The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
NCT ID: NCT05173532
Last Updated: 2022-04-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
88 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-02-10
Study Completion Date
2022-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Pulmonary Disease, Chronic Obstructive
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
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.
Study Groups
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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.
Group Type
EXPERIMENTAL
Balance Training
Intervention Type
OTHER
static and dynamic balance and gait stability exercises
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.
Group Type
ACTIVE_COMPARATOR
Breathing and Stretching Exercises
Intervention Type
OTHER
static stretching while performing diaphragmatic breathing
Interventions
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Balance Training
static and dynamic balance and gait stability exercises
Intervention Type
OTHER
Breathing and Stretching Exercises
static stretching while performing diaphragmatic breathing
Intervention Type
OTHER
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Texas Woman's University
OTHER
Sponsor Role
lead
Responsible Party
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Christopher Brown
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Christopher A Brown, PT, DPT
Role: PRINCIPAL_INVESTIGATOR
Texas Woman's University
Locations
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Breathing Center of Houston
Houston, Texas, United States
Site Status
Breathing Center of Houston
Houston, Texas, United States
Site Status
Breathing Center of Houston
Sugar Land, Texas, United States
Site Status
Breathing Center of Houston
Webster, Texas, United States
Site Status
Countries
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United States
References
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Beauchamp MK, Janaudis-Ferreira T, Parreira V, Romano JM, Woon L, Goldstein RS, Brooks D. A randomized controlled trial of balance training during pulmonary rehabilitation for individuals with COPD. Chest. 2013 Dec;144(6):1803-1810. doi: 10.1378/chest.13-1093.
Reference Type
BACKGROUND
Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.
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Moon Y, Sosnoff JJ. Safe Landing Strategies During a Fall: Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2017 Apr;98(4):783-794. doi: 10.1016/j.apmr.2016.08.460. Epub 2016 Aug 31.
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Mansfield A, Wong JS, Bryce J, Knorr S, Patterson KK. Does perturbation-based balance training prevent falls? Systematic review and meta-analysis of preliminary randomized controlled trials. Phys Ther. 2015 May;95(5):700-9. doi: 10.2522/ptj.20140090. Epub 2014 Dec 18.
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BACKGROUND
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Reference Type
BACKGROUND
Beauchamp MK, Harrison SL, Goldstein RS, Brooks D. Interpretability of Change Scores in Measures of Balance in People With COPD. Chest. 2016 Mar;149(3):696-703. doi: 10.1378/chest.15-0717. Epub 2016 Jan 12.
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BACKGROUND
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BACKGROUND
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Reference Type
RESULT
Garvey C, Bayles MP, Hamm LF, Hill K, Holland A, Limberg TM, Spruit MA. Pulmonary Rehabilitation Exercise Prescription in Chronic Obstructive Pulmonary Disease: Review of Selected Guidelines: AN OFFICIAL STATEMENT FROM THE AMERICAN ASSOCIATION OF CARDIOVASCULAR AND PULMONARY REHABILITATION. J Cardiopulm Rehabil Prev. 2016 Mar-Apr;36(2):75-83. doi: 10.1097/HCR.0000000000000171.
Reference Type
RESULT
Other Identifiers
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IRB-FY2021-1
Identifier Type: -
Identifier Source: org_study_id
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