The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Change in Brief Balance Evaluation Systems Test total score baseline to 4 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Balance Training (Other)
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.
干预措施: Breathing and Stretching Exercises (Other)
结局指标
主要结局
Change in Brief Balance Evaluation Systems Test total score baseline to 4 weeks
时间窗: 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
时间窗: 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"
次要结局
- Global Rating of Change in Balance after 8 weeks(8 weeks)
- Global Rating of Change in Balance after 4 weeks(4 weeks)
研究者
Christopher Brown
Principal Investigator
Texas Woman's University