Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Balance, Falls, Fall Risk, Aerobic Exercise, Strength Training, Fall Prevention, Stretching Exercise, Breathing Exercise, Randomized Controlled Trial, Clinical Prediction Rule, Minimal Clinically Important Difference
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.
Interventions
OTHERBalance Training
static and dynamic balance and gait stability exercises
OTHERBreathing and Stretching Exercises
static stretching while performing diaphragmatic breathing
Sponsors
Texas Woman's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The patients will be blinded to their group assignment. At the time of their group assignment, they will be told that they are in either group A (which is actually the experimental group receiving balance training) or B (which is actually the active control group receiving the breathing and stretching exercise program), and that both groups may lead to better balance, neither are expected to worsen balance, and it is uncertain which one is more effective at improving balance. After their study participation, patients will guess which group they were in, then told if they guessed correctly.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Balance Evaluation Systems Test total score baseline to 4 weeks | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Global Rating of Change in Balance after 4 weeks | 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 |
| Global Rating of Change in Balance after 8 weeks | 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 |
Countries
United States
Outcome results
None listed