgs.15986. Epub 2019 May 22.