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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05173532
• Other study ID #: IRB-FY2021-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Balance Training
static and dynamic balance and gait stability exercises
• Breathing and Stretching Exercises
static stretching while performing diaphragmatic breathing

Locations

Country	Name	City	State
United States	Breathing Center of Houston	Houston	Texas
United States	Breathing Center of Houston	Houston	Texas
United States	Breathing Center of Houston	Sugar Land	Texas
United States	Breathing Center of Houston	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Brief Balance Evaluation Systems Test total score baseline to 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
Primary	Change in Brief Balance Evaluation Systems Test total score baseline to 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	Global Rating of Change in Balance after 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
Secondary	Global Rating of Change in Balance after 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