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

Study 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.

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

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Other: Balance Training
* Other: Breathing and Stretching Exercises


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balance Training<br>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<br>* static and dynamic balance and gait stability exercises<br>|
| Active Comparator: Breathing and Stretching Exercises<br>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<br>* static stretching while performing diaphragmatic breathing<br>|

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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Balance, Falls, Fall Risk, Aerobic Exercise, Strength Training, Fall Prevention, Stretching Exercise, Breathing Exercise, Randomized Controlled Trial, Clinical Prediction Rule, Minimal Clinically Important Difference