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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03086772
Other study ID # R21AG043883
Secondary ID R21AG043883
Status Completed
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date April 2017

Study information

Verified date October 2018
Source University of Massachusetts, Boston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Older adults aged ≥65 years with multisite pain who reported falling in the past year or current use of an assistive device were recruited from Boston area communities. Participants were randomized to either a Tai Chi (N=28) or a light physical exercise (N=26) program, offered twice weekly for 12 weeks. The primary outcomes were feasibility and acceptability of the 12-week Tai Chi/light exercise program. Secondary outcomes included pain characteristics (pain severity and pain interference), cognition (attention and executive function), physical function (walking speed, strength, and balance), gait mobility (singe-task and dual-task gait), levels of pain-related markers (C-reactive protein, interleukin 6, tumor necrosis factor alpha, and beta endorphin), fear of falling, and rate of falls.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Regular Tai Chi practice

- Unstable cardiac disease

- Stroke

- Rheumatoid arthritis

- Degenerative neuromuscular disease

- Parkinson's disease

- Terminal disease

- Dementing illness

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Tai Chi
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.
Light Exercise
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.

Locations

Country Name City State
United States University of Massachusetts, Boston Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
University of Massachusetts, Boston National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & 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 Mar 6. doi: 10.1007/s40520-018-0922-0. [Epub ahead — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pain characteristics Pain severity and interference were evaluated by using the Brief Pain Inventory (BPI) questionnaire. Before and after the 12-week intervention period
Secondary Cognition Attention was evaluated by using the Test of Everyday Attention (TEA) questionnaire. Executive function was evaluated by using the Trailmaking A and B tests questionnaire. Before and after the 12-week intervention period
Secondary Physical function Physical function was measured by using the Short Physical Performance Battery (SPPB) Before and after the 12-week intervention period
Secondary Gait mobility Single-task and dual-task gait function was determined by using the PKMAS software and Zeno walkway. Before and after the 12-week intervention period
Secondary Pain-related biomarkers Levels of inflammatory markers and beta endorphin were determined by using biochemistry assays. Before and after the 12-week intervention period
Secondary Fear of falling Fear of falling was measured using the Tinetti Falls Effi- cacy Scale. Before and after the 12-week intervention period
Secondary Rate of falls Rate of falls were recorded by using monthly fall calendars. Over the 12-week intervention and 6 months following the intervention
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