Clinical trial NCT05173532: The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
Official title: The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
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
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 88
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Brief Balance Evaluation Systems Test total score baseline to 4 weeks
timeFrame: 4 weeks
measure: Change in Brief Balance Evaluation Systems Test total score baseline to 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Global Rating of Change in Balance after 4 weeks
timeFrame: 4 weeks
measure: Global Rating of Change in Balance after 8 weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Breathing Center of Houston
state: Texas
city: Houston
country: United States
facility: Breathing Center of Houston
state: Texas
city: Sugar Land
country: United States
facility: Breathing Center of Houston
state: Texas
city: Webster
country: United States
facility: Breathing Center of Houston
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Christopher A Brown, PT, DPT
role: PRINCIPAL_INVESTIGATOR
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