The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Texas Woman's University
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Change in Brief Balance Evaluation Systems Test total score baseline to 4 weeks
- Last Updated
- 4 years ago
Overview
Brief 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.
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.
Investigators
Christopher Brown
Principal Investigator
Texas Woman's University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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"
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"
Secondary Outcomes
- Global Rating of Change in Balance after 8 weeks(8 weeks)
- Global Rating of Change in Balance after 4 weeks(4 weeks)