NCT02346136

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2018

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

February 21, 2020

Completed
Last Updated

February 21, 2020

Status Verified

April 1, 2018

Enrollment Period

2.5 years

First QC Date

January 20, 2015

Results QC Date

December 19, 2019

Last Update Submit

February 20, 2020

Conditions

Aging

Keywords

Tai ChiCluster randomized controlled trialInterventionElderlyMobilityHealth care utilization

Outcome Measures

Primary Outcomes (2)

  • 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

  • Health Care Utilization

    Health care utilization will be defined by counts of hospitalizations during the study period.

    up to 12 months

Secondary Outcomes (12)

  • Mobility

    Change from baseline to 6 months

  • Gait Velocity

    Change from baseline to 6 months

  • Standing Balance

    Change from baseline to 6 months

  • Grip Strength

    Change from baseline to 6 months

  • Self-reported Physical Activity

    Change from baseline to 6 months

  • +7 more secondary outcomes

Study Arms (2)

Tai Chi

EXPERIMENTAL

This arm will receive a 6-month Tai Chi training intervention. Tai Chi training will include gentle dynamic stretching and strengthening, slow integrated movements, efficient posture, heightened body awareness and inner focus, active relaxation of body and mind, mindful diaphragmatic breathing, and healing imagery and intention. Participants will be asked to complete two formal group classes each week for at least 6 months, led by senior Tai Chi instructors. Additionally, participants will be given practice Digital Versatile Disc (DVD), DVD players if necessary, and instructions for daily home practice a minimum of 20 minutes on 3 non-class days each week.

Behavioral: Tai Chi training

Educational Control

ACTIVE COMPARATOR

This arm will receive a 6-month educational control intervention. Participants will attend monthly educational group sessions within a common area of each housing facility. Sessions will be led by research personnel and include material from Patient Education Forms (PEFs) produced by the American Geriatric Society. Sessions will be semi-structured and contain approximately 30 minutes of lecture and 30 minutes of group discussion.

Behavioral: Educational Control

Interventions

Tai Chi trainingBEHAVIORAL
Tai Chi
Educational ControlBEHAVIORAL
Educational Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

Location

Related Publications (2)

  • 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.

    PMID: 28694204BACKGROUND

  • 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.

    PMID: 31116883RESULT

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Eric Macklin, PhD
Organization
MGH Biostatistics
emacklin@mgh.harvard.edu
617-724-9828

Study Officials

  • Lewis Lipsitz, MD

    Director, Marcus Institute for Aging Research, Hebrew SeniorLife

    PRINCIPAL INVESTIGATOR

  • Peter Wayne, PhD

    Research Director, Osher Center, Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 26, 2015

Study Start

July 1, 2015

Primary Completion

January 10, 2018

Study Completion

January 26, 2018

Last Updated

February 21, 2020

Results First Posted

February 21, 2020

Record last verified: 2018-04

Locations

US(1)