Health Outcomes of Tai Chi in Subsidized Senior Housing

Aging Clinical Trial

— Mi-WISH  

Official title:

Health Outcomes of Tai Chi in Subsidized Senior Housing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02346136
• Other study ID #: 2R01AG025037-09A1
• Status: Terminated
• Phase: N/A
• Start date: July 2015
• Est. completion date: January 26, 2018

Study information

• Verified date: April 2018
• Source: Hebrew Rehabilitation Center, Boston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 180
• Est. completion date: January 26, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Tai Chi training

• Educational Control

Locations

Country	Name	City	State
United States	Hebrew Rehabilitation Center	Roslindale	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Hebrew Rehabilitation Center, Boston	Brandeis University, Brigham and Women's Hospital, Massachusetts General Hospital, University of Massachusetts, Boston

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lipsitz LA, Macklin EA, Travison TG, Manor B, Gagnon P, Tsai T, Aizpurúa 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Short Physical Performance Battery (SPPB) Total Score	The Short Physical Performance Battery includes measures of standing balance (timing of tandem, semi-tandem, and side-by-side stands), 4-meter walking speed and the ability and time to rise from a chair 5 times. The minimum score = 0, the maximum score=12. A higher score means a better outcome.	Change from baseline to 6 months
Primary	Health Care Utilization	Health care utilization will be defined by counts of hospitalizations during the study period.	up to 12 months
Secondary	Mobility	Mobility will be assessed by the Timed Up-and-Go, which records the time needed to stand from a chair, walk three meters, turn, walk back to the chair and sit down.	Change from baseline to 6 months
Secondary	Gait Velocity	Gait velocity will be measured in meters/second (m/s) during two conditions: Normal walking (NW) and Dual task(DT) condition (counting backwards by 3's or 1's while walking)	Change from baseline to 6 months
Secondary	Standing Balance	Standing balance will be assessed by recording 95% ellipse sway area with eyes open in meters squared (m2)	Change from baseline to 6 months
Secondary	Grip Strength	Grip strength of the dominant hand will be assessed with a hand-grip dynamometer in kilograms (kg).	Change from baseline to 6 months
Secondary	Self-reported Physical Activity	Self-reported physical activity will be assessed with the Physical Activity Scale for the Elderly (PASE). The range for this scale is 0-400, with higher score representing higher activity score (better outcome).	Change from baseline to 6 months
Secondary	Executive Function	Executive function will be assessed with the Trail Making Test (TMT). Participants are timed while sequentially connecting a series of numbered circles (TMT part A), as well as connecting an alternating series of numbers and letters (e.g., A-1-B-2-C-3…) (TMT part B).; The outcome measure is the time difference in seconds between Part B and Part A.	Change from baseline to 6 months
Secondary	Health-related Quality-of-life	Health-related quality-of-life will be assessed with the Short Form-12 (SF-12), which is a 12 item short form survey, a shortened version of the Short Form-36 (SF-36) health survey that is widely-utilized to assess physical and mental health, as well as the outcomes of healthcare services. The total score ranges from 0-100, with a lower score representing a better outcome for *both* the "Physical component" and "Mental Component"	Change from baseline to 6 months
Secondary	Depression	Depressive symptoms will be assessed with the Center of Epidemiology Studies-Depression Scale Revised (CESD-R). The 20 item CESD-R test score range is between 0-60, with a lower score representing a better outcome.	Change from baseline to 6 months
Secondary	Exercise Self-efficacy	Exercise self-efficacy will be assessed with a valid and reliable exercise self-efficacy questionnaire (Activities-specific Balance Confidence (ABC) score). The ABC score ranges from 0-100, with a higher score indicating a better outcome.	Change from baseline to 6 months
Secondary	Falls	Falls will be defined as any event in which the participant unintentionally comes to rest on the ground or other lower level, not as a result of a major intrinsic event or an overwhelmingly external hazard. This outcome measure is reporting the sum total number of falls for each intervention.	12 months
Secondary	Health Care Utilization	Secondary health care utilization outcomes include counts of emergency room visits.	Baseline, 6 months and 12 months
Secondary	Mini-Mental State Examination	The Mini-Mental State Questionnaire is a 30 point questionnaire that is used extensively to measure cognitive impairment. Total score = 30, score ranges are from 0 to 30. A higher score indicates better performance.	Change from baseline to 12 months