The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD

April 26, 2022 updated by: Christopher Brown, Texas Woman's University
This study has 3 objectives: (1) demonstrate the effectiveness of balance training for people with COPD, (2) determine which patients with COPD respond best to balance training, and (3) calculate clinically meaningful changes in balance for patients with COPD.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

After receiving a detailed explanation of the study, including its risks and benefits, and providing informed consent, patients will be screened for eligibility criteria during a single 75-minute evaluation for participation in a physical therapy based pulmonary rehabilitation program. Those meeting eligibility criteria will be randomly assigned in blocks of four (by clinical site) in a single-blind manner (patients) in a 1:1 ratio to either balance training or a breathing and stretching exercise program. Both groups will receive respiratory muscle stretch exercises, aerobic exercise, strength training, and fall prevention education. The intervention phase will last 8 weeks, with patients being seen 3 times per week for 75 minute sessions supervised by a physical therapist or physical therapist assistant.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77077
        • Breathing Center of Houston
      • Houston, Texas, United States, 77081
        • Breathing Center of Houston
      • Sugar Land, Texas, United States, 77479
        • Breathing Center of Houston
      • Webster, Texas, United States, 77598
        • Breathing Center of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • having reported a fall in the past 5 years, or a near fall in the past year, or a score ≥ 9 on the Short Version of the Falls Efficacy Scale - International Version
  • age ≥ 60 years
  • both sexes
  • spirometrically-confirmed COPD of all disease severity stages
  • being independently ambulatory with or without a gait aid
  • medical clearance by a physician to participate in pulmonary rehabilitation
  • provision of informed consent.

Exclusion Criteria:

  • having suffered a recent, severe COPD exacerbation (recent is 30 days or less prior to the study baseline)
  • participation in a formal exercise program in the three months prior to the study baseline
  • an inability by the patient to complete all study testing due to physical, psychological, communication-barrier, or other unanticipated reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Balance Training
Static and dynamic balance and gait stability training exercises are performed with supervision by a physical therapist or physical therapist assistant for 30 minutes, 3 times per week, for 8 weeks.
Other: Balance Training
static and dynamic balance and gait stability exercises
Active Comparator: Breathing and Stretching Exercises
Patients perform static stretches for all major muscle groups while performing diaphragmatic breathing with supervision by a physical therapist or physical therapist assistant for 30 minutes, 3 times per week, for 8 weeks.
Other: Breathing and Stretching Exercises
static stretching while performing diaphragmatic breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brief Balance Evaluation Systems Test total score baseline to 4 weeks
Time Frame: 4 weeks
8-item balance test battery, each item rated from 0-3 then summed for total score, items #3 and #4 are tested on both the right and left side. (#1) HIP/TRUNK LATERAL STRENGTH, (#2) FUNCTIONAL REACH FORWARD, (#3) SINGLE-LEG STANCE, (#4) COMPENSATORY STEPPING CORRECTION- LATERAL, (#5) STAND ON FOAM, EYES CLOSED: (3) 30s stable (2) 30s unstable (1) < 30s (0) Unable, (#6) TIMED "GET UP & GO"
4 weeks
Change in Brief Balance Evaluation Systems Test total score baseline to 8 weeks
Time Frame: 8 weeks
8-item balance test battery, each item rated from 0-3, then summed for total score, items #3 and #4 are tested on both the right and left side. (#1) HIP/TRUNK LATERAL STRENGTH, (#2) FUNCTIONAL REACH FORWARD, (#3) SINGLE-LEG STANCE, (#4) COMPENSATORY STEPPING CORRECTION- LATERAL, (#5) STAND ON FOAM, EYES CLOSED: (3) 30s stable (2) 30s unstable (1) < 30s (0) Unable, (#6) TIMED "GET UP & GO"
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Rating of Change in Balance after 4 weeks
Time Frame: 4 weeks
11-point self-report outcome rating balance improvement(+) or decline(-). Ratings: (+/-5)="very large", (+/-4)="large", (+/-3)="medium", (+/-2)="small", (+/-1)="very small", (0)="none"
4 weeks
Global Rating of Change in Balance after 8 weeks
Time Frame: 8 weeks
11-point self-report outcome rating balance improvement(+) or decline(-). Ratings: (+/-5)="very large", (+/-4)="large", (+/-3)="medium", (+/-2)="small", (+/-1)="very small", (0)="none"
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Woman's University

Investigators

  • Principal Investigator: Christopher A Brown, PT, DPT, Texas Woman's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-FY2021-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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