NCT01126723

Brief Summary

The aim of this study is determine the effects of Tai Chi exercise, as compared to an education-based control intervention, on cardiovascular and balance system function in older people at risk of developing frailty. We hypothesize that long-term Tai Chi training will improve specific nonlinear properties associated of cardiovascular and balance dynamics in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 30, 2015

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

May 18, 2010

Results QC Date

January 20, 2015

Last Update Submit

December 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frailty Index

    Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.

    post-intervention

Study Arms (2)

Tai Chi group

EXPERIMENTAL
Other: Tai Chi

Educational Control group

ACTIVE COMPARATOR
Other: Education-Control

Interventions

Tai ChiOTHER

The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).

Tai Chi group

The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)

Educational Control group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men and women over age 70 will be included if they are able to stand and walk unassisted, are free of any acute or unstable medical conditions, and are able to understand directions and participate in the protocol.

You may not qualify if:

  • Potential subjects will be excluded 1) if they cannot stand and ambulate unassisted, 2) are experiencing any symptomatic cardiovascular or respiratory disease, or have 3) a myocardial infarction or stroke within 6 months, 4) painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility, 5) systolic BP above 160 or diastolic BP above 100 mm Hg, 6) a cardiac pacemaker, 7) Parkinson's Disease or other neuromuscular disorder, 8) metastatic cancer or immunosuppressive therapy, or 9) have significant visual impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

Location

MeSH Terms

Conditions

Frailty

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Results Point of Contact

Title
Dr. Lewis Lipsitz
Organization
Institute for Aging Research, Hebrew SeniorLife

Study Officials

  • Lewis Lipsitz, MD

    Hebrew Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2010

First Posted

May 20, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 19, 2023

Results First Posted

January 30, 2015

Record last verified: 2023-12

Locations