NCT02551666

Brief Summary

Falls are the leading cause of injuries and injury-related deaths among older adults over the age of 65 in the United States. To help reduce the number of these falls, there is growing interest in using reactive balance training to improve the reactive response to common perturbations (e.g., tripping and slipping). The goal of this study was to compare treadmill-based reactive balance training versus Tai Chi performed at, and among residents of, older adult senior housing. We hypothesized that participants randomized to reactive balance training (RBT) would show better performance on reactive balance tests compared to participants randomized to Tai Chi. We also hypothesized that participants randomized to Tai Chi would show better performance on clinical tests of balance and mobility compared to participants randomized to RBT. The long-term goal of this work is to demonstrate the value of RBT over Tai Chi for preventing falls resulting from sudden, external perturbations. Thirty-five residents of five senior housing facilities were allocated to either treadmill-based reactive balance training or Tai Chi training. Both interventions were performed three times per week for four weeks, with each session lasting approximately 30 minutes. A battery of balance tests was performed at baseline, and again one week, one month, three months, and six months post-training. The battery included six standard clinical tests of balance and mobility, and a test of reactive balance performance.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

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

First Submitted

Initial submission to the registry

August 12, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 14, 2020

Completed
Last Updated

July 14, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

August 12, 2015

Results QC Date

January 13, 2020

Last Update Submit

June 29, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Maximum Torso Angle at 0.8 Mph

    maximum torso angle during a simulated trip, and be measures in degrees. Larger angles indicate worse performance.

    1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

  • Maximum Torso Angle at 1.6 Mph

    maximum torso angle during a simulated trip, and be measures in degrees. Larger angles indicate worse performance.

    1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

Secondary Outcomes (9)

  • Reactive Balance Rating

    1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

  • Step Length at 0.8 Mph

    1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

  • Timed-up-and-go Test

    1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

  • Unipedal Stance Time Test

    1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

  • Maximum Step Length Test

    1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

  • +4 more secondary outcomes

Study Arms (2)

Tai Chi exercise intervention

ACTIVE COMPARATOR

Participants will perform 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks.

Other: Tai Chi exercise

Balance recovery training

EXPERIMENTAL

Participants will practice balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks.

Other: Balance recovery training

Interventions

Participants will practice recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions will last approximately 30 minutes, and will be performed 3 times per week for 4 weeks.

Balance recovery training

Participants will perform Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session will be led by an experienced Tai Chi instructor.

Tai Chi exercise intervention

Eligibility Criteria

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

You may qualify if:

  • Must be age 70 or older
  • Must be a resident of local continuing care retirement community (CCRC)
  • Must be able to walk down a long hallway without any aids (cane, walker, etc.)
  • Must not have a fragility fracture in the past 10 years
  • Must not smoke
  • Must not be in physical therapy
  • Must not perform more than 150 minutes/week of moderate to vigorous aerobic activity
  • Must score 24 or higher on Folstein Mini Mental Status Exam
  • Must have less than 20% probability of major osteoporotic fracture as assessed by the fracture risk assessment tool (FRAX) score
  • Must not have recently (within 1 year) participated in Tai Chi

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Madigan ML, Aviles J, Allin LJ, Nussbaum MA, Alexander NB. A Reactive Balance Rating Method That Correlates With Kinematics After Trip-like Perturbations on a Treadmill and Fall Risk Among Residents of Older Adult Congregate Housing. J Gerontol A Biol Sci Med Sci. 2018 Aug 10;73(9):1222-1228. doi: 10.1093/gerona/gly077.

MeSH Terms

Interventions

Aquatic Therapy

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Limitations and Caveats

Sample size was not sufficient to investigate falls as an outcome.

Results Point of Contact

Title
Professor Michael L. Madigan, PhD
Organization
Virginia Tech

Study Officials

  • Michael Madigan, PhD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Biomedical Engineering

Study Record Dates

First Submitted

August 12, 2015

First Posted

September 16, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 14, 2020

Results First Posted

July 14, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

All outcome measures at the time points described above will be shared with other researchers.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
These data will be made available starting one year after publication.
Access Criteria
Access will be provided for supplementary analyses. IPD will be shared via email.