NCT03086772

Brief Summary

The main purpose of this randomized controlled trial was to assess the feasibility and acceptability of a 12-week Tai Chi program for community-dwelling older adults with chronic multisite pain and a history of falling. In addition, the investigators examined the effects of Tai Chi on pain characteristics, cognition, physical function, gait mobility, levels of pain-related biomarkers, fear of falling and rate of falls in these older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started May 2014

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

2.9 years

First QC Date

June 4, 2015

Last Update Submit

October 23, 2018

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Feasibility and acceptability of the 12-week Tai Chi program

    Feasibility and acceptability were evaluated by adherence, attendance, optimal program components, and safety.

    Over the 12-week intervention period

Secondary Outcomes (7)

  • Pain characteristics

    Before and after the 12-week intervention period

  • Cognition

    Before and after the 12-week intervention period

  • Physical function

    Before and after the 12-week intervention period

  • Gait mobility

    Before and after the 12-week intervention period

  • Pain-related biomarkers

    Before and after the 12-week intervention period

  • +2 more secondary outcomes

Study Arms (2)

Tai Chi

EXPERIMENTAL

Individuals in the Tai Chi intervention group participated in a 12-week Tai Chi program.

Behavioral: Tai Chi

Light Exercise

ACTIVE COMPARATOR

Individuals in the exercise control group performed a 12-week light exercise program.

Behavioral: Light Exercise

Interventions

Tai ChiBEHAVIORAL

Individuals in the Tai Chi intervention group will participate in a 12-week Tai Chi program (one hour per class, two classes per week, plus home practice for 12 weeks) led by an experienced Tai Chi Instructor, assisted by an undergraduate research assistant.

Tai Chi
Light ExerciseBEHAVIORAL

Individuals in the exercise control group will meet for a twice weekly class involving walking, weight training, stretching and health education (one hour per class, two classes per week for 12 weeks, taught by a trained graduate research assistant, assisted by an undergraduate research assistant.

Light Exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age of 65 years and older
  • Multisite (2 or more sites) musculoskeletal pain
  • At least one fall in the past year, or currently on an assistive device
  • A sedentary lifestyle
  • Be able to walk 20-feet without personal assistance
  • Be able to communicate in English.

You may not qualify if:

  • Regular Tai Chi practice
  • Unstable cardiac disease
  • Stroke
  • Rheumatoid arthritis
  • Degenerative neuromuscular disease
  • Parkinson's disease
  • Terminal disease
  • Dementing illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts, Boston

Boston, Massachusetts, 02125, United States

Location

Related Publications (1)

  • You T, Ogawa EF, Thapa S, Cai Y, Zhang H, Nagae S, Yeh GY, Wayne PM, Shi L, Leveille SG. Tai Chi for older adults with chronic multisite pain: a randomized controlled pilot study. Aging Clin Exp Res. 2018 Nov;30(11):1335-1343. doi: 10.1007/s40520-018-0922-0. Epub 2018 Mar 6.

    PMID: 29512041RESULT

MeSH Terms

Conditions

Chronic Pain

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Tongjian You, PhD

    University of Massachusetts, Boston

    PRINCIPAL INVESTIGATOR

  • Suzanne Leveille, PhD

    University of Massachusetts, Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2015

First Posted

March 22, 2017

Study Start

May 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

October 25, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)